Family planning methods: new guidance

Family planning methods: new guidance

Current scientific findings increase choices for family planning clients while making contraceptive use even safer and more effective. On this basis, service delivery practices can be updated to improve quality and access.

Based on scientific evidence, two expert groups, working collaboratively, offer new guidance for family planning service delivery. One group answers key biomedical questions about contraceptive practices. The Technical Guidance/Competence Working Group is a part of the Maximizing Access and Quality initiative, a joint effort of the US Agency for International Development, its Cooperating Agencies, and other experts. The other guidance recommends medical eligibility criteria for who can use each major contraceptive method and who should not. Both sets of recommendations are endorsed by the World Health Organization/Family Planning and Population Unit, which also organized the latter group.

In general, the new guidance, summarized in this issue, helps providers give clients more choice among contraceptive methods, about when to start methods, and about obtaining and using them conveniently. The recommendations imply ending some practices that burden clients without benefiting them. Also, the new guidance assists providers helping clients to use their chosen methods effectively and to deal with side effects. It indicates what clinical practices are important to providing and using various methods safely and effectively.

This new guidance is not intended as off-the-shelf program guidelines. Rather, it should be adapted to local needs, providing the sense and the science behind practices that maximize service quality and access.

Combined Oral Contraceptives

These recommendations presume the COCs used will contain no more than 35 [mu]g of ethinyl estradiol (or similar estrogen).

Q.1. When is the best time to start COCs?

Recommendation: COCs may be started any time you can be reasonably sure that the woman is not pregnant (see p. 33), for example, during the 7 days that begin with the onset of menses (days 1 through 7 of the menstrual cycle).

Rationale: Starting within the first 7 days lowers the possibility of beginning the pill while she is already pregnant (although there is the possibility that the client is pregnant and implantation bleeding has been mistaken for menses) (66,104, 238).

Recommendation: For a woman having menstrual cycles, no back-up method is needed if she is in the first 7 days of her menstrual cycle and is still menstruating. If she is in the first 7 days of her cycle but is not menstruating, some programs may recommend use of a back-up method for 1 week.

COCs may be started anytime you can be reasonably sure the woman is not pregnant (see p. 33). However, if COCs are started after day 7 of a regular cycle, the woman should also be counseled that:

* Her regular bleeding pattern may be altered, and

* A back-up method (or abstinence) shoUld be used for 7 days.

(For information concerning need for back-up method, see Question 6.)

Rationale: A back-up method is NOT needed if the first package of pills is started while the woman is menstruating because the risk of conception is virtually nil. After day 5 of the cycle, the risk of pregnancy begins to rise (257).

Some programs might recommend a backup method for women who are not menstruating at the time of COC initiation because there is a very slight risk of conception from unprotected intercourse on day 7 of the cycle.

When back-up (or abstinence) is needed, it must be used for 7 days because 7 days of exposure to COCs are required to suppress follicular development (195).

Recommendation: If the client is using the 28-day pill packet, she should start a new packet the day after she finishes the previous packet (without a break). If the client is using the 21-day pill packet, she should skip 7 days before starting a new packet. If the pills are taken correctly, the client will always begin a new packet on the same day of the week.

Rationale: The longer the pill-free interval, the higher the risk of ovulation (e.g., a 10-day pill free interval confers a 10% risk of ovulation) (150, 168).

Q.2. When can COCs be started postpartum?

For breastfeeding women

These restrictions do not apply to women who are only doing token, i.e., minimal, breastfeeding.

Recommendation: COCs should not be used in the first 6 weeks postpartum. COCs are considered by many experts to be the method of LAST choice during any state of lactation, especially in the first 6 weeks to 6 months.

After 6 to 8 weeks postpartum, breastfeeding women desiring hormonal contraception should be encouraged to use progestin-only pills (POPs) or injectables or Norplant[R] implants. (Before 6 to 8 weeks postpartum, there is no risk of conception for a fully or nearly fully breastfeeding woman; see p. 25.)

Rationale: Even low dose (30 to 35 [mu]g of estrogen) COCs decrease breastmilk production (311).

Recommendation: If COCs remain the method of choice, but the woman chooses to rely on the lactational amenorrhea method (LAM) initially, start COCs when her menses return,(*) or when the woman is no longer fully or nearly fully breastfeeding or at 6 months postpartum, whichever comes first. COC packets may be given to the woman before this time to ensure that she is able to start the method when she needs to.

Rationale: For fully breastfeeding women, there is no known advantage to initiating COCs during LAM or while the LAM criteria apply (141, 156).

In fact, initiating COCs before they are necessary may be a disadvantage because COCs have a detrimental effect on breast milk volume and composition, which may affect the infant’s health and growth (309, 311).

Recommendation: If she does not want to rely on LAM but is breastfeeding, she should be advised to choose a nonestrogenic method. If she still makes an informed choice to use COCs, they can be started any time after the first 8 to 12 weeks postpartum if she is still amenorrheic, or whenever the service provider can be reasonably sure that the woman is not pregnant (see p. 33).

Rationale: Even low dose (30 to 35 [mu]g of estrogen) COCs decrease breastmilk production. Waiting at least 8 to 12 weeks postpartum permits breastfeeding to be better established. Whether exposure of the neonate (in the first 8 weeks) to exogenous estrogens and progestins may, in theory, affect neonatal growth and development is a question under study.

For nonbreastfeeding women

Recommendation: If not breastfeeding, a woman can begin COCs after the second to third postpartum week.

Rationale: The increased risk of venous thromboembolism associated with COCs may be important for women in the immediate postpartum period. However, blood coagulation and fibrinolysis are essentially normalized by 3 weeks postpartum (and are close to normal at 2 weeks postpartum) (51).

Q.3. May COCs be started immediately post-abortion?

Recommendation: Yes, COCs are appropriate for use immediately postabortion (spontaneous or induced), in either the first or second trimester, and should be initiated within the first 7 days postabortion (or any time you can be reasonably sure the woman is not pregnant; see p. 33).

Rationale: Ovulation returns almost immediately postabortion (spontaneous or induced): within 2 weeks for first-trimester abortion and within 4 weeks for second-trimester abortion. Within 6 weeks of abortion, 75% of women have ovulated (164).

Immediate use of COCs postabortion (spontaneous or induced) does not affect return to fertility following discontinuation of COCs (161).

Recommendation: If a client has a history or current indication of excessive clotting (coagulopathy), COCs should not be recommended.

Rationale: COCs may be safely started within the first week postabortion (spontaneous or induced). Hypercoagulability of pregnancy probably does not become clinically significant until the third trimester. However, some experts recommend starting COCs exactly one week postabortion, since there is a suggestion of a slight increase in coagulation factors measurable in the first few days after first-trimester abortion, in women initiating COCs immediately postabortion. If started later than one week, COCs may not be immediately effective because the ovary resumes follicular development as soon as one week after first-trimester (spontaneous or induced) abortion (162, 163).

Incomplete abortion may also result in a condition of excessive blood clotting (disseminated intravascular coagulation), in which estrogens should be avoided.

Q.4. Is a “rest period” advisable for women on COCs after some period of use?

Recommendation: No, a “rest period” is not necessary. A woman may use COCs for as long as she is at risk of pregnancy.

Rationale: A rest period would disrupt the woman’s preferred and successful method of contraception.

Recommendation: Stopping COCs 2 weeks before major elective surgery or after serious accidents that necessitate immobilization of the legs and resuming COCs once the woman is mobile is optimal, if she has a reliable alternative method.

Rationale: Due to the fact that estrogen may slightly increase the risk of postoperative thrombosis, it may be reasonable to stop COCs for 2 weeks before major elective surgery and resume COCs once the woman is mobile, before she resumes sexual activity. However, this small risk must be weighed against the risk of pregnancy and whether the client has a reliable alternative method (224).

Q.5. Is there a minimum age to receive COCs? A maximum?

COCs may be used at any age at which the woman is at risk of pregnancy (e.g., past menarche and through menopause).

Recommendation: Women over age 40 can take COCs provided other risk factors have been considered (e.g., smoking, high blood pressure, diabetes).

Rationale: Cardiovascular risks from COC use are minimal in healthy, nonsmoking, older women (106, 262).

Recommendation: Use of COCs does not compromise future fertility.

Rationale: On average, the return to fertility after discontinuing COCs is about 2 months longer than for nonhormonal methods. The risk of amenorrhea after discontinuing COCs is small and more common in women who had irregular menses prior to COC use. Rather than causing “post-pill amenorrhea,” COCs mask the irregular pattern by inducing cyclic withdrawal bleeding. Women who have irregular menses are more likely to develop secondary amenorrhea whether they take COCs or not (4, 29, 130, 262).

Q.6. Are back-up methods advisable in the following situations:

If the client is taking antibiotics?

Recommendation: No–except rifampin or griseofulvin (an antifungal medication).

Rationale: Rifampin/rifampicin and griseofulvin require use of a back-up method (or increased COC dose if back-up is not possible) to compensate for hepatic micro-enzyme induction. Hepatic micro-enzyme induction by rifampin lasts for 4 weeks for short-term use and for 8 weeks for long-term use. Although anecdotal reports of failure to prevent pregnancy exist for other antibiotics, epidemiologic evidence suggests that antibiotics (except rifampin and griseofulvin) do not require a back-up method (204).

If the client is taking anticonvulsants (except valproic acid)?

Recommendation: Use of one of the following may be necessary:

* Switch to Depo-Provera[R] or an effective nonhormonal method;

* A back-up method (for short-term anticonvulsant use);

* Higher-dose COCs (i.e., 50 [mu]g ethinyl estradiol (EE), or two 30 to 35 [mu]g EE COCs per day) for more efficient contraception and/or to produce regular menses without breakthrough bleeding.

Rationale: Anticonvulsants include phenobarbitol/phenobarbitone, primidone, carbamezepine, and ethosuximide. Anticonvulsants, except valproic acid, significantly increase liver metabolism of estrogen and progestins, which decreases the effectiveness of COCs.

Taking two 30 to 35 [mu]g COCs per day will provide adequate estrogen to compensate for increased metabolism. Levonorgestrel levels are also reduced by phenytoin (and presumably other anti-epileptics). Therefore, doubling up on COCs that contain levonorgestrel is particularly important (204).

If it is the client’s first cycle of COCs?

Recommendation: If she is in the first 7 days of her cycle but is not menstruating, some programs may recommend use of a back-up method for 1 week. COCs may be started any time you can be reasonably sure the woman is not pregnant (see p.33). However, if COCs are started after day 7 of a regular cycle, the woman should also be counseled that her regular bleeding pattern may be altered and that additional contraceptive protection (or abstinence) is needed for the first 7 days. Dispensing a back-up method, however, especially condoms, is a good idea in case of failures of correct use as well as for protection from sexually transmitted diseases (STDs) when needed.

Rationale: The COC effect on cervical mucus is not as strong as the effect of progestin-only methods. COCs require 7 days to suppress follicular development (260).

If the client has missed pills?

Recommendation: Back-up is needed only if 2 or more pills are missed, and back-up must be used until the client has taken 7 active pills (one active pill per day for 7 days).

Rationale: If 2 or more pills are missed, a back-up must be used until the client has taken 7 active pills. Missed pills may occur at the beginning of the cycle (extending the pill-free interval from 7 to 9 days and perhaps allowing escape ovulation to occur) (75, 150).

Seven days of exposure to COCs are required to suppress follicular development (107, 195).

If the client has diarrhea and/or vomiting?

Recommendation: Back-up may be advisable whenever vomiting or severe diarrhea occurs within one hour after taking the tablet. If vomiting or severe diarrhea persists for more than 24 hours (then 2 pills will have been missed), a back-up method will be needed (until client has taken one active pill per day for 7 days).

Rationale: Acute vomiting and severe diarrhea may interfere with the effectiveness of the pill. In these cases, a back-up method is reasonable (204,205).

If the client is taking antimalarial medication?

Recommendation: No back-up is needed.

Rationale: Antimalarials studied to date have not been found to decrease the efficacy of COCs. Chloroquine and primaquine have not demonstrated an effect on plasma COC hormonal levels or on ovulation inhibition. Tetracycline (which is used at low dosage in combination with quinine) has not been found to compromise the effect of COCs (15, 50, 108, 197).

Q.7. When in the cycle can one switch from COCs to other methods?

Recommendation: A client can switch methods at any time. If she has been taking the pills correctly and consistently, you can be reasonably sure she is not pregnant.

A back-up method is not required unless the woman is switching to injectables or Norplant implants. The provider may want to recommend that she continue to take her COC the day she gets her first injection or the implants.

Some clinicians recommend that the woman finish her pack of pills to delay the onset of her next bleed.

Rationale: Injectables and Norplant implants are most likely effective within 24 hours, unless the woman already has fertile cervical mucus. The woman should take her pill as a back-up if she is not menstruating because there is a slight risk of conception from unprotected intercourse during those 24 hours until the injectable or implants become effective (219, 270).

Q.8. How should amenorrhea in COC users be addressed?

Recommendation: Amenorrhea is not unusual among COC users. The possibility of pregnancy should be considered. If the woman is correctly and consistently taking COCs and has no other symptoms of pregnancy, only reassurance is needed because the probability of pregnancy is extremely low. Even if the woman is pregnant and the embryo is exposed to COCs, the best evidence is that there is no harm to the embryo.

If symptoms or other reasons to suspect pregnancy exist, such as missed pills, evaluate accordingly. If pregnancy evaluation cannot be performed immediately, the client can be advised to continue taking the pills until this evaluation is completed, or she can be referred to a health unit where she can be evaluated.

Rationale: Amenorrhea may be a side effect of COCs. Amenorrhea is not uncommon in women using the low dose pills, 35 [mu]g or less of estrogen, due to a lack of buildup of the uterine lining.

While pregnancy is a possibility, COCs are over 99% effective when used correctly.

It is always recommended that a pregnant woman avoid unnecessary medication. However, if the woman is pregnant and is using COCs, there does not seem to be an increased risk of birth defects for the embryo (28, 114, 251).

Q.9. Does a client need to visit a clinic or see a doctor to receive COCs?

Recommendation: No. Trained providers other than doctors, including community-based distribution (CBD) workers, can initiate and resupply COCs both in clinical and nonclinical situations. Additionally, COCs may be provided “over-the-counter” if adequate information is given to clients (see Table, p. 34, for suitable counseling points).

Importance of Selected Procedures for Providing Family Planning Methods

Class A = Essential and required or otherwise important for safe of the family planning methold

Class B = Makes medical sense in some cases for safest use of the family planning method but may not be appropriate for all clients in all settings.

Class C = May be appropriate for good preventive health care but not materially related to safe use of the family planning method

Low-Dose Progestin-Only

Procedure Combined Oral Pills During

Contraceptions Breastfeeding

Pelvic exam (spectrum and

bimanual) for women;

genital exam for men C C

Blood pressure reading B C

Breast exam B C

STD screening by lab tests

(for persons without symptoms) C C

Cervical cancer screening C C

Routine, mandatory lab tests

(for example, cholesterol,

glucose, liver function tests) D D

Proper infection-prevention

procedures C C

Specific counseling points for

family planning method(***) A(5) A(5)

Counseling about change in menses,

including irregular or absent A A

menstrual bleeding

DMPA & NET EN Norplant

Procedure Injectables Implants

Pelvic exam (spectrum and

bimanual) for women;

genital exam for men C C

Blood pressure reading C C

Breast exam C C

STD screening by lab tests

(for persons without symptoms) C C

Cervical cancer screening C C

Routine, mandatory lab tests

(for example, cholesterol,

glucose, liver function tests) D D

Proper infection-prevention

procedures A A

Specific counseling points for

family planning method(***) A A

Counseling about change in menses,

including irregular or absent A A

menstrual bleeding

Female

Procedure Sterilization(*) Vasectomy

Pelvic exam (spectrum and

bimanual) for women;

genital exam for men A A

Blood pressure reading A C

Breast exam C NA

STD screening by lab tests

(for persons without symptoms) C C

Cervical cancer screening C NA

Routine, mandatory lab tests

(for example, cholesterol, C(3) D

glucose, liver function tests)

Proper infection-prevention

procedures A A

Specific counseling points for

family planning method(***) A(6) A(6)

Counseling about change in menses,

including irregular or absent — NA

menstrual bleeding

Barrier Copper

Procedure Methods(**) IUDs

Pelvic exam (spectrum and

bimanual) for women;

genital exam for men C(1) A

Blood pressure reading C C

Breast exam C C

STD screening by lab tests

(for persons without symptoms) C B(2)

Cervical cancer screening C C

Routine, mandatory lab tests

(for example, cholesterol,

glucose, liver function tests) D D

Proper infection-prevention

procedures C(4) A

Specific counseling points for

family planning method(***) B(7) A(8)

Counseling about change in menses,

including irregular or absent — A

menstrual bleeding

Lactational Fertility

Precedure Amenorrhea Awareness-Based

Method (LAM) Methods

Pelvic exam (spectrum and

bimanual) for women;

genital exam for men C C

Blood pressure reading C C

Breast exam C C

STD screening by lab tests

(for persons without symptoms) C C

Cervical cancer screening C C

Routine, mandatory lab tests

(for example, cholesterol,

glucose, liver function tests) — —

Proper infection-prevention

procedures C C

Specific counseling points for

family planning method(***) A(9) A(10)

Counseling about change in menses,

including irregular or absent — —

menstrual bleeding

Recommendation: It is unlikely that broad spectrum antibiotics significantly affect the action of COCs, including ECPs.

