KEY CLINICAL UPDATES IN CONTRACEPTION & FAMILY PLANNING
A different on-demand vaginal contraceptive, a vaginal pH regulator gel containing lactic acid-citric acid-potassium bitartrate (Phexxi), was FDA approved for use in the United States in 2020.
In a clinical study of the efficacy of Phexxi, the 7-cycle cumulative pregnancy risk was 7% when used as directed and 14% with typical use.
Unintended pregnancies are a worldwide problem but disproportionately impact developing countries. From 2010 to 2014, it is estimated that 44% of pregnancies worldwide were unintended and 56% of them resulted in an abortion. In developed regions, the unintended pregnancy rate fell by 30% compared to 1990–1994, whereas it fell by only 16% in developing regions over this time frame. It is important for primary care providers to educate their patients about the benefits of contraception and to provide options that are appropriate and desirable for the patient.
A. Combined Oral Contraceptives
1. Efficacy and methods of use
Combined oral contraceptives have a perfect use failure rate of 0.3% and a typical use failure rate of 8%. Their primary mode of action is suppression of ovulation. The pills can be initially started on the first day of the menstrual cycle, the first Sunday after the onset of the cycle, or on any day of the cycle. If started more than 5 days after the first day of the cycle, a backup method should be used for the first 7 days. If an active pill is missed at any time, and no intercourse occurred in the past 5 days, two pills should be taken immediately, and a backup method should be used for 7 days. If intercourse occurred in the previous 5 days, emergency contraception should be offered. A backup method should be used for 7 days.
2. Benefits of oral contraceptives
Noncontraceptive benefits of oral contraceptives include lighter menses and improvement of dysmenorrhea, decreased risk of ovarian and endometrial cancer, and improvement in acne. Functional ovarian cysts are less likely with oral contraceptive use. There is also a beneficial effect on bone mass.
3. Selection of an oral contraceptive
Any of the combination oral contraceptives containing 35 mcg or less of ethinyl estradiol or 3 mg of estradiol valerate are suitable for most women. There is some variation in potency of the various progestins in the pills, but there are essentially no clinically significant differences for most women among the progestins in the low-dose pills. There is insufficient evidence that triphasic oral contraceptives provide any benefit compared to monophasic oral contraceptives in terms of effectiveness, bleeding patterns, or discontinuation rates. Therefore, monophasic pills are recommended as a first choice for women starting oral contraceptive use. Women who have acne or hirsutism may benefit from treatment with desogestrel, drospirenone, or norgestimate, since they are the least androgenic. Pills are typically packaged in 21- or 28-day cyclic regimens but may be taken continuously to allow the user to decide if and when she has a withdrawal bleed. Studies have not shown any significant risk from long-term amenorrhea in patients taking continuous oral contraceptives. The low-dose oral contraceptives commonly used in the United States are listed in Table 18–2.
Table 18–2.Commonly used low-dose oral contraceptives (listed within each group in order of increasing estrogen dose). ||Download (.pdf) Table 18–2. Commonly used low-dose oral contraceptives (listed within each group in order of increasing estrogen dose).
|Name ||Progestin ||Estrogen (Ethinyl Estradiol) ||Cost per Month1 |
|Alesse2,3 ||0.1 mg levonorgestrel ||20 mcg ||$35.20 |
|Loestrin 1/202 ||1 mg norethindrone acetate ||20 mcg ||$28.65 |
|Mircette2 ||0.15 mg desogestrel ||20 mcg ||$59.98 |
|Yaz2 ||3 mg drospirenone ||20 mcg ||$67.87 |
|Loestrin 21 1.5/302 ||1.5 mg norethindrone acetate ||30 mcg ||$26.67 |
|Low Ogestrel2 ||0.3 mg norgestrel ||30 mcg ||$30.52 |
|Levora2 ||0.15 mg levonorgestrel ||30 mcg ||$30.92 |
|Desogen2 ||0.15 mg desogestrel ||30 mcg ||$34.33 |
|Yasmin2 ||3 mg drospirenone ||30 mcg ||$76.72 |
|Brevicon2, Modicon2 ||0.5 mg norethindrone ||35 mcg ||$32.17 |
|Demulen 1/352 ||1 mg ethynodiol diacetate ||35 mcg ||$29.88 |
|Ortho-Novum 1/352 ||1 mg norethindrone ||35 mcg ||$29.47 |
|Ortho-Cyclen2 ||0.25 mg norgestimate ||35 mcg ||$32.23 |
|Gildagia2 ||0.4 mg norethindrone ||35 mcg ||$44.84 |
|Combination: Extended-Cycle |
|LoSeasonique (91-day cycle)2 ||0.10 mg levonorgestrel (days 1–84)/0 mg levonorgestrel (days 85–91) ||20 mcg (84 days)/10 mcg (7 days) ||$88.53 |
|Amethyst (28-day pack) ||90 mcg levonorgestrel ||20 mcg ||$59.40 |