Rationale: There is evidence that broad spectrum antibiotics do not decrease COC effectiveness, and so, in the absence of data for ECPs, the experts presume no clinically important effects on ECP use, either (16, 334, 337, 343).

Q.14. May ECPs be provided in advance of possible unprotected intercourse?

Recommendation: Yes. Providing ECPs in advance will improve access to the method and the ability of the client to use the regimen within the recommended 72 hours.

For example, when a woman visits a provider for gynecological care, contraception, or sexually transmitted disease treatment, she can be provided with ECPs and counseled on their use.

Providing ECP information and supplies (or a prescription) in advance may be especially relevant for women relying on barrier methods or periodic abstinence.

Rationale: The Yuzpe regimen is quite safe. If the prescription guidelines are followed by the provider, it is highly unlikely that women would suffer adverse affects from the regimen. In addition, ECPs help protect a woman from pregnancy and abortion, which are more dangerous than ECP use.

Difficulty in getting access to ECPs within 72 hours of unprotected intercourse is a barrier to use. Providing ECP information and supplies (or a prescription) in advance can be convenient for both providers and women, educates women about how ECPs may be of use, eliminates the need for another clinic visit, and ensures that ECPs are available promptly after unprotected intercourse (274, 291, 336, 350, 353).

Q.15. What contraceptive methods are appropriate for immediate initiation after use of ECPs? When are they appropriate to start?

Recommendation: Barrier methods and other nonhormonal methods may be initiated immediately after ECP use.

Oral contraceptives may be initiated immediately after ECP use (with routine screening). With routine screening, some providers also provide DMPA immediately, because of the low risk of pregnancy (2%) following ECP use and the low risk of teratogenic effects; other providers await the start of menses before providing injectable contraceptives.

Once one can be reasonably sure the woman is not pregnant after ECP use (e.g., arrival of menses), long-term methods such as an IUD or Norplant implants can be initiated.

If an IUD is an appropriate choice, it could be used as an emergency contraceptive. According to WHO, copper-bearing IUDs can be inserted up to five days after unprotected intercourse.

Rationale: There are no clinical data indicating that one method is more appropriate than another for use after ECPs. The choice should be made by the client and the provider. If the client was a pill user when she came in for ECPs, the reason for her missed pills should be discussed.

It is always recommended that a pregnant woman avoid unnecessary medication. However, if the woman is already pregnant or becomes pregnant due to failure of ECPs, and has choosen a hormonal method, the best evidence indicates no increased risk of birth defects for the fetus (28, 251, 291, 302).

Use of IUDs for emergency contraception is not recommended for women with an established pregnancy nor for women who are not medically eligible for continuing IUD use (302).

Q.16. Should ECP use be restricted to the time around expected ovulation?

Recommendation: No. ECPs can be used at any time during the menstrual cycle. If the client is concerned about the risk of pregnancy, she should receive ECPs regardless of the timing. This is especially true if the client has been using oral contraceptives. COC users do not have a menstrual cycle as such.

Rationale: It is difficult to know when ovulation occurs in a given cycle, particularly for women with irregular cycles. The risk of conception is highest between 6 days before and 1 day after ovulation (290, 355).

COC users do not have a “menstrual cycle” per se; missed COCs can permit follicular development, which can lead to ovulation (150, 168).

Progestin-Only Pills During Breastfeeding

Because the vast majority of progestin-only pill (POP) users are breastfeeding women, this chapter focuses on POPs during breastfeeding. However, POPs are an acceptable contraceptive method for use by women who are not breastfeeding.

Q.1. When can POPs be started for breastfeeding women?

Recommendation: If breastfeeding, POPs may be started after 6 weeks postpartum.

POPs are not usually recommended in the first 6 weeks postpartum in breastfeeding women. The timing of postpartum initiation of POPs should consider a woman’s breastfeeding intentions.

Rationale: For breastfeeding women, delaying POP initiation for 6 weeks after delivery avoids exposing the newborn to exogenous steroids during the time of greatest neuroendocrine development. In breastfeeding women, the risk of ovulating in the first 6 weeks postpartum is very low. The timing of postpartum initiation of POPs should be dependent on the woman’s preference, her previous experience with breastfeeding, and her intentions regarding the duration of breastfeeding (64, 119, 285).

Recommendation: A woman who initially chooses to rely on the Lactational Amenorrhea Method (LAM) is advised to begin POPs or whichever method she chooses to switch to:

* When her menses return, or

* When she is no longer fully or nearly fully breastfeeding, or

* At 6 months postpartum, whichever comes first.

Preferably, POP packets are given to the woman before her intended start date to ensure that she is able to begin the method when she needs to. However, if she prefers, POPs can also be started when a woman is still relying on LAM (providing her with dual protection).

Rationale: While relying on LAM, a postpartum woman has at least 98% protection from pregnancy for 6 months if she remains amenorrheic and fully or nearly fully breastfeeds (perfect use-effectiveness rate). Programs sometimes encourage waiting to initiate POPs until reliance on LAM ends because it may be more programmatically affordable and because using POPs while breastfeeding may potentially prolong lactational subfertility (34, 146).

Recommendation: After the first 6 weeks postpartum, POPs can be initiated any time you can be reasonably sure a woman is not pregnant (see p. 33 and POP Question 5).

Rationale: Based on current literature, including studies with other progestin-only methods, it is unlikely that there is a significant effect on the growth of breastfeeding infants whose mothers initiate POPs after the sixth postpartum week (187, 213, 241, 311).

Recommendation: Even if POPs are inadvertently initiated during pregnancy, there is no known risk to the fetus.

Rationale: Epidemiologic studies have found no significant effect on fetal development or malformations due to taking hormonal methods in early pregnancy (28, 251, 298).

Recommendation: Nonhormonal methods are preferable to hormonal methods during breastfeeding because they have no effect on breastfeeding and the infant is not exposed to exogenous steroids. However, WHO lists POPs as Category 1 (no restrictions) after 6 weeks postpartum, and women should be given a choice of contraceptive methods.

Rationale: Although the amount of exogenous progestins in breastmilk is extremely low, it is prudent to try to minimize infant exposures to any drug (302, 335).

Q.2. Are there special considerations when switching from POPs to other hormonal methods?

Recommendation: No. A breastfeeding woman can switch from POPs to another hormonal method any time the new method is appropriate.

No back-up method is necessary when the new method is initiated if the woman has been breastfeeding and has been taking the POPs fairly consistently. Estrogen-containing methods should generally not be used by breastfeeding women prior to 6 months postpartum or preferably any time during long-term breastfeeding.

Rationale: As long as the woman is breastfeeding and taking the POPs fairly consistently, she is fully protected through the transition to the new hormonal method (108).

Clinical trial data indicate that the pregnancy protection conferred by POP use during breastfeeding is high, indicating a synergistic pregnancy prevention effect for breastfeeding while using POPs. In addition, women in lactational amenorrhea have additional protection due to their lowered fecundity (69, 147).

Q.3. If a woman is using POPs during breastfeeding, when should she be advised to switch to another method?

Recommendation: Women can rely on POPs after the first 6 weeks and safely use them during the entire duration of breastfeeding.

Rationale: In general, POPs are highly effective and safe during breastfeeding (69, 188).

Recommendation: Women can continue using POPs after they stop breastfeeding, provided that they have been informed of the advantages and disadvantages of the method and are willing to use the POPs correctly and consistently.

It is not mandatory for a woman to switch from POPs to another family planning method after she stops breastfeeding or at 6 months postpartum.

Rationale: POPs are an effective contraceptive method, even when not breastfeeding, if used correctly and consistently. However, all women should be informed of the advantages and disadvantages of POPs in the absence of breastfeeding, especially that POPs need to be used consistently and correctly to provide effective pregnancy protection and that they often cause irregular menstrual bleeding (188, 285, 302).

Recommendation: Breastfeeding women using POPs should be advised not to switch to COCs or other methods containing estrogen until at least 6 months postpartum.

Rationale: Even low-dose (30 [mu]g) COCs decrease breastmilk production and alter its composition (188, 311).

Recommendation: Breastfeeding women can switch to nonhormonal methods at any time, as appropriate.

Rationale: If not inserted with 48 hours of delivery, postpartum IUDs are usually not inserted until uterine involution is complete. Progestin-releasing IUDs are not inserted until 6 weeks postpartum, even if involution is complete before 6 weeks, to avoid the theoretical risks of exposing the infant to steroids. Diaphragms are not fitted until involution is complete (203, 296, 302).

Q.4. When breastfeeding, is there a best time of day to take POPs?

Recommendation: POPs may be taken at any time of the day for effective use during breastfeeding. The client may wish to select a certain time to help her remember to take a pill every day; it may help to link this time to a daily event.

Rationale: Breastfeeding women have additional protection due to their lower fecundity. Clinical trial data indicate that the pregnancy protection conferred by POP use during breastfeeding is extremely high. The synergistic pregnancy protection by POP use in combination with breastfeeding should sufficiently eliminate a client’s risk of conception, even if she takes POPs at different times of the day (39, 64, 188, 317).

Recommendation: However, if a woman continues taking POPs after breastfeeding cessation, then it is important to take the POP at the same time every day, preferably late afternoon or 4 to 5 hours before the usual time of sexual activity, so that the pill’s effect on the cervical mucus is at its maximum by the time sexual activity occurs.

Q.5. Are back-up methods advisable in the following situations

If a breastfeeding client is taking antibiotics, including antituberculosis medications?

Recommendation: Back-up methods are not usually required, Unless the woman is taking rifampin/rifampicin.

With the exception of rifampin/rifampicin, antibiotics are unlikely to significantly reduce the effectiveness of POPs in breastfeeding women.

If the breastfeeding woman is taking rifampin/rifampicin, she should know that rifampin/rifampicin:

* Passes through breastmilk (with potential side effects on the infant) and

* May increase breakthrough bleeding, lower progestin levels, and possibly reduce effectiveness of POPs.

Rationale: Broad-spectrum antibiotics such as ampicillin, erythromycin, and tetracycline have not been shown to decrease effectiveness of progestin-only oral contraceptives in careful clinical studies.

Rifampin/rifampicin, which is used primarily for treating tuberculosis, induces hepatic enzymes and increases the liver metabolism of progestins, thus decreasing the effectiveness of POPs. The enzyme-inducing effects of rifampin/rifampicin last about 4 weeks after short-term use and 8 weeks after long-term use.

Griseofulvin, an antifungal antibiotic and another hepatic enzyme inducer, has not been proven to reduce POP effectiveness in humans but may increase menstrual irregularities.

Rifampin/rifampicin is passed in breastmilk (milk:plasma ratio of 0.2 to 0.6). Griseofulvin may also be passed in breastmilk. Infant exposure to rifampin/rifampicin or griseofulvin is appropriate only when the maternal benefits outweigh the potential risks to the infant (16, 85, 93, 302, 329).

If a breastfeeding client is taking anticonvulsants?

Recommendation: Yes, usually. The common anticonvulsants hydantoins (e.g., phenytoin), barbiturates (e.g., phenobarbital, primidone), and probably carbamazepine significantly decrease the effectiveness of oral contraceptives. POPs are not recommended if using these enzyme-inducing anticonvulsants.

Additionally, because anticonvulsants are excreted in breastmilk, and because there is a potential for serious adverse reactions in nursing infants, women taking hydantoins, barbiturates, or carbamazepine for chronic seizure control may be advised to explore safe alternatives to breastfeeding.

Injectable contraceptives, such as Depo-Provera, will be effective despite anticonvulsant use, but infant exposure to the anticonvulsants will continue.

Nonhormonal methods will continue to be effective despite anticonvulsant use.

Rationale: The hepatic enzyme-inducing effects of most anticonvulsants probably decrease pregnancy protection and increase rates of irregular bleeding among some POP users. It should be noted, however, that POPs may decrease the probability of seizures among users of anticonvulsants.

Because of the dangers of fetal exposure to most anticonvulsants, full protection against pregnancy is essential. Although increased doses of POPs might be effective, they might also further increase bleeding irregularities (185).

If a woman ingests hydantoins, barbiturates, or carbamazepine, her breastmilk will contain significant quantities of these substances. In areas where safe alternatives to breastfeeding exist, and where maternal seizures cannot otherwise be controlled, women on long-term antiseizure medications may be advised to consider safe alternatives to breastfeeding to avoid chronic infant drug exposure (9, 302, 326).

If a breastfeeding client is taking antimalarial medication?

Recommendation: No back-up is needed. There is no evidence that antimalarial medications reduce the effectiveness of oral contraceptives.

Chloroquine and related antimalarials are excreted in breast milk.

Rationale: Chloroquine, primaquine, and tetracycline have not shown any effect on oral contraceptive hormonal levels and are not known to reduce the effectiveness of POPs.

A nursing infant may consume about half of a mother’s 300 mg chloroquine dose over 24 hours; the maternal milk: blood ratio may be about 0.36. Children are especially sensitive to chloroquine and primaquine.

Since the nutritional value of the milk to the child outweighs the effects of the chloroquine, clients are usually not advised to stop breastfeeding while on antimalarial treatment unless safe alternatives to breastmilk are available (91.

If it is a breastfeeding client’s first cycle of POPs?

Recommendation: No back-up is needed. However, if a breastfeeding woman has resumed menstruating and is beginning the pills later than the first 7 days of her cycle, some programs recommend that she use a back-up method for 7 days after beginning POPs.

Rationale: The cervical mucus thickens enough to prevent sperm penetration within 24 hours. Also, the synergistic protection against pregnancy conferred by concurrent POP use and breastfeeding should sufficiently eliminate a client’s risk of conception. Thus, a back-up method for a full 7 days may not be necessary (39, 148, 194).

If a breastfeeding client has missed pills?

Recommendation: If the breastfeeding woman is still amenorrheic, missed pills are of minimal consequence.

For a breastfeeding woman who has already returned to menses, if 2 or more pills are missed, the woman should:

* Resume taking a pill as soon as she remembers and the next one at the regular time that day (for added protection).

* Use a back-up method or abstinence for 48 hours (some programs recommend use of a back-up method for up to 7 days).

Rationale: after missing one pill, breastfeeding women previously taking POPs are estimated to be sufficiently subfertile that the probability of the woman becoming pregnant is extremely low.

The most immediate effect of POPs is on cervical mucus, each tablet offering protection for approximately 24 hours. Clinical trial data indicate that the pregnancy protection conferred by POP use during breastfeeding is high, indicating a synergistic pregnancy prevention effect for breastfeeding while using POPs. In addition, women in lactational amenorrhea have additional protection due to their lowered fecundity (14, 69, 148).

If a breastfeeding client has severe diarrhea and/or vomiting?

Recommendation: If a woman is breastfeeding and amenorrheic, no back-up method is needed since the synergistic effect of both breastfeeding and POP use should provide sufficient pregnancy protection.

If a breastfeeding woman has resumed menstruating, some programs recommend use of a back-up method for 48 hours or for 7 days after the severe vomiting or diarrhea stops.

Rationale: The synergistic protection conferred by POP use and breastfeeding should sufficiently eliminate a client’s risk of conception because women in lactational amenorrhea have additional protection due to their lowered fecundity (69, 147, 205).

Progestin-Only Injectables

This chapter covers the 3-month injectable contraceptive depot medroxyprogesterone acetate (DMPA), or Depo-Provera, and the 2-month injectable norethisterone enanthate (NET EN), or Noristerat.

Q.1. When can the first injection be given (interval)? How soon does it become effective? Is a back-up method needed?

Recommendation: Progestin-only injections may be given any time you can be reasonably sure the woman is not pregnant (see p. 33)–for example, during the 7 days which begin with the onset of menses (days 1 through 7 of the menstrual cycle).

Rationale: Although ovulation can occur as early as day 10 of the menstrual cycle, this is rare (234). Fertile ovulation is very uncommon before day 12 (269). Intercourse 5 days before ovulation may have as much as a 5% chance of resulting in pregnancy (66). However, since, experts believe, there are few fertile ovulations before day 13, there is only a very small chance that intercourse on day 7 of the cycle could result in pregnancy (269).

In general, use of DMPA within the first 7 days after the start of a woman’s normal menses would assure that the probability of the woman’s already being pregnant, or becoming pregnant, is extremely low (66, 104, 238, 269).

Although injectable progestins have no known teratogenic effects, avoiding the risk of fetal exposure is preferable on general principles. In addition, one study has suggested that in utero exposure may increase the risk of low birth weight (28,212,251).

Recommendation: For a woman having menstrual cycles, no back-up method is needed if she is in the first 7 days of her menstrual cycle and is still menstruating. If she is in the first 7 days of her cycle but is not menstruating, some programs may recommend use of a back-up method for 1 week. Injectables may be started any time you can be reasonably sure the woman is not pregnant (see p. 33). However, if injections are started after day 7 of a regular cycle, a back-up method (or abstinence) may be needed (see below).

Rationale: It is probable that progestin-only injections effectively thicken cervical mucus within 24 hours. Consistent with this theory, progestin-only pills have been shown to produce a thickened mucus with low sperm penetration within 3 to 4 hours after pill ingestion. Natural progesterone also causes cervical mucus to become scant, thick, and sticky, decreasing or inhibiting sperm penetration, usually within 24 hours but sometimes within 48 hours. Clinical judgment is also consistent with this theory (84, 126, 193, 270, 280, 316).

DMPA NET EN consistently inhibit ovulation (191,303).

Recommendation: Although there is good reason to believe the effect on cervical mucus will promptly provide contraceptive protection within 24 hours, it may be prudent to consider a back-up method for up to 7 days.

(See Question 2 for postpartum initiation and Question 3 for postabortion initiation.)

Rationale: Some programs might recommend a back-up method for women who are not menstruating at the time of progestin-only injectable initiation because there is a very slight risk of conception from unprotected intercourse on day 7 of the cycle.

Q.2. When can the first progestin-only injection be given postpartum?

For breastfeeding women

Recommendation: If the woman chooses to rely on the Lactational Amenorrhea Method (LAM), start injectable progestins when her menses(*) return, or when the woman is no longer fully or nearly fully breastfeeding, or at 6 months postpartum, whichever comes first (see p. 25).

Rationale: Risk of pregnancy during lactational amenorrhea is very low: less than 2% in the first 6 months postpartum if fully breastfeeding; less than or equal to 7% in the first 12 months. If the fully or nearly fully breastfeeding woman remains amenorrheic, her risk of pregnancy is about the same as her risk with other modern contraceptive methods (22, 147, 214).

Recommendation: If she does not want to rely on LAM, ideally wait at least 6 weeks postpartum to initiate injectable progestins.

Rationale: Based on animal studies and observed fluctuations of human sex hormones in the first 6 weeks of life, plus the immaturity of the neonatal liver for the metabolism of exogenous steroids, it is considered prudent to wait to initiate progestin-only contraceptives until a breastfeeding woman is at least 6 weeks postpartum (112, 289).

Studies have detected no clinically measurable effects on the health or growth of breastfed babies of women who begin using progestin-only injectables at 6 weeks postpartum (135, 213, 309, 311, 318).

For nonbreastfeeding women

Recommendation: The first progestin-only injection can be given immediately postpartum and whenever the service provider can be reasonably sure that the woman is not pregnant (see p. 33).

Rationale: While there may be a theoretical concern about increased thrombogenic effect with COC use in the first week postpartum, there is no known clinical thrombogenic effect of progestin-only contraceptives; therefore injectable progestins can be safely used immediately postpartum, for nonbreastfeeding women (36, 86, 303).

Q.3. Are progestin-only injectables appropriate for use immediately postabortion?

Recommendation: Yes, injectable progestins are appropriate for use immediately postabortion (spontaneous or induced) in any trimester and should be initiated within the first 7 days postabortion (or any time you can be reasonably sure the woman is not pregnant; see p. 33).

Rationale: Fertility returns almost immediately postabortion (spontaneous or induced): within 2 weeks for first-trimester abortion and within 4 weeks for second-trimester abortion. Within 6 weeks of abortion, 75% of women have ovulated (164, 206).

As noted above, there is no known clinical thrombogenic effect of progestin-only contraceptives; therefore injectable progestins can be safely used immediately postabortion (spontaneous or induced) (36, 86, 303).

Q.4. Are there any age/parity restrictions on progestin-only injectables?

Recommendation: No. However, young and/or childless women in particular need to understand that, on average, it takes a woman 4 months longer to become pregnant after discontinuing DMPA than after discontinuing COCs, IUDs, or barrier methods.

Rationale: After discontinuing DMPA, about 50% of women conceive by 7 months (i.e., 10 months after the last injection). This time delay to conception is approximately 4 months longer than the time it takes for women who discontinue COCs, IUDs, or barrier methods to conceive. Residual amounts of DMPA will remain in circulation for about 7 to 9 months after an injection, at which time serum levels of DMPA become undetectable. By about 2 to 3 years after discontinuation of DMPA, the proportion of women who have conceived is virtually the same as for those who have discontinued use of IUDs, diaphragms, and COCs. The delay in return to fertility with NET EN is presumed to be no more than with DMPA (21, 127, 191, 239, 303).

For older women

Recommendation: Injectable progestins may be used by women through menopause. Risks of use of injectable progestins appear minimal for older women.

Rationale: DMPA confers many noncontraceptive benefits including decreased menstrual blood loss as well as protection against endometriosis, acute pelvic inflammatory disease (PID), ectopic pregnancy, and, of particular importance to older women, protection against endometrial cancer. DMPA may also inhibit intravascular sickling–an additional benefit to women who have sickle cell disease. Other effects that may be attributed to DMPA use include a slight increase in weight and slight (not clinically significant) alterations in plasma lipid profiles. A theoretical risk of osteoporosis is currently under study (54, 55, 137, 177, 208, 247, 258, 270).

Because women greater than 35 years of age are at increasing risk for endometrial (and ovarian) cancer, it is particularly important to:

* Carefully evaluate irregular bleeding before administering the injectable and

* More carefully consider cancer as a possible cause if the woman returns with irregular bleeding after prolonged amenorrhea.

For adolescents

Recommendation: Use of progestin-only injectables generally leads to amenorrhea. Some evidence suggests that a hypoestrogenic state (as evidenced by amenorrhea) within the first 2 years after menarche may increase the risk of osteoporosis later in life, particularly for women with other risk factors for osteoporosis (e.g., women who are small-boned, underweight, white or Asian, smokers, or malnourished). However, for those adolescents age 15 and under for whom progestin-only injectables are the most appropriate method, the benefits of the method generally outweigh the risks.

Rationale: Amenorrhea while on progestin-only contraceptives is evidence of lower estrogen levels, and estrogen is necessary for the development and maintenance of strong bones (to prevent osteoporosis). The peak strength (density) of spinal bone is reached by girls around age 16; the greatest increase in bone density occurs in the first 2 years postmenarche.

Q.5. Is there a need for a rest period after a certain period of use of the progestin-only injectable, and is there a maximum recommended duration of use?

Recommendation: No, there is no need for a rest period. Injectable progestins may be used for as long as a woman wishes to avoid pregnancy.

Rationale: There is no cumulative effect of injectable progestins; the time required to clear the drug from the body is the same after multiple injections as after a single injection.

Q.6. Should the progestin-only injectable be discontinued because of extended amenorrhea?

Recommendation: No, there is no medical reason to discontinue. Emphasis should be on counseling, including reassurance that amenorrhea with injectable progestins is to be expected and is safe, as well as counseling on the benefits of amenorrhea.

Rationale: It is reasonable to expect amenorrhea among injectable progestin users, and the likelihood of amenorrhea increases with increased duration of progestin-only injectable use (50% at end of first year, two-thirds of women by the end of second year of use). Women who are counseled about this possible side effect will be less concerned if they experience extended amenorrhea.

Recommendation: The question of whether progestin-only injectables may be related to osteoporosis is under study. In theory, this may be a particular concern for older women with prolonged amenorrhea. (See Question 4 concerning amenorrhea due to DMPA before age 16.)

Rationale: Extended amenorrhea resulting from the use of injectable progestins is due to endometrial atrophy. There is no risk of endometrial hyperplasia. In fact, DMPA is protective against endometrial cancer.

Q.7. How much grace period is there for subsequent progestin-only injections?

Recommendation: For DMPA (150 mg) on a 3-month schedule, it is acceptable to give the next injection:

* Up to 2 weeks late and possibly up to 4 weeks late depending on the population, or

* Up to 4 weeks early, although this is not ideal.

Rationale: DMPA blood levels consistently remain high enough to maintain contraceptive effect through 3 months postinjection, and the pregnancy risk at 4 months postinjection is extremely low (and DMPA has no known teratogenic effects, although one study has suggested in utero DMPA exposure may increase risk of low birth weight).

Recommendation: For NET EN, on a 2-month schedule, it is acceptable to give the next injection:

* Up to 1 week late and possibly up to 2 weeks late depending on the population, or

* Up to 2 weeks early, although this is not ideal.

Rationale: For NET EN, blood levels remain high enough to maintain contraceptive effect through 74 days (2 months plus 2 weeks).

Recommendation: If a client comes in after the grace period, advise her that delays in obtaining progestin-only injections increase the risk of pregnancy and in utero exposure to the progestin-only injectable. It is acceptable to give the progestin-only injection if you can be reasonably sure she is not pregnant (see p. 33). Although there is good reason to believe the effect on cervical mucus will promptly provide contraceptive protection within 24 hours, it may be prudent to consider a back-up method for up to 7 days. Reschedule the next injection (for 3 months with DMPA or 2 months with NET EN).

Rationale: It has been shown that the time it takes for progestin levels to be insufficient for contraception may vary somewhat from population to population. Studies show that Thai women seem to metabolize DMPA rapidly. Additionally, weight has also been shown to have an independent influence on progestin levels (in heavier women the contraceptive effects last longer) (19, 87, 94, 304).

Q.8. If a woman complains of heavier menses and/or prolonged bleeding is there a medical basis for discontinuing progestin-only injections?

Recommendation: Not usually. Irregular and prolonged bleeding episodes are common and expected in the first 3 to 6 months of use.

For prolonged spotting or moderate bleeding (equivalent to normal menstruation but longer in duration), the first approach should be counseling and reassurance. It should be explained that in the absence of evidence for other diseases, irregular bleeding commonly occurs in the first few months of use of injectable progestins.

If counseling and reassurance are not sufficient for the woman and she wishes to continue the method, the following management approaches may be tried:

* Short-term (for 7 to 21 days) COCs or estrogen, or

* Ibuprofen (or similar nonsteroidal anti-inflammatories other than aspirin), or

* If the previous injection was given more than 4 weeks ago, giving another injection at this time may be an effective approach.

Rationale: The number of bleeding days decreases with months of injectable progestin use (24).

Recommendation: Heavy bleeding (greater than normal menstruation) is uncommon; it can usually be controlled by administration of increased doses of COCs (or estrogen). Some women will require stopping the use of injectable progestins due to medical reasons for excessive bleeding or due to the client’s preference.

If suspected, abnormal conditions that cause prolonged or heavy bleeding should be evaluated and treated as appropriate.

Some prolonged or heavy bleeding may fail to be corrected, and injections may need to be discontinued.

Evaluate and address anemia if indicated. Give nutritional advice on the need to increase the intake of iron-containing foods.

Do not perform uterine evacuation unless another medical condition is suspected. (Vacuum aspiration is generally the preferred method of uterine evacuation.)

Rationale: Management of prolonged or heavy bleeding may be achieved by:

* Rebuilding endometrium with COCs/estrogen, or

* Ibuprofen(*) (which blocks prostaglandin synthesis and thus decreases uterine bleeding) (61, 303, 312).

Q.9. Is an early second injection effective for controlling heavy bleeding?

Recommendation: It is not known. There is no clear evidence that a second DMPA injection (given 4 to 12 weeks after the first injection) offers measurable benefits for controlling heavy bleeding, but the existing studies are inadequate to address the question.

Rationale: One study found a decrease in the number of days of bleeding and/or spotting in women immediately following each re-injection every 12 weeks. Another study found no significant difference in the bleeding patterns of adolescents re-injected at 6 weeks compared with those re-injected at 12 weeks. However, there were several limitations to the studies, and more research is needed (111, 313).

Q.10. Can progestin-only injectables be safely initiated and resupplied only by doctors?

Recommendation: No. Injectable progestins (including immediate postpartum injection in nonlactating women and postabortion injection) also can be safely administered by other service providers (e.g., nurses, midwives, pharmacists, community-based distribution (CBD) workers, and others) who are appropriately trained according to relevant national or institutional standards.

Rationale: Nurses, midwives, and other community health workers can be appropriately trained to initiate and resupply injectable progestins (303).

Q.11. Should progestin-only injectables be provided if infection prevention measures cannot be followed?

Recommendation: No. All sites providing progestin-only injectable contraceptives should consistently follow basic infection-prevention measures, including:

* Cleaning of the injection site;

* Use of sterile needles and syringes (single use, disposable needles and syringes are preferred);

* If sterilization of reusable needles and syringes is impossible, decontamination with bleach followed by high-level disinfection–if correctly executed–may be used; and

* Safe disposal of single-use needles and syringes.

Rationale: Because injecting a steroid contraceptive, such as Depo-Provera, penetrates the protective skin barrier, careful infection-prevention technique must be followed. One type of infection associated with this procedure is an injection abscess, commonly caused by normal skin flora (staph and strep). Thorough skin preparation done before the progestin-only injection will remove most microorganisms from the client’s skin, which helps prevent cellulitis (skin infection) and abscess formation at the injection site.

Another concern is the increasing problem of transmission of hepatitis B and AIDS viruses to clients, health care providers, and clinic staff, especially cleaning and housekeeping personnel. To minimize this risk whenever possible single-use (disposable) needles and syringes should be used. If reusable needles and syringes are used, they should be decontaminated immediately after use by soaking in 0.5% chlorine solution or other locally available and approved disinfectant. These practices, when combined with the proper disposal of single-use needles and syringes, protect clinic staff, especially cleaning and housekeeping personnel, from contracting hepatitis B or AIDS following accidental needlesticks. Following decontamination, reusable needles and syringes should be thoroughly cleaned and finally, sterilized or high-level disinfected (272).

Q.12. What is the preferred site for a progestin-only injection?

Recommendation: Both the arm (deltoid) and the gluteal muscle are acceptable. The choice should be made by client preference. The progestin-only injection is deep intramuscular and should not be massaged.

Rationale: The deltoid is generally more acceptable to the client and more accessible for service providers (303).

Some providers prefer to offer NET EN in the gluteal muscle because the oil-based NET EN requires a larger-bore needle and may be painful.

Massaging the site of progestin-only injection increases immediate absorption. The objective of the depot formulation in oil is to achieve slow release over time.

Combined Injectable Contraceptives

The name of combined injectable contraceptives, or CICs, is given to a group of hormonal contraceptives administered by intramuscular injection. The term “combined” indicates that these injectables contain both a progestin and an estrogen. At present there are three main types of CICs on the market:

Progestin Natural Estrogen Brand Name

Depomedroxy-progesterone Estradiol cypionate Cyclofem 5 mg

acetate (DMPA)

25 mg

Norethisterone Estradiol valerate Mesigyna

enanthate 5 mg

(NET EN) 50 mg

Dihydroxy-progesterone Estradiol enanthate Deladroxate

acetophenide 150 mg 10 mg

Recommendation: Some women may not be able to tolerate heavy or prolonged bleeding and will discontinue CICs and need another method. Evaluate and address anemia if appropriate.

Do not perform uterine evacuation unless another medical condition is suspected. (Vacuum aspiration is always the preferred method of uterine evacuation.)

Q.4. Who can safely initiate and resupply CICs?

Recommendation: CICs (including immediate postpartum and postabortion injections) can be safely administered by appropriately trained service providers (e.g., nurses, midwives, pharmacists, CBD workers, and others), provided that infection-prevention measures can be assured.

Rationale: Nurses, midwives, and other community health workers can be appropriately trained to initiate and resupply injectables (303).

Recommendation: Under certain circumstances, clients may be provided with the supplies for self-administration or administration by another individual, provided that appropriate storage and infection-prevention procedures can be assured and that the woman knows where she can receive supportive services, should she have any problems.

Q.5. What is the recommendation for the once-a-month injectable contraceptive with 10 mg of estradiol enanthate and 150 mg of dihydroxyprogesterone acetophenide?

Recommendation: Use of the older injectable (10 mg of estradiol enanthate and 150 mg of dihydroxyprogesterone acetophenide) is not encouraged due to the availability of newer, lower-dose injectables (Mesigyna and Cyclofem). The newer CICs have theoretical advantages (lower estrogen dose) and more clinical trial data demonstrating their safety and efficacy.

However, some women may prefer the more reliable menstrual periods produced by the CIC with 10 mg of estradiol enanthate and 150 mg of dihydroxyprogesterone acetophenide (this “menstrual signal” can serve as a reminder for reinjection) or may otherwise have a personal preference. The older CIC may be made available since it may be an appropriate choice for some women.

Rationale: Both the older and newer CICs have very high efficacy. However, there is a theoretical concern of using 10 mg of estrogen monthly, because of the possible negative effects on blood coagulation. Newer CICs, such as Cyclofem and Mesigyna, have half the estrogen dosage of the older CICs. The lower-dose CICs have, at least theoretically, less risk.

In the first year of use, the CICs with 10 mg of estradiol enanthate and 150 mg of dihydroxyprogesterone acetophenide cause menstrual irregularities in an average 22.4% of users, with a range of 7.5% to 24.4%. However, 30% of users of Cyclofem and Mesigyna experienced menstrual irregularities within the first year. The incidence of menstruaI irregularities decreased with duration of use (152, 300).

Norplant Implants

Q.1. When can Norplant(*) implants be inserted (interval)? How soon after the insertion are Norplant implants effective? Is there a need for a back-up method?

Recommendation: Norplant implants may be inserted any time you can be reasonably sure the woman is not pregnant (see p. 33)–for example, during the 7 days that begin with the onset of menses (days 1 through 7 of the menstrual cycle).

Rationale: Blood levels of levonorgestrel rise to a level sufficient to prevent conception within 24 hours of insertion.