|Seasonique (91-day cycle)2 ||0.15 mg levonorgestrel (days 1–84)/0 mg levonorgestrel (days 85–91) ||30 mcg (84 days)/10 mcg (7 days) ||$66.95 |
|Estrostep2 || |
1 mg norethindrone acetate (days 1–5)
1 mg norethindrone acetate (days 6–12)
1 mg norethindrone acetate (days 13–21)
|Cyclessa2 || |
0.1 mg desogestrel (days 1–7)
0.125 mg desogestrel (days 8–14)
0.15 mg desogestrel (days 15–21)
|25 mcg ||$33.64 |
|Tri-Lo-Estarylla || |
0.18 mg norgestimate (days 1–7)
0.215 mg norgestimate (days 8–14)
0.25 mg norgestimate (days 15–21)
|25 mcg ||$61.56 |
|Trivora2,3 || |
0.05 mg levonorgestrel (days 1–6)
0.075 mg levonorgestrel (days 7–11)
0.125 mg levonorgestrel (days 12–21)
|Ortho-Novum 7/7/72,3 || |
0.5 mg norethindrone (days 1–7)
0.75 mg norethindrone (days 8–14)
1 mg norethindrone (days 15–21)
|35 mcg ||$32.17 |
|Tri Estarylla2,3 || |
0.18 mg norgestimate (days 1–7)
0.215 mg norgestimate (days 8–14)
0.25 mg norgestimate (days 15–21)
|35 mcg ||$39.32 |
|Tri-Norinyl2,3 || |
0.5 mg norethindrone (days 1–7)
1 mg norethindrone (days 8–16)
0.5 mg norethindrone (days 17–21)
|35 mcg ||$39.35 |
|Progestin-Only Pill |
|Ortho Micronor2,3 ||0.35 mg norethindrone to be taken continuously ||None ||$39.54 |
|Slynd ||4 mg drospirenone (days 1–24) ||None ||$194.00 |
Several medications interact with oral contraceptives potentially decreasing their efficacy, typically by causing induction of microsomal enzymes in the liver. Some commonly prescribed medications in this category are phenytoin, phenobarbital (and other barbiturates), primidone, topiramate, carbamazepine, rifampin, and St. John’s wort. Women taking these medications should use another means of contraception for maximum safety.
Antiretroviral medications, specifically ritonavir-boosted protease inhibitors, may significantly decrease the efficacy of combined oral contraceptives. Other antiretrovirals, such as nonnucleoside reverse transcriptase inhibitors, have smaller effects on oral contraceptive efficacy, while nucleoside reverse transcriptase inhibitors do not appear to have an effect on contraceptive efficacy.
5. Contraindications and adverse effects
Oral contraceptives have been associated with many adverse effects; they are contraindicated with some conditions and should be used with caution in others (Table 18–3).
Table 18–3.Contraindications to use of combined hormonal contraceptives. ||Download (.pdf) Table 18–3. Contraindications to use of combined hormonal contraceptives.
Thrombophlebitis or thromboembolic disorders (past or present)
Stroke or coronary artery disease (past or present)
Cancer of the breast (known or suspected)
Undiagnosed abnormal vaginal bleeding
Estrogen-dependent cancer (known or suspected)
Hepatocellular adenoma (past or present)
Diabetes mellitus with vascular disease
Age ≥ 35 and smoking ≥ 15 cigarettes daily
Migraine with aura
Surgery or orthopedic injury requiring prolonged immobilization
Migraine without aura
Heart or kidney disease
Cholestasis during pregnancy
Sickle cell disease (S/S or S/C type)
The risk of heart attack is higher with use of oral contraceptives in certain populations, but the risk attributable to oral contraceptives is low in reproductive age women. Cigarette smoking, obesity, hypertension, diabetes mellitus, or hypercholesterolemia increases the risk. Smokers over age 35 and women with other cardiovascular risk factors should use other non-estrogen–containing methods of birth control.
B. THROMBOEMBOLIC DISEASE
A three- to five-fold increased rate of venous thromboembolism is found in oral contraceptive users, but the absolute risk is very low (5–6 per 100,000 woman-years compared to a rate of 50–300 per 100,000 pregnancies). Several studies have reported a twofold increased risk in women using oral contraceptives containing the progestins, gestodene (not available in the United States), drospirenone, or desogestrel, compared with women using oral contraceptives with levonorgestrel and norethindrone. Women in whom thromboembolism develops should stop using oral contraceptives, as should those at increased risk for thromboembolism associated with surgery, fracture, serious injury, hypercoagulable condition, or immobilization. Women with a known thrombophilia should not use estrogen-containing contraceptives.
C. CEREBROVASCULAR DISEASE
Overall, a small increased risk of hemorrhagic stroke and subarachnoid hemorrhage and a somewhat greater increased risk of thrombotic stroke have been found; smoking, hypertension, and age over 35 years are associated with increased risk. Women should stop using estrogen-containing contraceptives if such warning symptoms as severe headache, blurred or lost vision, or other transient neurologic disorders develop.