Although ovulation can occur as early as day 10 of the menstrual cycle, this is rare (238). Fertile ovulation is very uncommon before day 12 (269). Intercourse 5 days before ovulation may have as much as a 5% chance of resulting in pregnancy (66); however, since, experts believe, there are few fertile ovulations before day 13, there is only a very small chance that intercourse on day 7 of the cycle could result in pregnancy (269).

In general, use of Norplant implants within the first 7 days after the start of a woman’s Normal menses Would assure that the probability of the woman’s already being pregnant, or becoming pregnant, is extremely low (104).

Recommendation: For women having menstrual cycles, no back-up method is needed if she is in the first 7 days of her menstrual cycle and is still menstruating. If she is in the first 7 days of her cycle but is not menstruating, some programs may recommend use of a back-up method for 1 week. Norplant implants may be inserted any time you can be reasonably sure the woman is not pregnant (see p. 33). However, if insertion is done after day 7 of a regular cycle, a back-up method (or abstinence) may be needed (see below).

Rationale: It is probable that Norplant implants effectively thicken cervical mucus within 24 hours. Consistent with this theory, progestin-only pills have been shown to produce a thickened mucus with low sperm penetration within 3 to 4 hours after pill ingestion. Natural progesterone also causes cervical mucus to become scant, thick, and sticky, decreasing or inhibiting sperm penetration within 24 hours, but sometimes within 48 hours. Clinical judgment is also consistent with this theory (84, 126, 193, 270, 280, 316).

Recommendation: Although there is good reason to believe the effect on cervical mucus will promptly provide contraceptive protection within 24 hours, it may be prudent to consider a back-up method for up to 7 days.

Rationale: Some programs might recommend a back-up method for women who are not menstruating at the time of Norplant implant initiation because there is a very slight risk of conception from unprotected intercourse on day 7 of the cycle.

Q.2. When can Norplant implants be inserted postpartum?

For breastfeeding women

Recommendation: If the woman chooses to rely on the Lactational Amenorrhea Method (LAM), insert Norplant implants when her menses(*) return, or when the woman is no longer fully or nearly fully breastfeeding, or at 6 months postpartum, whichever comes first (see p. 25).

Rationale: Risk of pregnancy during lactational amenorrhea is very low: less than 2% in the first 6 months postpartum if fully breastfeeding; less than or equal to 7% in the first 12 months, if the fully or nearly fully breastfeeding woman remains amenorrheic, her risk of pregnancy is about the same as her risk with other modern contraceptive methods (22, 147, 214).

Recommendation: If the woman is fully breastfeeding but does not want to rely on LAM, ideally wait until at least 6 weeks postpartum to initiate Norplant implants. If she is only partially breastfeeding and does not want to rely on LAM, it is still advisable to wait at least until 6 weeks postpartum before initiating Norplant implants.

Rationale: Based on animal studies and observed fluctuations of human sex hormones in the first 6 weeks of life, plus the immaturity of the neonatal liver for the metabolism of exogenous steroids, it is considered prudent to wait to initiate progestin-only contraceptives until a breastfeeding woman is at least 6 weeks postpartum (112, 289).

Most studies 12, 63, 242, 309, 311) have not detected clinically measurable effects on the health or growth of breastfed babies of women who begin using Norplant implants after 6 weeks postpartum, although not all studies report consistent findings (62, 241). Based on current literature including studies with other progestin-only methods (135, 187, 309, 311), it is unlikely that there is a significant effect on growth of breastfeeding infants whose mothers initiate Norplant implants after the sixth postpartum week.

Recommendation: Programs that wish to give clients the option of Norplant implant insertion immediately postpartum should also give clients the option of returning after 6 weeks to receive Norplant implants.

Rationale: In some service delivery settings, access to Norplant implant insertion may be difficult for clients to obtain outside of immediate postpartum services.

For nonbreastfeeding women

Recommendation: Norplant implants can be inserted immediately postpartum and whenever you can be reasonably sure the woman is not pregnant (see p. 33).

Rationale: While there may be a theoretical concern of increased thrombogenic effect with COC use in the first week postpartum, there is no known clinical thrombogenic effect of progestin-only contraceptives; therefore Norplant implants can be safely inserted immediately postpartum, for nonbreastfeeding women (36, 86, 306).

Q.3. Are there any age/parity restrictions on Norplant implants?

Recommendation: No. Norplant implants may be used at any age at which the woman is at risk for pregnancy (e.g., past menarche and through menopause).

Rationale: See Progestin-Only Injectables, Question 4, p. 10, for considerations applicable to progestin-only methods.

Q.4. Is there need for a routine pre-exam (a separate visit) before insertion?

Recommendation: No.

* If possible, handle all counseling and screening on the same day as the insertion.

* A routine system of pre-exam visits is not necessary.

Rationale: There is no medical need for a pre-exam (separate visit); it may be difficult for a woman to make two visits, and she may be at risk of unintended pregnancy during this interval.

Q.5. What should the routine follow-up schedule be?

Recommendation: Encourage the client to call or return to her local provider if problems arise.

A visit within the first 1 to 3 months may be advised if additional counseling is necessary or to check the insertion site.

Inform the woman when removal will be necessary (in 5 years, or sooner if she desires) and provide her with a means of remembering this date.

Visits are encouraged for other preventive reproductive health care as available, including provision of condoms, when appropriate.

Rationale: The client should be encouraged to return to the clinic if she has any problems or questions, after 5 years, or when she desires removal, and for general reproductive health care. If women have no complaints, there is no need for routine contraceptive clinic visits before the end of the 5 years (72, 219, 332).

Q.6. If a woman complains of heavier menses and/or prolonged bleeding, is there a medical basis for removing Norplant implants?

Recommendation: Not usually. Irregular and even prolonged bleeding episodes are common and expected especially in the first 3 to 6 months of Norplant implant use.

For prolonged spotting or moderate bleeding (equivalent to normal menstruation but longer in duration), the first approach should be counseling and reassurance. It should be explained that in the absence of evidence for other diseases, irregular bleeding commonly occurs with Norplant implants.

If counseling and reassurance are not sufficient for the woman and the woman wishes to continue Norplant use, the following management approaches may be tried:

* Short-term (for 7 to 21 days) COCs or estrogen or

* Ibuprofen (or similar nonsteroidal anti-inflammatories other than aspirin).

Heavy bleeding (greater than normal menstruation) is rare with Norplant implants; it can usually be controlled by administration of increased doses of COCs or estrogen.

Rationale: Norplant implants may cause increased bleeding in some women and decreased bleeding in others. Changes in bleeding patterns tend to decrease over time (48, 219, 288).

Bleeding is managed by rebuilding the endometrium with COCs, or by taking ibuprofen(*) which blocks prostaglandin synthesis and thus decreases uterine contractions (COCs are preferred over estrogen because Norplant implants deliver such a low dose of progesterone that the contraceptive effect on the cervical mucus may be reduced by the addition of estrogen only) (61, 303).

Recommendation: If suspected, abnormal conditions that cause prolonged or heavy bleeding should be evaluated and treated as appropriate.

Some prolonged or heavy bleeding may fail to be corrected. Some women will require removal of Norp/ant implants due to medical reasons for excessive bleeding or due to client’s preference.

Evaluate and address anemia, as appropriate. Give nutritional advice on the need to increase the intake of iron-containing foods.

Do not perform uterine evacuation unless another medical condition is suspected. (Vacuum aspiration is generally the preferred method of uterine evacuation.)

Q.7. Can Norp/ant implants be safely inserted and removed only by doctors?

Recommendation: No. Norplant implants (including immediate postpartum and postabortion insertion) can also be safely inserted by other service providers (e.g., nurses, midwives, and others) who are appropriately trained according to national or institutional standards.

Rationale: Any specially trained doctor, nurse, midwife, or other health worker can perform Norplant insertions and removals (219).

Q.8. Should Norplant implants be provided if infection prevention measures cannot be followed?

Recommendation: No. All centers inserting and/or removing Norplant implants should follow basic infection prevention measures, including:

* Appropriate handwashing by the provider and thorough cleaning of the insertion site,

* Proper decontamination of reusable sharps and other instruments,

* Sterilization (or, at a minimum, high-level disinfection) of all equipment, and

* Safe disposal of contaminated sharps and other disposables.

Rationale: Although insertion and removal of Norplant implants are minor surgical procedures, careful infection precaution procedures, including good surgical technique, must be followed to prevent infections at the insertion site. Infection may result in early removal or spontaneous expulsion of a Norplant implant capsule.

Another concern is the increasing problem of transmission of hepatitis B and AIDS viruses to clients, health care providers, and clinic staff, especially cleaning personnel. To minimize this risk, blood-contaminated waste must be properly disposed of, and soiled instruments, gloves, and other items must be decontaminated, then thoroughly cleaned, and then sterilized or high-level disinfected after every use.

Sterilization (the destruction of all microorganisms, including endospores) is the preferred practice for processing instruments and other items that come in contact with the blood stream or touch tissue beneath the skin. When sterilization is not possible, high-level disinfection (which destroys all microorganisms except some endospores) is acceptable.

Regardless of which method (sterilization or high-level disinfection) is used for instruments and other items, thorough cleaning of the client’s arm and hand to remove soil and organic material is also necessary to prevent infection. Appropriate dressing and instruction to clients on hygiene of the insertion site are also important (272).

Q.9. What may happen if the Norplant implants are removed later than 5 years?

Recommendation: There is no risk from the Norplant implants themselves after 5 years. However, since the hormone levels released by Norplant implants decrease with time, Norplant implants do not prevent pregnancy as well after 5 years of use. Available evidence suggests that, as the rate of pregnancy increases, so will the rate of ectopic pregnancy. Because of the increased risk of pregnancy, current recommendations (which apply to all women regardless of weight or age) is that these implants be removed at the end of 5 years. Providers and women should be aware, however, that recent data suggest that, for women who weigh less than 60 kg and/or are over 30 years of age at implant insertion, good protection still exists in years 6 and 7 after placement, although the protection is somewhat less than that provided in the first 5 years. As stated above, there may be an increasing risk of intrauterine and ectopic pregnancy, but this risk tends to fall with age.

Some women may refuse to have their Norplant implants removed after 5 years. In such cases, women should be counseled on the potential risks (including ectopic pregnancy) and benefits. If she still refuses to have the removal she should be encouraged to use an additional method of contraception.

Rationale: Norplant implants are a very highly effective method of protection against pregnancies for up to 5 years after placement. The risk of ectopic pregnancy is also reduced (compared with use of no method). The blood levels of the hormone released by the implants decrease with time. Thus, it is assumed that pregnancy and ectopic pregnancy rates both will rise after 5 years. For these reasons, it is recommended that Norplant implants be removed after 5 years of use.

Recent data from a very large Chinese study clarify some of the issues. Women who weighed less than 60 kg and women over age 30 at implant insertion did not experience marked increases in pregnancy rates in years 6 and 7 of use as compared with rates in year 5, and the pregnancy rates were still quite low. A second, much smaller study in Chile found that the pregnancy rate during implant use increased to 4 per 100 woman years in years 6 through 8, but that no ectopic pregnancies occurred after the fifth year. These data perhaps suggest that although the blood levels of the drug are reduced after 5 years of use, this reduction is somewhat offset by the aging of the women, a factor that may principally affect women over the age of 30, who participated in the study.

Although the general recommendation to remove Norplant implants after 5 years pertains to all women, the Chinese and Chilean data suggest some leeway to organize and implement removal services at 5 years for populations where a large proportion of women weigh less than 60 kg or are over 35 years of age at the end of 5 years of implant use.

High priority should be placed on linking women who desire removal with providers trained with the skills necessary to perform such removals. However, if a woman does not want her Norplant implants removed, she should be informed of the risks and benefits associated with use of Norplant implants beyond 5 years, including decreasing effectiveness and the possibility of ectopic pregnancy. If she makes an informed decision to keep the Norplant implants, she should be encouraged to use an additional method of contraception and be advised about the signs and symptoms that occur with pregnancy or with ectopic pregnancy. She should further be advised to return to the clinic or facility at any time that she experiences signs or symptoms of a pregnancy or ectopic pregnancy (219, 331, 338, 354).

Q.10. What is the risk of an ectopic pregnancy while using Norplant implants?

Recommendation: The risk of ectopic pregnancy during the first 5 years of use is reduced compared with non contraceptive users since Norplant implants are a highly effective method of contraceptive protection. Although Norplant implants reduce the total number of ectopic pregnancies by decreasing the number of pregnancies, any pregnancies that do occur have an increased risk of being ectopic when compared with the risk of pregnancies being ectopic when using an alternative method of contraception.

Rationale: Because Norplant contraceptive implants provide a high level of protection against all pregnancies during the first 5 years, the number of ectopic pregnancies is reduced when compared with no contraceptive use. Data suggest that the ectopic pregnancy rate with Norplant implants is similar to the ectopic pregnancy rates for some very effective alternative methods such as female sterilization. However, the percentage of any pregnancies that do occur that are ectopic when using Norplant implants is somewhat higher than the percentage of pregnancies that are ectopic when using any other contraceptive method (219, 349, 357).

Q.11. Are Norplant implants less effective in heavier women?

Recommendation: Heavier weight does not appear to substantially diminish the effectiveness of soft-tubing Norplant implants. In contrast, Norplant implants made with older hard tubing (not manufactured since 1992) are less effective in women weighing more than 60 kg. However, these levels of effectiveness are acceptable to many women.

Rationale: Heavy women using hard-tubing Norplant implants experience a higher pregnancy risk than women using soft tubing because less hormone diffuses out through the hard tubing. Norplant implants made with hard tubing demonstrated a cumulative 5-year failure rate of 4.5% in women who weighed 60 to 69 kg. In contrast, Norplant implants made with soft tubing demonstrated a cumulative 5-year failure rate of 1.5% in women who weighed 60 to 69 kg. This difference between hard and soft tubing is more pronounced for heavier women. Women who weighed more than 70 kg had a 5-year cumulative failure rate of 9.3% for hard-tubing Norplant implants and 2.4% for soft tubing use.

Although recent data from China reported cumulative 5-year failure rates for hard tubing use that were lower than the failure rates reported above, an increased number of pregnancies was still associated with increasing weight–1.46 pregnancies (over 5 years) per 100 women weighing 50-59 kg, 2.08 pregnancies (over 5 years) per 100 women weighing 60-69 kg, and 4.58 pregnancies (over 5 years) for women weighing 70 kg or more.

Cumulative 5-Year Failure Rates for Norplant Implants

Pooled Data from Data from

Clinical Trials, 1988 China,1995

(254) (338)

User’s Soft Hard Hard

Weight Tubing Tubing Tubing

60-69 kg 1.5% 4.5% 2.08%

70 kg or more 2.4% 9.3% 4.58%

Rationale: Immediate insertions during cesarean sections by a properly trained provider have a lower expulsion rate than vaginal insertions immediately (within 10 minutes) after delivery. Studies also found that women with IUDs inserted at the time of cesarean section had longer continuation rates (317, 321).

Recommendation: If an IUD is not inserted at the time of the cesarean section, it is recommended that the IUD be inserted no earlier than 6 weeks after the cesarean section.

Rationale: Delayed postpartum insertions should take place no earlier than 6 weeks after cesarean section because of the risk of uterine perforation. Clients need careful assessment for presence of infection before insertion even at this time (189).

Q.4. Can an IUD be inserted immediately post-abortion?

Recommendation: Yes, the IUD may be inserted immediately postabortion (spontaneous or induced) if the uterus is not infected or during the first 7 days postabortion (or anytime you can be reasonably sure the woman is not pregnant; see p. 33).

Rationale: With appropriate technique, IUDs can be safely inserted postabortion (spontaneous or induced). Expulsion rates vary greatly depending on both the IUD type and provider. To minimize risk of expulsion, only providers with proper training (according to relevant national or institutional standards) and experience should insert IUDs. Clients should be carefully trained to detect expulsions.

Fertility returns almost immediately postabortion (spontaneous or induced): within 2 weeks for first-trimester abortion and within 4 weeks for second-trimester abortion. Within 6 weeks of abortion, 75% of women have ovulated (164).

Recommendation: IUDs should not be inserted in the following situations:

* With confirmed or presumptive diagnosis of infection (signs of unsafe or unclean induced abortion, signs and symptoms of sepsis or infection, or inability to rule out infection), do not insert an IUD until risk of infection has been ruled out or infection has fully resolved (approximately 3 months).

* With serious trauma to the genital tract (uterine perforation, serious vaginal or cervical trauma, chemical burns), do not insert an IUD until trauma has healed.

* With hemorrhage and severe anemia, IUDs (inert or copper-bearing) are not advised until hemorrhage or severe anemia is resolved. However, progestin-releasing IUDs can be used with severe anemia (they decrease menstrual blood loss).

* Postabortion IUD insertion after 16 weeks gestation requires special training of the provider for correct fundal placement. If this is not possible, delay insertion for 6 weeks.

Rationale: After 16 weeks gestation, the uterine cavity will be too enlarged for postabortion IUD placement to be accomplished by routine IUD insertion techniques. Only providers trained to do postpartum IUD insertion should perform immediate postabortion IUD insertion for postabortion clients after 16 weeks gestation (176, 221).

Q.5. What is an appropriate follow-up schedule after IUD insertion?

Recommendation: There should be one follow-up visit approximately 1 month after insertion; thereafter, there is no need for a fixed follow-up schedule.

The client should be strongly encouraged to come to the clinic any time she has questions or problems, particularly if she has:

* Late period (possible pregnancy),

* Prolonged or excessive abnormal spotting or bleeding,

* Abdominal pain or pain with intercourse,

* Infection exposure (such as gonorrhea), abnormal vaginal discharge, or pelvic pain especially with fever, or

* Strings missing or strings seem shorter or longer.

Visits are encouraged for other preventive reproductive health care as available, including provision of condoms, when appropriate.

Rationale: A follow-up visit at 3 to 6 weeks is prudent since the peak incidence of pelvic inflammatory disease (PID) post-IUD insertion is at 1 month. Thereafter, there is no need for a fixed follow-up schedule. The best quality of care is to focus clinic resources and attention on those women who come back to the clinic with complaints or problems (76, 131).

Q.6. Is there a need for a routine pre-exam (a separate visit) before IUD insertion?

Recommendation: No. If at all possible, handle all counseling and screening on the same day as the insertion.

Rationale: There is no medical need for a pre-exam (separate visit); it may be difficult for a woman to make two visits, and she may be at risk of pregnancy during this interval.

Q.7. Should young, nulliparous women receive IUDs?

Recommendation: An IUD may be provided to young, nulliparous women only after careful and thorough consideration. An IUD is only recommended for young, nulliparous women if they are living in a stable, mutually faithful relationship.

To receive IUDs, women should not be at increased risk of STDs. Counseling should focus on the risk of STDs, PID, and the possible risk of resulting infertility.

Rationale: Young women statistically have a higher risk of PID. IUDs, in contrast to all other modern contraceptive methods, increase the risk of PID when a woman is infected with an STD. PID is a major risk factor of tubal infertility and ectopic pregnancies. Because young women may have patterns of sexual activity that lead to STD risk, the relative risk of PID in young IUD users may be high. Additionally, nulliparous women receiving IUDs may be at higher risk for expulsion.

The degree to which client values future fertility is an important factor in the choice of a contraceptive method. Studies have shown that the risk of PID and subsequent tubal-factor infertility is directly proportional to the risk of exposure to sexually transmitted disease. IUDs do not protect women against PID or other STDs.

Nevertheless, women should be allowed to make their own choice (7, 181, 215, 313).

Q.8. Are there medical reasons for removal of an IUD?

Recommendation: IUD removal is indicated if:

* The woman requests removal,

* The woman develops precautions/contraindications, or

* The effective life of the IUD is reached.

Rationale: The removal and reinsertion of an IUD exposes a woman to a small risk of introduction of vaginal or endocervical canal microorganisms into the upper genital tract. For this reason, long-acting IUDs are preferred. The copper T 380A has been shown to be effective for at least 10 years (76, 151, 218).

Q.9. Following removal of an IUD (for reasons of partial expulsion without infection, or expiration of the IUD), should one wait to insert another?

Recommendation: If the client wants to continue the method, do not wait to reinsert a new IUD after old IUD removal, provided pregnancy has been ruled out and no new precautions/contraindications have developed.

Make sure removal of the first IUD is indicated (i.e., for reasons of partial expulsion without infection or expiration of the IUD).

Rationale: Even with proper technique, the removal and reinsertion of an IUD expose a woman to the risk of introduction of vaginal and endocervical canal microorganisms into the upper genital tract. Therefore, removal and insertion at the same time avoid two separate exposures (76).

In an interval between removal of one IUD and insertion of another, the woman will not be protected against pregnancy by the method of her choice.

Q.10. If a woman is at low risk of STDs based on history, may IUDs be inserted without any lab tests if there is no mucopurulent endocervical discharge or clinically apparent PID or cervicitis?

Recommendation: Yes, if the woman has no current risk factors for STDs (by history and on exam) and she has no apparent clinical signs or symptoms of infection (including normal bimanual exam).

If PID, mucopurulent endocervical discharge, cervicitis, or clinically apparent vaginitis is present, do not insert an IUD but treat for infection. Consider other contraceptive methods, if an STD(*) is suspected.

Rationale: Currently available lab tests may be impractical and often unaffordable (even in the developed world) to rule out endocervical colonization by infectious agents capable of ascending and causing PID. Most chlamydia tests are only 80% to 90% sensitive, tests for mycoplasma and ureaplasma are not routinely available, and cervical gram stain is less sensitive for gonorrhea. However, where gonorrhea culture and chlamydia tests are affordable, negative test results provide reassurance to corroborate the woman’s history (21, 154, 198).

Q.11. How much time should elapse between STD treatment and insertion? What about previous STD incidence?

Recommendation: If the client will not be at high risk of an STD in the future, treat the STD today and insert the IUD when the infection is resolved (for acute PID, wait 3 months).

If she remains at increased risk of PID, advise against IUD use.

Rationale: PID may take several weeks to resolve clinically, and, in the case of severe PID, waiting several months in theory allows healthy tissues (free of micro-abscesses) to form (267).

Women with prior PID are at increased risk of repeat PID. A woman who has had an episode of upper reproductive tract infection may be at increased risk of repeat episodes of nonsexually transmitted PID regardless of IUD use. Theoretically, a previous episode of upper reproductive tract infection may result in tubal damage increasing susceptibility of the fallopian tubes to opportunistic lower genital tract flora (139, 294).

Q.12. If a woman complains of heavier menses or bleeding between menses, is there a medical basis for removing the IUD?

Recommendation: Not necessarily. As in premethod choice counseling, women should be informed that menses are normally heavier with the IUD and intermenstrual bleeding may occur, especially in the first few months. Inert IUDs should not be the first choice, for this reason.

Give nutritional advice on the need to increase the intake of iron-containing foods.

Rationale: In general, IUDs (especially inert IUDs) commonly increase the amount of menstrual blood loss, varying according to IUD type, particularly in the first few months postinsertion (42).

Copper IUDs may increase normal menstrual blood loss by 50%, which may be clinically significant for women who are already anemic. (Progestin-releasing IUDs decrease menstrual blood loss; the more progestin an IUD releases, the more effectively it decreases menstrual blood loss.) (69)

Recommendation: For mild to moderate bleeding and pain in the first month postinsertion, with no evidence of clinically apparent pelvic infection, and if reassurance is not sufficient but the woman wants to keep the IUD, a short course of a nonsteroidal anti-inflammatory agent other than aspirin (e.g., ibuprofen) may be given.

Rationale: Nonsteroidal anti-inflammatory drugs (e.g., ibuprofen(*)) decrease uterine bleeding and cramping (9).

Recommendation: Bleeding generally decreases over time. If bleeding is heavy or the woman is anemic, treatment with oral iron can improve hemoglobin levels.

If bleeding or pain is severe, or the client wishes to discontinue use, remove the IUD.

If suspected, abnormal conditions that cause prolonged or heavy bleeding should be evaluated end treated as appropriate.

If pelvic infection is diagnosed, remove the IUD and treat with antibiotics. (In the case of mild uterine tenderness without any other evidence of pelvic infection, broad-spectrum antibiotics or chemotherapeutics may solve the problem; use clinical judgment regarding whether or not to remove the IUD).

Q.13. Can IUDs be safely inserted by trained nurses and midwives?

Recommendation: Yes, IUDs (including immediate postpartum, postcesarean, and postabortion insertion) can be safely inserted by nurses and midwives who are appropriately trained according to relevant national or institutional standards.

Rationale: Nurses and midwives have been shown to have equal or superior competence in IUD insertion when compared with doctors (73).

Q.14. Should IUDs be provided if infection-prevention measures cannot be followed?

Recommendation: No. All sites inserting and/or removing IUDs should follow basic infection prevention measures, including:

* Appropriate handwashing by the provider and careful preparation of the cervix,

* Sterile (or high-level disinfected) IUDs and equipment, Correct decontamination of instruments, and

* Safe disposal of contaminated disposables.

Rationale: The potential for infection in IUD users is increased in areas where genital tract infections (GTIs) such as gonorrhea and chlamydia are prevalent. By following recommended infection-prevention processes, however, health workers can minimize the risk of post-IUD insertion infection to clients and the danger of transmitting infections, even hepatitis B or AIDS, to their clients, their co-workers, or themselves (272).

Sterilization is the safest and most effective method for processing instruments that come in contact with the bloodstream, tissue beneath the skin, or tissues that are normally sterile. When sterilization equipment is either not available or not suitable, high-level disinfection (HLD) is the only acceptable alternative. HLD destroys all microorganisms, including viruses causing hepatitis B and AIDS, but it does not reliably kill all bacterial endospores. For example, in family planning facilities, either sterilization or HLD is acceptable for processing instruments and gloves used for pelvic exams and IUD insertion and removal, since problems with endospores (Clostridia species) have not been reported with IUD use. Regardless of the method selected, however, HLD can only be effective when used (soiled) instruments and gloves are first decontaminated, thoroughly cleaned, and rinsed before disinfection (272).

Contaminated wastes may carry high loads of microorganisms that are potentially infectious to any persons who contact or handle the waste. Incineration provides high temperatures and destroys microorganisms; therefore it is the best method for disposal of contaminated wastes. Incineration also reduces the bulk size of wastes to be buried. If incineration is not possible, all contaminated wastes must be buried to prevent scattering the waste materials (272).

Q.15. Is it advisable to routinely give prophylactic antibiotics for IUD insertion?

Recommendation: No, most authorities do not routinely recommend it, because there is no clear evidence that prophylactic antibiotics definitely prevent pelvic inflammatory disease (PID) in IUD users and the studies so far have found only a trivial impact on PID rates due to prophylactic antibiotics. However, opinions differ, and there are arguments to support both sides.

There is a theoretical rationale for the practice of giving prophylactic antibiotics. PID rates in IUD users are highest in the first few weeks, and antibiotics could reduce those PID rates. While there is no statistically significant proof for reduction in PID rates, one study found a lower rate of IUD-related unplanned returns to the clinic.

Arguments against the use of prophylactic antibiotics include the insignificant impact of antibiotics on reducing the PID rates in IUD users demonstrated in previous studies. Also, although the rate of PID in IUD users is highest in the first few weeks after insertion, due to the long duration of use of IUDs the greatest numbers of PID cases will occur after the first few weeks after insertion. In addition, there is some concern about the programmatic feasibility and cost of prophylactic antibiotics.

Good infection control procedures, proper assessment of the client’s risk for STDs, and proper insertions are very important to keep the rate of PID low in IUD clients.

Rationale: The scientific literature does not show any large reduction in PID rates by giving prophylactic antibiotics for IUD insertion (76, 160, 252, 287, 324). However, in each of the studies, infection-prevention procedures were followed, and the rates of PID were very low. Also, the sample sizes in the studies were small.

Although the differences were not statistically significant, three studies ail showed some reduction in the PID rate in women given prophylactic antibiotics.

Sinei et al. found that the PID rates for the first month after IUD insertion in women who were given doxycycline was 1.3% compared with 1.9% in the women who received a placebo. They also found that the women who received a placebo returned to the clinic for IUD-related problems that were suggestive of subclinical PID more often than the treated women (252).

Zorlu et al. found infection rates to be 2.1% and 2.9% in doxycycline-treated and untreated women, respectively, within the first 3 months after IUD insertion (325).

Walsh et al. found that within the first 3 months after IUD insertion, 3.6% of the doxycycline group had the IUD removed for medical reasons compared with 4.5% of the placebo group (287).

Q.16. If the cervix is red due to eversion of the squamo-columnar junction (ectopy/ectropion), may the IUD be inserted without further investigation?

Recommendation: Yes, the IUD may be inserted for clients with cervical ectopy/ectropion, if not at risk of STDs and the pelvic exam is normal (no cervicitis).

Rationale: Cervical ectropion (the presence on the ectocervix of columnar epithelial cells from the endocervix) is a normal condition in adolescents and in pregnancy, and is distinct from cervical infection (209).

IUD insertions and continued use of the IUD have no relation to risk of cervical carcinoma (170).

Since chlamydia is an intracellular parasite of columnar epithelial cells, women with ectropion may be more likely to have positive chlamydia tests (113).

Female Sterilization (Tubal Occlusion)

Q.1. When can female sterilization be performed?

Interval?

Recommendation: Female sterilization can be performed any time you are reasonably sure a woman is not pregnant (see p. 33), for example, during the 7 days which begin with the onset of menses (days 1 through 7 of the menstrual cycle).

Rationale: Pregnancy is considered a category D (delay the procedure until the condition is corrected) by the WHO for performing female sterilization. While medical contraindications do not exist for performing a female sterilization during early pregnancy, the perception is that the sterilization procedure has failed. Clients should be refused sterilization if an early pregnancy cannot be ruled out (302).

Early postpartum?

Recommendation: Sterilization can be performed preferably within the first 7 days postpartum.

The procedure should be delayed in the presence of certain conditions (see WHO Eligibility Criteria). (See pp. 41-48).

Late postpartum?

Sterilization can also be performed postpartum once the uterus is fully involuted.

Postcesarean section?

Female sterilization can be performed at the same time as a cesarean section, or within 7 days post cesarean, as long as the woman is stable.

The procedure should be delayed in the presence of certain conditions (see WHO Eligibility Criteria). (See pp. 41 -48).

Sterilization can also be performed postpartum once the uterus is fully involuted.

Postabortion?

Sterilization can be performed concurrently with a medically safe induced abortion or within 7 days postabortion, if you are sure the woman is free of infection.

In the context of postabortion care, where it is possible that an unsafe abortion has occurred, female sterilization should not be performed unless the provider is sure the woman is free from infection.

Rationale: From the surgical perspective, minilaparotomy performed within 48 hours after vaginal or cesarean delivery is easier than and as safe and effective as interval sterilization. Because the uterus is enlarged immediately postpartum, the fallopian tubes are nearer the abdominal wall and can be reached easily during the first 48 hours after delivery. Approximately 2 days postpartum the uterus begins to involute and by 2 weeks is within the true pelvis. Thus, after 48 hours postpartum, more care is required if sterilization is to be performed since the uterus becomes less accessible from the subumbilical incision and its position in the abdomen may be difficult to ascertain. The uterus is still accessible for up to 7 days but may require a slightly lower incision (49, 314).

It has been recent practice to avoid doing postpartum female sterilization after 48 hours because of a concern about increased infection. Because bacteria are present in the endometrial cavity and fallopian tubes, prophylactic antibiotics are recommended when female sterilization is performed beyond postpartum day 3 (169).

Severe pre-eclampsia/eclampsia, premature rupture of membranes, sepsis or indication of infection, severe hemorrhage, and severe trauma to the genital tract or uterine rupture or perforation are contraindications to female sterilization, and the procedure should be delayed until the condition is resolved (302).

The uterus is usually fully involuted 4 weeks after delivery, although it may take 6 weeks or longer in some cases. For women who are not breastfeeding and are therefore at some risk of pregnancy before 6 weeks, if the uterus is fully involuted female sterilization at 4 weeks postpartum can be safely provided. If the uterus is not fully involuted, this may be a sign of infection or incomplete resolution of postpartum healing, and female sterilization should be delayed (121).

In the absence of complications, female sterilization can be performed at the same time as the abortion (302).

If the woman intends to breastfeed her infant, local anesthesia is preferred over general anesthesia to minimize interruption of the early breastfeeding pattern and infant exposure to the anesthetic agent.

General anesthesia may effect lactation by delaying the start of breastfeeding while the mother recuperates from the anesthesia and by hampering the infant’s attempts to feed if the infant has ingested some of the anesthetic agent in the milk. The negative effect is more pronounced when the sterilization is not performed immediately after delivery (142, 143).

Q.2. Are there any medical restrictions based on client’s age or number of living children for women to undergo female sterilization?

Recommendation: No. In terms of safety, there are no age and parity medical restrictions for women to have sterilization, but age and parity must be considered during the counseling process to minimize the potential for regret.

Rationale: Age at time of sterilization has been found to be a risk factor for regret in both women and men. Wilcox et al., in a prospective study based on 7,590 US women followed up for 5 years, found that women under 30 years of age at sterilization were 2 to 3 times more likely to report regret than those sterilized between 30 and 35. This effect was independent of number of living children or marital status at the time of sterilization (295). Young age has also been found to be a major factor in other US studies and in studies of women in Canada and Puerto Rico (26, 116, 182).

Parity has often been discussed as a risk factor for regret in women. Several major studies have not found parity to be a significant predictor of regret. However, some experts suspect that parity may still be an important predictor of regret in some cultures (26, 116, 171, 182, 217, 295).

Q.3. Should there be a required waiting time before female sterilization for a woman who has been counseled and has chosen female sterilization?

Recommendation: No. If a woman has been counseled and has chosen female sterilization, no waiting time should be required.

However, if it does not pose a barrier to access and the woman is using another contraceptive method so that she is not at risk of pregnancy, it is often beneficial for the woman to have time to think about her decision.

For cases associated with delivery (postvaginal delivery, postpartum, or concurrent with cesarean section), it is recommended that counseling occur well in advance of delivery, wherever possible, to minimize the chances of regret following the decision. If counseling cannot be provided in the antenatal period, it may be provided in the immediate postpartum period once the woman is past the major stress of labor and delivery and has no residual effects of anesthesia or sedatives.

Rationale: For postpartum minilaparotomy, counseling should take place well in advance of delivery, at a time when the woman is under minimal stress. During counseling, the woman should be told that if she changes her mind or if the condition of the baby is unstable, she can choose not to have the sterilization after giving birth. If she will give birth away from the hospital, she should be counseled that she must come to the hospital within 7 days (preferably within 48 hours) or wait until at least 4 to 6 weeks after delivery for an interval procedure. If family planning counseling has not been provided during the antepartum period, it should be included in postpartum services (199).

Q.4. Does post-female-sterilization syndrome exist?

Recommendation: No, based on the weight of the evidence. The existence of post-female-sterilization syndrome, in which women report having menstrual changes following female sterilization, has not been confirmed in large studies.

The changes reported by these women seem to be related to aging or stopping the use of oral contraceptives, not to the procedure.

Rationale: For many years there has been controversy over whether or not a “post-female-sterilization syndrome” truly exists. The varying definitions of post-female-sterilization syndrome usually refer to menstrual symptoms such as dysmenorrhea, heavy bleeding, or spotting, and changes in cycle length or regularity. It has also been suggested that methods of occlusion resulting in more extensive damage to the fallopian tubes and mesosalpinx may be more likely to cause subsequent changes in menstrual function.

Some criticism faulted early studies on menstrual irregularities following sterilization for a failure to account for other factors leading to a change in menstrual function following sterilization such as presterilization use of oral contraceptives possibly masking underlying menstrual dysfunction. Recent prospective studies that accounted for these confounding factors have failed to find a significant difference in the change in menstrual function between sterilized and nonsterilized women over time.

Most studies of menstrual change following sterilization have had periods of follow-up for 1 to 2 years and have found no increase in risk of menstrual change. Studies with follow-up periods longer than 1 year have been inconsistent in their findings (56, 234).

Studies looking at laboratory determinations of hormone levels as a possible mechanism for the post-female-sterilization syndrome have yielded little useful information. Many studies compare women undergoing sterilization with controls but do not measure the subjects’ hormone levels preoperatively. Studies that did measure such levels preoperatively found no changes following sterilization (but these studies involved small numbers of women) (3, 95, 226).

Q.5. What is the long-term risk of pregnancy following female sterilization?

Recommendation: The cumulative probability of becoming pregnant in 10 years is estimated to be 0.8% following partial removal of the tubes postpartum, and 2.0% following interval sterilization, respectively (based on US data).

Female sterilization is the most effective long-term family planning method other than vasectomy. Female sterilization is particularly effective when performed by partial removal of the tube, as with minilaparotomy, either:

* Immediately postpartum, or

* At 6 or more weeks after delivery (interval sterilization).

In general, women sterilized at young ages have higher failure rates than women sterilized at older ages.

Rationale: Female sterilization is the only permanent female family planning method. Annual pregnancy rates for minilaparotomy using partial salpingectomy, commonly the Pomeroy and Parkland techniques, are very low, but when failure occurs, it is most often in the first or second years after surgery. Rarely do pregnancies occur after 5 years.

The best data come from a long-term US study (216). This study reports that the cumulative pregnancy rates during the first 5 years and for years 6 through 10 per 100 women are:

* For postpartum partial salpingectomy, 0.6 and 0.1 per 100 women, respectively;

* For laparoscopic silicone bands, 1.0 and 0.8. For interval partial salpingectomy, the study does not have good, unbiased data. However, it may be reasonable to estimate the rates for interval partial salpingectomy as similar to the postpartum rates because studies in the past have demonstrated the interval procedure to be as or more effective than the postpartum procedure.

Experts assume that the extremely low pregnancy rates in years 6 through 10 will continue through years 11-20, which is very important for women wanting no more children. Because pregnancies are rare events following female sterilization, accurate pregnancy rates are difficult to determine from international data sources such as the Demographic and Health Surveys (DHS) and therefore are not routinely reported with pregnancy rates for other methods (196, 216, 301).

Recommendation: The 10-year cumulative pregnancy rate is 1.8% for tubal sterilization by laparoscopy using silicone bands.

Silicone bands are the most common laparoscopic female sterilization method outside North America and Western Europe. Female sterilization by laparoscopy using silicone bands is equally effective as interval minilaparotomy techniques.

Rationale: Laparoscopic female sterilization by spring clip and bipolar electrocoagulation result in higher cumulative 10-year pregnancy rates, 3.7 and 2.5 per 100 women, respectively (whereas the 10-year pregnancy rate for a postpartum partial salpingectomy is 0.8 per 100 women). However, these laparoscopic occlusion techniques are used infrequently outside North America and Western Europe (216).

Recommendation: The 10-year cumulative ectopic pregnancy rate is 0.73% for all methods of tubal sterilization combined.

Rationale: The 10-year cumulative ectopic pregnancy rates were higher in women who were younger than 30 at the time of the sterilization compared with women who were 30 or older at the time of the procedure, and in women who were sterilized by bipolar coagulation compared with women sterilized by any other method (349).

Q.6. Who can provide female sterilization?

Recommendation: Female sterilization can be provided by any health professional who has been appropriately trained to perform a minilaparotomy (interval or postpartum). Minilaparotomy can be successfully performed by properly trained doctors, medical officers, nurses, nurse-midwives, and other health personnel with surgical experience.

Rationale: Various types of doctors, including general medical practitioners, general surgeons, and other specialists (such as obstetrician-gynecologists), can receive training to perform minilaparotomy, as can paramedical professionals (such as midwives) who routinely perform surgery in a country. It is important that candidates selected for training be interested in and supportive of voluntary sterilization as a family planning choice. In addition, trainees who have demonstrated their surgical ability and who have prior experience in abdominal surgery are suitable to be trained in minilaparotomy and management of surgical complications. Those with no or minimal previous abdominal surgery experience may be safely trained to competently perform minilaparotomy in settings where surgical backup is available on site or by referral (13, 299).

Q.7. What is the appropriate follow-up schedule after female sterilization?

Recommendation: One follow-up visit 7 days following sterilization or within 2 weeks is strongly recommended to check on the healing of the wound and to remove any sutures.

The woman should be encouraged to come back promptly if she has any problems (such as fever, pain, bleeding, or pus) or at any time if she has questions or concerns.

Rationale: The follow-up examination should take place between 7 and 14 days after surgery. If nonabsorbable sutures were used, removal after 7 days increases the risk of infection (301).

There is no medical benefit to routine long-term follow-up, although women should be encouraged to seek medical care for general health reasons. In addition, women should receive counseling on warning signs that would necessitate a return to the provider.

Q.8. Should female sterilization be considered permanent?

Recommendation: Yes. Although there are procedures to reverse a female sterilization, the operation is complex and expensive and the success rate depends on several factors (such as the surgeon’s experience with the reversal procedure, age of the client, the type of sterilization the client received, average tubal length, and site of anastomosis).

Although some studies have reported high success rates, the live birth rates are lower than the “success” rates reported because “success” is often defined as an intrauterine pregnancy and includes both births and miscarriages. Only a small fraction of the total number of women who request reversal are likely to have a successful reversal procedure.

Rationale: Reversing sterilization is a complex and expensive procedure (68, 232).

Rouzi et al. found that age and average tubal length were significant factors in predicting success of sterilization reversals (233). Other predictive factors are the type of sterilization procedure and surgeon’s experience.

Siegler et al. reviewed the literature and found that, although the overall pregnancy rate from seven studies was 67.7%, the live birth rate was only 54.4% (250). Glock et al. looked at sterilization reversals in women over 40 and found a live birth rate of 14.3% and a spontaneous abortion rate of 23.8% (99).

Vasectomy

Q.1. Are there any medical restrictions by client’s age, number of living children or required waiting time for a man to undergo vasectomy?

Age? Number of living children?

Recommendation: No. In terms of safety, there are no age or number of living children medical restrictions for men to have sterilization, but both must be considered during the counseling process to minimize the potential for regret. While the client’s wishes should be paramount, he should understand that young age is a risk factor for regret.

Waiting time?

Recommendation: No. If a man has been counseled and has chosen a vasectomy, no waiting time should be required. However, it is often beneficial for the man to have time to think about his decision.

However, the incidence of regret even with young age at time of vasectomy remains low. Counseling is important to minimize the potential for regret.

Rationale: Age and number of living children are not medical reasons to restrict access to vasectomy according to WHO Medical Eligibility Criteria (302). However, age and number of living children are important considerations for the counseling process. Clarke and Gregson found that men who requested vasectomy reversal were younger at the time of sterilization than controls (41).

Other factors that have been associated with vasectomy regret are remarriage or a change in partner, death of one or more children after the procedure, improvement in financial I status, and, more rarely, psychological problems with infertility or other physical problems. However, vasectomy has not been shown to physically cause adverse health effects (see Question 5) (178).

Q.2. Who can provide vasectomies?

Recommendation: Vasectomies can be provided by any health professional who has been properly trained to perform a vasectomy. Properly trained doctors, medical officers, nurses, nurse-midwives, and other medical personnel with surgical experience can successfully perform vasectomies.

Rationale: Various types of doctors, including general medical practitioners, general surgeons, other specialists (such as obstetrician-gynecologists), and paramedical professionals can receive training to perform vasectomy (14).

Q.3. Are back-up contraceptive methods necessary after a vasectomy?

Recommendation: Yes. Although a man may have intercourse 2 or 3 days after the procedure if it is comfortable, a vasectomy is not immediately effective. The recommendations are for back-up methods to be used for 12 weeks following vasectomy or at least 20 ejaculations. Where programmatically feasible, a semen analysis should be performed at that time to check that the semen no longer contains sperm.

It is important to recognize that a vasectomized man may still be at risk of acquiring or transmitting STDs and may need to use a back-up method (e.g., condom) to protect himself and his partner(s).

Rationale: It may take several months for the vas to clear the sperm contained in them at the time of vasectomy. This time varies from man to man. Therefore a back-up method for pregnancy prevention (e.g., condoms, DMPA for partner) will need to be used for at least 12 weeks or 20 ejaculations (30).

Q.4. What is the appropriate follow-up schedule following a vasectomy?

Recommendation: Follow-up with in 7 days ar at least within 2 weeks is strongly recommended to check sites of incision, remove any stitches, and look for signs of any complications. If feasible, a semen analysis can be performed after 20 ejaculations or 12 weeks to verify that azoospermia has been achieved.

The client should be encouraged to return promptly if he has any problems (e.g., bleeding, swelling, fever, pain) or at any time he has questions or concerns.

Rationale: The follow-up examination should take place between 7 and 14 days after surgery. Clients should receive counseling on warning signs and reasons to return for follow-up.

Q.5. Does vasectomy cause adverse long-term health effects?

Recommendation: No, based on the weight of available evidence. Studies have not been conclusive as to a possible increased risk of prostate cancer. Although several studies found no association, two studies found a slight increase in risk.

A large study also found no association between vasectomy and other health effects including cardiovascular disease.

Rationale: Based on biological and epidemiological evidence, it is unlikely that vasectomy causes prostate cancer or any other long-term health effects such as cardiovascular disease.

A recent study and two earlier studies also examined the association between vasectomy and prostate cancer. Zhu et al. used a population-based case-control design in a population where vasectomy was common (323). No association was found. Massey et al. and Sidney et al. both used a cohort study design. The former used a retrospective cohort of 10,590 vasectomized men (184), while the latter used a prospective cohort with a mean follow-up period of 6.8 years among 5,119 vasectomized men (249). Neither study found an association between prostate cancer and vasectomy. Giovannucci et al. found odds ratios of 1.56 and 1.66, respectively, in two separate cohort studies (96,97). However, the biological explanation for the association has not been accepted by experts as likely (96, 97, 115, 184, 249, 322).

Recommendation: Vasectomy does not affect normal sexual function. After a vasectomy, the man’s body continues to produce male hormones that help the man to have erections, sex drive/feeling, and ejaculation. A man may even feel his sex drive is increased because he no longer worries about getting his partner pregnant.

Rationale: Vasectomy only involves the occlusion of two small ducts, not the removal of any glands or organs. Therefore, it does not interfere with the functions of the testes–testosterone production and spermatogenesis (60).

Q.6. Should a vasectomy be considered permanent?

Recommendation: Yes. Although there are procedures to reverse a vasectomy, the operation is very complex and expensive and the success rate depends on several factors such as type of reversal procedure, the physician’s experience with the reversal procedure, time since the vasectomy was performed, the client’s sperm quality and quantity, the anatomical effects of the original vasectomy, the presence of sperm antibodies, and the client’s partner’s fertility.

Although reports have found sperm in the ejaculate in more than 67% of the men who had undergone vasectomy reversal, the percent of successes, as measured by pregnancies among their partners, ranged from 16% to 85%, with over half of the studies reporting that less than 50% of the wives achieved intrauterine pregnancy.

Rationale: A vasectomy reversal is an extremely complex operation that should be performed by highly trained and experienced surgeons. Microsurgical techniques require approximately 40 hours of intensive training in addition to frequent practice before a surgeon is proficient. Vasectomy reversal may be performed using micro- or macrosurgical techniques, each with its own advantages and disadvantages.

Belker et al. (20) and Fox (88) found that the fertility rate after vasectomy reversal decreased as the time between the reversal and the original vasectomy increased. The fertility rate can also be affected by postoperative scarring of the lumen, a lack of sperm in the ejaculate, and possibly the presence of sperm antibodies (178, 183, 232).

Lactational Amenorrhea Method

The lactational amenorrhea method (LAM) is a family planning method based on the physiology of breast feeding. If a breastfeeding woman meets the three LAM criteria, her risk of pregnancy in the first 6 months after childbirth is about 2%, or 1 in 50.

The three LAM criteria are:

1. Amenorrhea, defined as the absence of the menses. Menses return is defined as the first two sequential days of bleeding or spotting which may occur after 2 months postpartum.

2. Fully or nearly fully breastfeeding, includes exclusive breastfeeding, almost exclusive breastfeeding, and nearly fully breastfeeding, day and night, on demand by the infant. Efficacy and duration of LAM are enhanced with more intense breastfeeding patterns, especially during the earlier weeks and months.

3. Less than 6 months postpartum.

Q.1. When should LAM users begin another method?

Recommendation: Back-up methods are not necessary while the LAM criteria are met. However, another method can be used during the period of LAM protection if the woman so wishes. Back-up methods should be limited to methods that are appropriate for breastfeeding women.

According to WHO, progestin-only methods (e.g., POPs, Depo-Provera, Norplant implants) should not be initiated before 6 weeks postpartum, and estrogen-containing methods (e.g., COCs, CICs) should not be started by breastfeeding women before 6 months postpartum.

Rationale: While the LAM criteria are met, LAM is a very effective contraceptive method (214).

Nonhormonal methods have no effect on lactation or the infant. Progestin-only methods have no known effect but are WHO Category 3 (risks usually outweigh advantages) in the first 6 weeks postpartum due to theoretical concerns about steroid transmission in breast milk. Estrogenic methods generally should not be used by breastfeeding women prior to 6 months postpartum due to their effects on lactation (WHO Category 3) (302).

Recommendation: It is appropriate for a LAM user to have a contraceptive method on hand that she can initiate herself. A woman should have the opportunity to make an informed choice to begin any other method that is appropriate for her while she is still protected by LAM. She can then initiate that method when the LAM criteria no longer hold or she chooses to end reliance on LAM.

Rationale: The method a LAM user has on hand (for use after she is no longer relying on LAM) may be a woman’s chosen follow-up method, or it may be for use as a temporary complementary method until she has a chance to visit her family planning provider to procure the method she desires. A service provider can be reasonably sure that a LAM user is not pregnant if the LAM criteria are met. The provider can then provide the chosen method (as per the protocol for that method) before the end of LAM (214).

Having a contraceptive method on hand that the user can initiate herself when LAM expires (or when the woman no longer wishes to rely on LAM) is thought to have the potential of reducing the chance of a gap in protection.

Recommendation: Women using LAM are still at risk of STDs, including HIV/AIDS, and may need to use condoms or other barrier methods for STD protection.

Rationale: LAM does not offer protection from STDs or HIV. Clients at risk for these diseases should be encouraged to use barrier methods and counseled about behaviors that can decrease risk.

Q.2. Can LAM use be extended beyond 6 months?

Recommendation: The duration of LAM protection may be extended for a few months in amenorrheic women through support for optimal breastfeeding practices.

Rationale: Prenatal breastfeeding education and information on LAM can increase the duration of breastfeeding, lactational amenorrhea, and LAM protection (45, 223).

Recommendation: The extended versions of LAM (e.g., LAM-9, MAMA-9, LAM-12) are based on amenorrhea and maintenance of a high-frequency pattern of breastfeeding, with full or nearly full breastfeeding, and with breastfeeding before each supplemental feed.

Lactational amenorrhea beyond 6 months postpartum conveys a good deal of protection from pregnancy, although it provides less protection than in the first 6 months.

As with standard LAM, use of another method should be encouraged when menses return. If she is amenorrheic, before the woman ceases to fully or nearly fully breastfeed, she should return for counseling (either to continue relying on extended LAM, or for another contraceptive method if she wishes). (See Question 1.)

Rationale: The probability of becoming pregnant during lactational amenorrhea is low during the first 6 months postpartum. While the risk of pregnancy during lactational amenorrhea is higher after 6 months postpartum, among women with intensive breastfeeding practices the failure rate for lactational amenorrhea up to 1 year postpartum is comparable to the perfect-use failure rates for other reversible methods. However, more research is needed on the efficacy of the extended Lactational Amenorrhea Method (45, 138, 147, 225).

Natural Family Planning

Q.1. How effective are Natural Family Planning (NFP) methods?

Estimates of NFP effectiveness vary widely. NFP effectiveness depends upon several factors, including:

* The fertility indicator(s) used,

* The validity of the rules used,

* The type and quality of teaching,

* The ability of the woman to observe and interpret her fertility signs,

* The ability of the couple to abstain from vaginal intercourse when indicated by the rules, and

* Individual characteristics of the couple, such as the age of the woman and her history of pelvic infection or other determinants of lowered fertility.

Calendar-based methods

Estimate: Estimates from clearly reported trials that state the rule used range from 5% to 14% in the first year of use. A recent reanalysis of calendar method clinical studies found a typical failure rate estimate of about 20%.

Rationale: It is difficult to estimate the effectiveness of the calendar method because very few well-designed studies have been conducted. Many of the estimates are based upon surveys and do not report the requisite information required to calculate effectiveness rates. It is difficult to compare studies on the calendar method because many reports do not state what rule was used to identify the fertile time or if I couples understood the basis for the method (65, 165).

Single-indicator methods

(basal body temperature (BBT),

cervical mucus or ovulation methods)

Estimate: Estimates range from 3% with perfect use to about 20% with typical use.

Rationale: The probability of accidental pregnancy when using single indicator methods is highest when couples do not abstain during the fertile period. For users of the cervical mucus or ovulation methods, having intercourse during periods of stress on the woman also increases the risk of pregnancy by affecting the quality of mucus. For users of the BBT method, stress, illness, travel, or interrupted sleep can disrupt a woman’s typical biphasic pattern, thereby making it difficult to identify the fertile period for that cycle using the body temperature (114, 275, 356).

Two or more indicator methods

(symptothermal methods)

Estimate: Estimates range from about 2% with perfect use to about 15% to 20% with typical use.

Rationale: The use of two or more indicators can be somewhat more effective than the use of a single indicator (90, 114).

Q.2. Who can use NFP?

Recommendation: Women in different stages of their reproductive lives can use NFP. However, certain NFP methods, e.g., the calendar method, are inappropriate during long periods of anovulation, amenorrhea, or irregular cycles.

Rationale: Most women who are regularly cycling can use NFP. Women who are postmenarche, postpartum, breastfeeding, postabortion, or perimenopausal can also use NFP. However, since the hormonal patterns are altered, a woman may find it more difficult to interpret her fertility signs and must follow special rules to track her fertility. The specific rules used will depend upon the circumstances and the NFP method chosen. Calendar-based methods are not recommended for women in the situations mentioned above because many of these cycles are not ovulatory and are often very irregular, requiring prolonged required abstinence intervals, which may be difficult for many couples (307).

Recommendation: Because of the large range of failure rates of NFP methods, women with conditions that may be seriously affected by pregnancy must be counseled on the degree of risk of an unintended pregnancy.

Rationale: The higher range of failure rates of these methods may expose the user to an unacceptable risk of unintended pregnancy (302). (See Question 1.)

Q.3. Can women with vaginal infections use NFP?

Recommendation: Calendar-based or basal body temperature methods do not depend upon interpretation of cervical secretions and may be used if a woman is unable to interpret cervical mucus patterns.

It is not recommended that women rely on the cervical mucus method if they have an abnormal vaginal discharge.

Rationale: Abnormal pathologic discharge interferes with a woman’s ability to observe changes in cervical mucus patterns. If a woman has an abnormal discharge, she should be referred to a health care provider for appropriate diagnosis and treatment. If possible, couples should abstain until treatment is complete or be advised to use condoms to prevent re-infection. The male partner should also be treated at the same time, if required. Once the discharge has returned to normal, women can begin using the cervical mucus method.

Q.4. What client counseling is required?

Recommendation: Commitment by both the man and the woman is required for the effective use of NFP.

Rationale: NFP is a “couple method” and requires good communication and cooperation between partners. NFP is not only a method of family planning, but it is also a method of self-knowledge and self-control and mutual respect.

Recommendation: NFP requires the ability to observe and interpret fertility indicators accurately.

Rationale: Couples must be willing to monitor the changes in the woman’s fertility signs consistently so that the fertile time can be identified accurately.

Recommendation: NFP requires abstinence from vaginal intercourse for up to half the days of the menstrual cycle.

Rationale: On average, most NFP methods require 10 to 12 days of abstinence per cycle. The length of abstinence depends upon the NFP method chosen and individual characteristics of the woman’s cycle.

Recommendation: If the man or the woman abuses drugs or alcohol, offer another family planning method.

Rationale: If either the man or the woman abuses alcohol or drugs, it will be difficult for the couple to follow the rules of abstinence.

Recommendation: If the male partner is not interested in NFP, then the woman or couple should be informed of alternative methods.

Rationale: NFP will not be effective in preventing unplanned pregnancy if the male partner is unwilling to accept abstinence during the fertile period. Such couples should be informed of other family planning options.

Recommendation: If the man or the woman is at risk for acquiring or transmitting a STD, the couple should be counseled about risk factors for STD transmission.

Rationale: NFP is not protective against STDs, and couples at risk should be informed that to reduce their risk, they should abstain or use condoms.

Q.5. Can a woman with irregular cycles use NFP?

Using fertility indicators

Recommendation: Yes. If the couple uses fertility indicators (such as cervical mucus and basal body temperature) to identify the fertile time, then ovulation can be predicted and detected despite irregular menstrual cycles. Past cycle lengths do not influence the length of abstinence in the current cycle.

Rationale: Women with irregular menstrual cycles can still ovulate and be fertile. The fertile period in such women can only be identified by prospective NFP methods such as cervical mucus and BBT. In the presence of irregular cycles, the period of abstinence may be excessively long and unacceptable to some couples.

Using a calendar method based on a formula

Recommendation: For a woman with very irregular cycles, a calendar method based on a formula to predict the fertile time may be unacceptable due to the prolonged abstinence required.

Rationale: In the absence of relatively regular cycles, it is impossible for a woman to predict the fertile days in her current cycle using the calendar method. As cycle length variation increases, the number of days of abstinence increases. The most common “rule” used to predict the fertile time using a formula is subtracting a certain number of days from the length of the shortest (usually 18 to 20) and longest cycles (usually 8 to 10) in the past 6 to 12 months. If, for example, the longest cycle is 45 days and the shortest cycle is 20 days, a couple would have to abstain for more than 30 days in the woman’s current cycle.

Cycle length is determined by starting to count on Day 1 of menses and counting forward until the day before the next menses begins.

Prolonged abstinence may lead to increased risk taking and greater risk of pregnancy if intercourse occurs during the fertile time (166).

Using a calendar method based on a “blanket” rule

Recommendation: Couples using a “blanket” (calendar) rule may be at increased risk for pregnancy if the woman has a very short or very long cycle.

Rationale: When the fertile time is predicted using a “blanket” rule–in which a set number of days each cycle is identified as the fertile time–the length of abstinence is not increased if the woman has irregular cycles. An example of a “blanket” rule is if all couples abstain starting on Day 8 of the woman’s cycle and resume vaginal intercourse on Day 21. Couples using this rule would abstain for 13 days each cycle, regardless of whether the woman has irregular cycles. However, in the presence of long and irregular cycles, it is very likely that the couple will have intercourse on a fertile day since ovulation usually occurs around 2 weeks before the next menstruation. Thus a woman with a 39-day cycle would resume intercourse on day 21 and probably ovulate around day 25 (166).

Q.6. Are there any risks or harmful effects of using NFP?

Recommendation: No medical side effects are associated with the use of NFP.

Rationale: No drugs or devices are used with NFP. Fertility-awareness-based methods produce no medical side effects. However, periodic abstinence and fear of unplanned pregnancy may create tension and psychological stress in some couples (114).

Recommendation: The best evidence indicates that there is no increased risk to the fetus associated with the use of NFP.

Rationale: Recent studies show that there is no increased risk of spontaneous abortion, small birth size, low birth weight, or malformation to fetuses among users of NFP (31, 103).

Q.7. Can NFP be combined with other methods?

Recommendation: Yes. By definition, NFP requires that only abstinence during the fertile time be used to avoid pregnancy. However, couples who know how to identify the fertile time may choose to use a barrier method or withdrawal during the fertile time. These alternative approaches are not NFP but are referred to by different names, such as “fertility-awareness methods” or “mixed methods.”

For example, women who wish to breastfeed can use the lactational amenorrhea method (LAM) in lieu of, or before, using NFP. When the criteria for LAM use are no longer met (fully or nearly fully breastfeeding, infant less than 6 months old, no menses return), the woman can use NFP to identify her potentially fertile days.

Rationale: For couples who are not at risk for STDs, an approach that combines the use of fertility awareness and barrier methods or withdrawal may increase the acceptability and effectiveness of these methods, since the use of other contraceptive methods is needed only when the woman is fertile. Further research is necessary to establish guidelines for combining fertility awareness and barrier method use (74, 144, 228).

Barrier Methods

Spermicides (Gels, Foam, Tablets, and Film)

Q.1. Are there any risks to a fetus conceived while using spermicides or due to spermicide use during pregnancy for STD prevention?

Recommendation: The weight of the evidence is that there is no risk to the fetus from spermicide exposure.

Rationale: The active ingredient in most spermicide products, nonoxynol-9 (N-9), is absorbed in small quantities from the vagina during use. No adverse systemic effects from N-9 have ever been shown in women. One study found that users of spermicide products containing nonoxynol-9 or octoxynol had a higher risk of congenital malformations in pregnancies conceived during use than did nonusers. But several subsequent studies on spermicide use and birth defects have not shown any association, and researchers do not believe that spermicide use has any adverse effects on the fetus (70, 133, 251).

Q.2. How often can spermicide be used in a given time period?

Recommendation: Spermicide use every other day does not cause significant irritation, whereas continued use as frequently as once or twice a day may cause some tiny breaks in the vaginal lining. If irritation is detected upon examination and if a reasonable alternative is available, then the client should be advised to discontinue the spermicidal product until healing is complete.

Rationale: The active ingredients of most spermicide products are surfactants that disrupt cell membranes of spermatozoa, pathogens, and genital epithelium. In one study of frequent N-9 insertion, erythema and microscopic epithelial lesions were equally frequent among women inserting N-9 every other day as among placebo users. The rate of irritation was twice as high among women inserting N-9 once or twice daily, and 5 times higher among women inserting four N-9 suppositories daily than among placebo users. Similar findings have been reported in a WHO-sponsored study of the spermicide menfegol (100, 227).

Experts fear that the epithelial lesions of spermicide-associated irritation may increase the risk of contracting HIV infection if exposure to HIV occurs. This has not been demonstrated in a human study, but it is plausible, and local irritation should be avoided.

Recommendation: Discomfort with spermicide use is uncommon when used at typical family planning frequencies of once per day or less. If discomfort is reported, a different spermicide product with different ingredients may solve the problem. If discomfort persists, a different contraceptive method is indicated.

Rationale: In studies of spermicide use (approximately one to two times per day) for family planning purposes, roughly 5% to 10% of women have symptoms of discomfort after use. The clinical significance of discomfort is unclear because discomfort is a self-perceived problem, and it may not be correlated with signs of vaginal or cervical irritation detected during examination (80, 227).

Recommendation: A woman should insert a new dose of her spermicide product before each act of intercourse. Furthermore, a woman should insert a new dose of spermicide if intercourse takes place an hour or more after initial insertion.

Rationale: In order to be effective, the spermicide must be high in the vagina near the cervix, with a sufficient concentration of the active ingredient. Due to different delivery formulations, some products leak down toward the vulva more quickly than others; some spread better than others. Manufacturers of suppositories, gels, and film generally claim that their product is effective for up to 1 hour after insertion, but the period of effectiveness might be longer. Since spermicides are typically less effective in preventing pregnancy than other methods, it is prudent to insert a new dose for each intercourse (114).

Q.3. Do spermicides protect one against pregnancy? HIV/AIDS? Other STDs?

Against pregnancy?

Recommendation: Yes. Spermicides will provide a fairly high degree of pregnancy prevention as long as they are used correctly and consistently. However, with typical use, spermicides provide much less protection against pregnancy than with perfect use.

Rationale: The failure rates of spermicides in the first year of use range from 6% with perfect use to 21% with typical use. These rates are similar to those for the diaphragm and female condom (276).

Against HIV/AIDS?

Recommendation: Possibly. Spermicides are not generally recommended for HIV prevention.

However, for sexually active women who cannot use male or female condoms, a spermicide product may be preferable to unprotected intercourse, unless there are multiple acts of intercourse per day.

Rationale: Little research has been done on spermicide use and HIV risk, and the findings of the only two published studies conflict. In one study, nonoxynol-9 contraceptive sponge users had a higher incidence of HIV infection. In the second study, N-9 suppository users had a lower incidence of HIV. Until large randomized studies currently under way can resolve the controversy, spermicide alone cannot currently be recommended for HIV prevention.

Theoretically, spermicides may reduce the incidence of HIV indirectly by preventing bacterial STD cofactors. Spermicides have also been shown to have direct effects on HIV in vitro (80, 81, 132, 155, 220, 281).

The highest risk of sexually acquired HIV infection is associated with unprotected intercourse. Women need methods to protect themselves against HIV and other STDs, even if protection is only partial (71, 230).

Against other STDs?

Recommendation: Yes, spermicides are modestly protective against cervical gonorrhea and chlamydia, compared with no method.

The effectiveness of any coital-dependent method (i.e., one that must be applied at or around the time of intercourse) depends on the consistency and correctness of use. For these methods, acceptability and compliance are as important, if not more so, as their effectiveness during perfect use. Even if a female method is less efficacious than the male condom during perfect use, it may have a greater impact on disease rates if it is used more consistently. Consistent use of condom with spermicide may be more effective.

Rationale: Spermicides have been shown to provide protection against some bacterial STDs. Studies with different kinds of participants and different study designs have consistently demonstrated that spermicide use reduces the number of new gonorrhea! and chlamydial infections. One study found an overall reduction in gonorrhea of about 50% in nonoxynol-9 users, but that figure includes both consistent and correct users as well as inconsistent users. A greater reduction was found among the most consistent users of the spermicide. Another study found a 25% reduction overall in nonoxynol-9 users. In studies that have compared bacterial STD risk among women relying on male condoms with those using a spermicidal method, the risks for infections were about the same. Most likely, the spermicides were used more consistently than were male condoms (180, 200, 229, 293).

Q.4. How soon postpartum or postabortion can spermicides be used?

Recommendation: According to the WHO Eligibility Criteria, spermicides can be used anytime postpartum or post-abortion.

Although some providers recommend that spermicide should not be used until 6 weeks after delivery or abortion and healing and uterine involution are complete, there is no evidence to support this practice.

Rationale: Use of a spermicide by breastfeeding women both prior to and after 6 weeks postpartum and use after a first- or second-trimester abortion or postseptic abortion are WHO Category 1 (no restrictions). Thus, the WHO recommends the use of spermicides in any of these circumstances. By extrapolation, nonbreastfeeding women can use spermicides any time postpartum as well (302).

Condoms (Male and Female)

Q.1. Do condoms protect one from STDs/HIV/AIDS?

Male condoms

Recommendation: Yes, couples who use the male latex condom correctly and consistently have a lower risk of acquiring all STDs, including HIV, compared with nonusers. The average reduction is about 50%, although recent studies of HIV show that protection with consistent condom use can be close to 100%.

Rationale: All studies have found that male latex condom users have a lower risk of STDs than nonusers (33,57,80,110, 237). The overall risk reduction appears to be about 50%, but that figure is a gross estimate that includes consistent and correct users as well as inconsistent users. In Thailand, a condom-only campaign in brothels is associated with population-based reductions in gonorrhea and HIV rates (110).

Full-time latex condom users may reduce their risk to near-zero. A multicenter Italian study followed seronegative female sex partners of HIV-infected men for a median of 24 months. The HIV incidence rate was reduced by 90% in women whose partners always used condoms compared with women whose partners used them inconsistently or never; women whose partners were inconsistent condom users did not benefit (57).

In a multicountry European collaborative study, about half of 343 couples used condoms at every coital act, and no new HIV infections occurred among the consistent users. For the couples who used condoms inconsistently, new HIV infections occurred at the rate of 4.8 per 100 per year, even though 50% of the inconsistent users reported using condoms at least half the time (237). These two studies show that consistent condom use is highly effective protection against HIV transmission but that inconsistent use carries considerable risks of HIV infection (57, 237).

Female condoms

Recommendation: If used correctly and consistently, the female condom should be very effective in preventing STDs (including HIV), but this has not been confirmed in human use studies.

Rationale: Only one cross-sectional study of the female condom and STD re-occurence has been done. Women with trichomoniasis were treated, enrolled, and followed for 45 days. Consistent users had no re-infections, while 14% of inconsistent users and nonusers were re-infected. The plastic membrane of the female condom is impermeable to HIV and other STD organisms, so the device may reduce the risk of HIV and other STDs in consistent users (67, 259).

Q.2. Can condoms (male and female) be reused?

Recommendation: Male condoms should not be reused.

Rationale: The reuse of male condoms cannot be recommended until further research is completed. Anecdotal reports suggest that reuse of male condoms is associated with higher breakage rates. The latex membranes are generally not strong enough to withstand repeated stretching, friction, and cleaning. In one large study, unrolling condoms before use increased the breakage and slippage rate (265).

Recommendation: Female condoms should not be reused.

Rationale: The reuse of female condoms is not currently recommended, pending further research. However, anecdotal reports from acceptability studies show that a minority of women use a female condom more than once. Reuse has not been associated with higher breakage rates; female condom breakage is rare in general. Research is currently underway to determine whether reuse reduces the structural strength of the device (increases breakage) and/or increases the risk of communicating STDs.

Q.3. When should the condom be put on?

Recommendation: Male condoms should be put on after erection and before genital and/or anal contact.

The female condom should be put into place any time before the penis touches the vagina in order to prevent exposure to pre-ejaculate and semen.

Rationale: Although viable sperm are generally absent from pre-ejaculatory fluid, HIV is present in the pre-ejaculate of HIV-positive men. Thus the pre-ejaculate may transmit disease, and the condom should be in place before genital contact occurs (125, 222).

Q.4. Does providing condoms in more than one size reduce slippage and breakage?

Recommendation: There is no evidence that different sizes will reduce breakage and slippage.

There is no need to provide more than one size latex condoms.

Rationale: Some condom users complain of condoms being too small or too large, and some researchers have presumed that breakage could be minimized if condoms were made in different sizes. One study evaluated breakage rates and acceptability of larger (55 mm flat diameter) and smaller (49 mm) condoms against the industry standard condom (52 mm). In three countries, breakage rates were 5.5% and 7.4% for the standard and larger devices, respectively. In three other countries, breakage rates were under 5% and similar for the standard and smaller condoms; slippage rates were also similar. Further, condom size had a minimal impact on device acceptability. Certain individuals might benefit from different condom sizes, but the impact has not been demonstrated, and it is not justified for a program to invest in multiple condom sizes (79).

Q.5. Should latex condoms be used with oil-based lubricants?

Recommendation: No. Latex condoms should not be used with oil-based lubricants or products that have an oil as a major ingredient. Oils weaken condoms and can increase the risk of breakage.

Clients who use condoms should be counseled on what locally available non-oil-based lubricants are appropriate with condom use.

Some substances that cause deterioration of latex condoms within an hour of exposure are mineral oil, baby oil, petroleum jelly, suntan oil, olive oil, peanut oil, corn oil, sunflower oil, palm oil, margarine, coconut oil, dairy butter, insect repellents, burn and hemorrhoidal ointments, rubbing alcohol, cod oil, and shark oil. Lubricants that contain these products should not be recommended for use with latex condoms.

Other products that weaken latex condoms are specific vaginal creams, vaginal spermicides, and sexual lubricants. Some of the brands that were identified as harmful to condoms are:

* Vaginal creams (Monistat, Estrace, Femstat, Vagisil, and Premarin),

* Vaginal spermicides (Rendell’s Cone and Pharmatex Ovule), and

* Sexual lubricants (Elbow Grease, Hot Elbow Grease, and Shaft).

Rationale: Mineral oil has been shown to weaken latex condoms significantly with an exposure time of 60 seconds.

Studies have found that some condom users think products that wash off easily with wafer are water-based and therefore acceptable to use with condoms. However, several of the lotions that clients labeled as water-based contained mineral oil as a main ingredient (10, 114, 286).

Recommendation: Products that are considered water-based have not been shown to be harmful to condoms. Water-based lubricants may reduce the risk of condom failure.

Rationale: One study found lower condom failure rates when condoms were used with water-based lubricants. However, more research is needed (92).

Diaphragms/Cervical Caps

Q.1. Does one size diaphragm or cervical cap fit all?

Diaphragms

Recommendation: No, diaphragms have to be fitted, and a variety of sizes needs to be available where this method is offered.

Rationale: Two studies of a Nonspermicidal Fit-Free Diaphragm (60 mm) have been done. The first report, an analysis of past diaphragm use, found the Pearl pregnancy rate to be 1 per 100 woman-years. In the second, a prospective nonrandomized trial, the 12-month life-table pregnancy rate was 24.1 per 100 women, and the high failure rate led to early termination of the study. The effectiveness of this modified approach to diaphragm use has not been confirmed (256, 266).

Cervical caps

Recommendation: No, currently available cervical caps must be fitted, and a variety of sizes needs to be available where this method is offered.

Rationale: Until one-size-fits-all caps are available, fitting caps to each client is recommended. New cervical barrier devices have been devised, at least one of which is one-size-fits-all, and human use studies are under way (124,186).

Q.2. Are there any restrictions to use of a diaphragm or cervical cap based on the number of births a woman has had?

Diaphragms

Recommendation: No. Women with any number of births can use the diaphragm. The fit of the device should be checked after delivery or second-trimester abortion, however.

Rationale: Since the diaphragm comes in sizes from 50 mm to 105 mm in different models, almost all vaginas can be accommodated. The size and muscle tone of the upper vagina can change after pregnancy, however, so a new device may be needed.

It is unclear whether the effectiveness of the diaphragm varies according to parity. In one large study, parous women had a lower pregnancy rate than nulliparous women; in another, the rate among parous women was higher than that in nulliparous women. Parous women do not need to be advised that they are at higher risk of pregnancy (114,278).

Cervical caps

Recommendation: No. Women of any parity can use the cervical cap, but the fit of the device should be checked after delivery or second-trimester abortion. Parous women tend to have a much higher pregnancy rate than nulliparous women.

Rationale: The cervical cap comes in four sizes: 22, 25, 28, and 31 mm. Most women can be fined properly, but perhaps 10% of prospective users cannot be fit and must use a different method.

In a large clinical trial, the pregnancy rate was substantially higher among parous women than nulliparous women for both typical and perfect use (114, 240, 278).

Q.3. How soon postpartum or postabortion can a diaphragm or cervical cap be used?

Recommendation: The diaphragm and the cervical cap should not be used until 6 weeks after delivery (vaginal or cesarean) or second-trimester abortion and healing is complete. Refitting may be necessary at that time (refining is not necessary after a first-trimester abortion).

If intercourse occurs prior to 6 weeks, the use of another appropriate method (i.e., condom) should be recommended.

Rationale: The shape of the cervix, the size of the vaginal vault, and/or vaginal muscle tone may change after pregnancy and delivery or after second-trimester abortion. It takes 4 to 6 weeks for the uterine involution to be complete, and bleeding/spotting can continue for up to 8 weeks as well (cap use is contraindicated during bleeding).

Additionally, there is marked weight loss after delivery, and many providers recommend refitting after a weight loss of more than 7 kg (114, 240, 296, 302).

Q.4. Is pregnancy prevented if the diaphragm is used without spermicide?

Recommendation: Yes, but not as effectively as with spermicide.

Until better data on contraceptive effectiveness refute the conventional recommendations, users should be advised to add spermicide to fined diaphragms.

Rationale: Two studies of nonfitted diaphragms without spermicide had conflicting results. Research on fitted diaphragm use without spermicide are also conflicting. In a retrospective review of patient records, women using fitted diaphragms continuously (removing them only to wash) without spermicide had a lower pregnancy rate than did women following the conventional instructions. In a randomized trial comparing fitted diaphragm use with versus without spermicide, the typical use and perfect use pregnancy rates were lower in the diaphragm with spermicide group, but the study was small, and the differences were not statistically significant.

Some providers believe that spermicide cost, messiness, and potential for irritation have resulted in poor compliance, and they recommend diaphragm use without spermicide in an effort to enhance acceptability. But another important attribute of the diaphragm is that diaphragms used with spermicide protect against cervical infections and that spermicide use may reduce the risk of HIV infection. If spermicide use is partly responsible for reducing the risk of STD infection in women using diaphragms, it would bee disservice to instruct women to omit spermicide (27, 33, 82, 227, 256, 266).

Q.5. How long must a woman wait after the last act of intercourse to remove the diaphragm or cervical cap?

Recommendation: Diaphragm and cervical cap users should wait at least 6 hours after intercourse before removing the device or douching.

Upon removal, diaphragms should be washed (and dried prior to storing).

Rationale: Spermatozoa remain viable in the vagina for several hours, but the great majority of sperm cells that are capable of entering the cervix do so within 2 hours post-ejaculation. N-9 spermicide can retain its contraceptive effect for a longer time: more than a day inside a cervical cap and 12 hours inside a diaphragm. The optimum time that diaphragms and caps should remain in place has not been tested, and, in the absence of evidence to the contrary, the conventional 6-hour recommendation is a sensible compromise (114, 174, 175, 207).

Q.6. Should a diaphragm user insert extra spermicide before having a second intercourse?

Recommendation: Yes, a diaphragm user should insert a new dose of spermicide before each episode of intercourse. A woman should insert a new dose of spermicide if intercourse takes place 6 hours or more after diaphragm insertion.

Rationale: No research has been done to compare diaphragm users who insert more spermicide before a second episode of intercourse and those who do not. As noted. N-9 spermicide may retain its contraceptive effect for more than a day inside a cervical cap and for 12 hours inside a diaphragm, but the impact of multiple ejaculations on N-9 potency is not known. In the absence of concrete data, it is prudent to insert a new dose of spermicide for each intercourse (114, 174, 175).

Q.7. Does use of a diaphragm or cervical cap increase the risk of urinary tract infections?

Recommendation: Yes, diaphragm use increases the risk of urinary tract infection (UTI).

Rationale: Most studies have found that diaphragm users develop UTI at a rate two to three times higher than nondiaphragm users. However, it is not understood why this is the case. Foreplay and intercourse seem to introduce E. cold bacteria into the vagina. The spermicide and probably the diaphragm itself encourage vaginal and urethral colonization of the E. coli.

Several approaches may solve the UTI problem. Urination just before and just after intercourse may offer some protection. Wearing the diaphragm for less time may help. A smaller device or a different rim style may relieve pressure on the urethra. Switching to a cervical cap may be an option that retains many of the same advantages as the diaphragm (89, 114, 118).

Recommendation: There is no evidence that the cervical cap increases the risk of UTI, although it may do so.

Rationale: Since there are relatively few cervical cap users, it is difficult to study side effects of cap use. Since the cervical cap shares with the diaphragm the feature of extended spermicide exposure, it is possible that cap use will increase the risk of UTI to a similar extent (118).

Q.8. Does a diaphragm or cervical cap protect against: HIV/AIDS: Other STDs?

Against HIV/AIDS?

Recommendation: Possibly. Diaphragms and caps, even with spermicides, cannot currently be recommended for HIV prevention. Diaphragm use may indirectly reduce the incidence of HIV, however, by preventing bacterial STD cofactors that increase the risk of HIV transmission.

For sexually active women who cannot use male or female condoms, a diaphragm, cap with spermicide, or spermicide alone is unlikely to be riskier than completely unprotected intercourse and may help prevent upper reproductive tract infections.

Rationale: The effectiveness of the diaphragm and cap against HIV is not known. Much depends on the site of infection; if the portal of virus entry is the cervix, the diaphragm and cap should confer good protection. Until the effectiveness of N-9 spermicide is established, diaphragm or cap use with N-9 spermicide cannot be recommended for HIV prevention (264, 281).

The highest risk of sexually acquired HIV infection is associated with unprotected intercourse. Women need methods to protect themselves against HIV and other STDs, even if protection is only partial (71, 81, 230).

Against other STDs?

Recommendation: Probably. Users of diaphragms (and probably cervical caps) with spermicides probably have a modestly lower risk of gonorrhea and chlamydia than nonusers.

Rationale: Diaphragm use has been found to reduce the risk of bacterial STD and pelvic inflammatory disease (PID). One study found a 60% reduction in the risk of PID in diaphragm users compared with women using no contraceptive method. The overall reduction of bacterial cervical infections from spermicide use alone is about 25% to 50%, but that figure is a gross estimate that includes consistent and correct users as well as inconsistent users. Thus, use of spermicides with diaphragm or cap may reduce the risk of cervical infections. In studies of bacterial STDs among diaphragm users and women whose partners used male condoms, diaphragm users had lower STD risk than women depending on their partners’ use of a male condom. The effectiveness of any coital-dependent method (i.e., one that must be applied at or around the time of intercourse) depends on the consistency and correctness of use. For these methods, acceptability and compliance are as important, if not more so, as their efficacy in preventing disease. Even if a female method is less efficacious than the male condom, it may have a greater impact on disease rates if it is used more consistently. Since the diaphragm is a method that combines a physical barrier (the latex or silicon device) and a chemical barrier (the spermicide), it may be more effective than spermicide alone, although there are no data to confirm this (12, 33, 80, 140).

General

Q.1. What should be the role of barrier methods in family planning/reproductive health programs?

Recommendation: Barrier methods should be part of the method mix in all family planning/reproductive health clinics. The advantages of barrier methods, such as STD protection, should be emphasized to providers and clients, as should be the importance of correct and consistent use to achieve pregnancy protection. Barrier methods provide less protection against pregnancy and STDs with typical use.

Barrier methods should be presented to clients equally with other methods, allowing the client to choose the method most suitable for him or her.

Rationale: Many users of family planning are at risk of contracting sexually transmitted diseases (STDs) including HIV, and yet they are unable to avoid their risky sexual encounters. Therefore they need preventive methods. Barrier methods are the only class of family planning methods that protects users against STDs. A second reason that barrier methods are important is that some people in need of family planning are not medically eligible to use, or are unwilling to use, hormonal methods, IUDs, NFP, or surgical contraception.

Yet anecdotal evidence points to provider bias against barrier methods. Providers may perceive barriers to be ineffective; they may also worry about the time required for client education, motivation, and fitting (in the case of the diaphragm and cervical cap).

While the typical effectiveness of barrier methods is indeed less than that of hormonals and IUDs, for consistent and correct users, barrier method effectiveness is quite high. Although some barrier methods do require more time with new acceptors, the potential benefits of STD prevention and communication with sexual partners are considerable (8, 79, 202, 279).

(*) In breastfeeding women, bleeding in the first 56 days (8 weeks) postpartum is NOT considered “menstrual” bleeding because it is not preceded by ovulation.

(*) Nonsteroidal anti-inflammatory drugs (e.g., ibuprofen) should be used instead of aspirin because of aspirin’s stronger and longer-lasting inhibitory effects on platelet aggregation (aspirin promotes bleeding) (5, 83).

(*) Norplant is the registered trademark of The Population Council for levonorgestrel subdermal implants.

(*) Not all clinically apparent vaginal infections are due to STDs.

RELATED ARTICLE: How to Be Reasonably Sure the Woman Is Not Pregnant

You can be reasonably sure the woman is not pregnant if she has no symptoms (see “History,” below) or signs (see “Physical Exam,” below) of pregnancy and she:

* Has not had intercourse since last normal menses, or

* Has been correctly and consistently using another reliable method, or

* Is within the first 7 days after normal menses, or

* Is within 4 weeks postpartum (for nonlactating women), or

* Is within the first 7 days postabortion, or

* Is fully breastfeeding, amenorrheic, and less than 6 months postpartum (see “Relying on Lactational Amenorrhea,” below).

History or symptoms of pregnancy:

* Absent (or altered) menses,

* Nausea (with or without vomiting),

* Fatigue (persistent),

* Breast tenderness (and breast enlargement),

* Increased frequency of urination,

* Maternal perception of fetal movements (late symptom: at 16 to 20 weeks gestation).

Physical exam. Physical exam is seldom necessary except to rule out pregnancy of greater than 6 weeks, when uterine enlargement begins to be noticeable. Later (around 18 weeks), the fetal heartbeat can be heard with a stethoscope, and fetal movements can be perceived by the examiner.

Laboratory tests. In certain settings, pregnancy tests are not very helpful or practical because highly sensitive tests (positive about 10 days after conception) are not usually affordable. However, in cases where the possibility of pregnancy is difficult to rule out, a highly sensitive pregnancy test may be helpful, if it is readily available and not too expensive and if it is part of rot/tine clinic practice.

Relying on lactational amenorrhea method. The lactational amenorrhea method (LAM) is a highly effective method of contraception (98% protection during the first 6 months postpartum in women who are fully or nearly fully breastfeeding(*) and amenorrheic) (156, 157, 189). The effectiveness of LAM in the second 6 months postpartum is under study (159). (See p. 26.)

A service provider can be reasonably sure that a woman is not pregnant if she is still amenorrheic, within the first 6 months postpartum, fully or nearly fully breastfeeding,(*) and has no clinical symptoms of pregnancy. When an accurate pregnancy test is not easily available or affordable, and a woman more than 6 months postpartum requests an IUD,(**) or Norplant implants, or injectables, you can still be reasonably sure she is not pregnant if the woman has kept her breastfeeding frequency high,(***) and she is still amenorrheic.

It should be noted that bleeding in the first 8 weeks (56 days) postpartum is not considered “menstrual” bleeding in breastfeeding women (22, 156, 157, 159).

(*) “Fully” breastfeeding includes exclusive or almost exclusive breastfeeding (only occasional tastes of foods or water) day and night. “Nearly fully” breastfeeding means that supplemental feedings are given but comprise a minimal Dart of the infant’s diet.

(**) It is more important to rule out pregnancy before inserting an IUD than before starting hormonal methods because of the risk of septic miscarriage with the IUD.

(***) A woman who breastfeeds 10 times per day or more or who gives more than 80% of her infant’s meals as breastfeeds is at less risk of being fertile. Breastfeeding before giving each supplement is optimal.

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