There is no increased risk of breast cancer in women aged 35–64 who are current or former users of oral contraceptives. Women with a family history of breast cancer or women who started oral contraceptive use at a young age are not at increased risk. Combination oral contraceptives reduce the risk of endometrial carcinoma by 40% after 2 years of use and 60% after 4 or more years of use. The risk of ovarian cancer is reduced by 30% with pill use for less than 4 years, by 60% with pill use for 5–11 years, and by 80% with use for 12 or more years. Oral contraceptives have been associated with the development of benign hepatocellular adenomas and peliosis hepatis (blood-filled cavities) (but not focal nodular hyperplasia or hepatocellular carcinoma); hepatocellular adenomas may rarely cause rupture of the liver, hemorrhage, and death. The risk of hepatocellular adenoma increases with higher dosage, longer duration of use, and older age.
Oral contraceptives may cause hypertension in some women; the risk is increased with longer duration of use and older age. Women in whom hypertension develops while using oral contraceptives should use other non-estrogen–containing contraceptive methods. However, with regular blood pressure monitoring, nonsmoking women with well-controlled mild hypertension may use oral contraceptives.
Migraine or other vascular headaches may occur or worsen with pill use. If severe or frequent headaches develop while using this method, it should be discontinued. Women with migraine headaches with aura should not use oral contraceptives due to the increased risk of stroke.
Combined oral contraceptives can impair the quantity and quality of breast milk. While it is preferable to avoid the use of combination oral contraceptives during lactation, the effects on milk quality are small and are not associated with developmental abnormalities in infants. Combination oral contraceptives should be started no earlier than 6 weeks postpartum to allow for establishment of lactation. Progestin-only pills, levonorgestrel implants, and DMPA are alternatives with no adverse effects on milk supply.
Obese and overweight women have generally been excluded from oral contraceptive trials until recently. Obesity is an independent risk factor for thromboembolic complications. However, it is important that obese women are not denied effective contraception as a result of concerns about oral contraceptive complications or efficacy. Current evidence suggests that efficacy is similar for overweight and obese women as for normal- weight individuals.
Depression may occur or be worsened with oral contraceptive use. Fluid retention may occur. Patients who had cholestatic jaundice during pregnancy may develop it while taking birth control pills.
Nausea and dizziness may occur in the first few months of pill use. Spotting or breakthrough bleeding between menstrual periods may occur; this may be helped by switching to a pill of slightly greater estrogen potency. Missed menstrual periods may occur, especially with low-dose pills. A pregnancy test should be performed if pills have been skipped or an expected menstrual period is missed. Fatigue and decreased libido can occur. Chloasma may occur, as in pregnancy, and is increased by exposure to sunlight.
1. Efficacy and methods of use
A formulation containing 0.35 mg of norethindrone alone is available in the United States. The efficacy is similar to that of combined oral contraceptives but is highly dependent on consistent use (eg, taking the pill within the same 3-hour window every day). A progestin-only pill containing drospirenone was approved by the FDA in the United States in 2019, and a desogestrel-only pill is available in several countries outside the United States. The minipill is believed to prevent conception by causing thickening of the cervical mucus to make it hostile to sperm, by causing alteration of ovum transport (which may account for the slightly higher rate of ectopic pregnancy with these pills), and by causing inhibition of implantation. Ovulation is inhibited inconsistently with this method. The minipill is begun on the first day of a menstrual cycle and then taken continuously for as long as contraception is desired; there is no “placebo week.”
The low dose of progestin and absence of estrogen make the minipill safe for women with contraindications to estrogen therapy. Because estrogen may decrease initial milk production during lactation, the progestin minipill is an ideal choice for breastfeeding women. It also is often tried by women who want minimal doses of hormones and by patients who are over age 35. The minipill lacks the cardiovascular side effects of combination pills.
3. Complications and contraindications
There are few contraindications to the minipill (ie, malabsorptive disease, current or past ischemic heart disease, and history of stroke). Minipill users often have bleeding irregularities (eg, prolonged flow, spotting, or amenorrhea); such patients may need regular pregnancy tests if there is a concern about contraceptive effectiveness. Many of the absolute contraindications and relative contraindications listed in Table 18–3 apply to the minipill; however, the contraceptive benefit of the minipill may outweigh the risks for patients who smoke, who are over age 35, or who have conditions such as superficial or deep venous thrombosis or known thromboembolic disorders or diabetes mellitus with vascular disease. Minor side effects of combination oral contraceptives such as mild headache may also occur with the minipill.
et al. Pharmacodynamics of combined estrogen-progestin oral contraceptives: 4. Effects on uterine and cervical epithelia. Expert Rev Clin Pharmacol. 2020;13:163.
et al. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. Lancet Glob Health. 2018;6:e380.
D. Update on contraceptive contraindications. J Gynecol Obstet Hum Reprod. 2019;48:297.
et al. Hormonal contraception in women with hypertension. JAMA. 2020;324:1451.
2. CONTRACEPTIVE INJECTIONS & IMPLANTS (LONG-ACTING PROGESTINS)
The injectable progestin depot-medroxyprogesterone acetate (DMPA) is approved for contraceptive use in the United States. There has been extensive worldwide experience with this method over the past 3 decades. The medication is given as a deep intramuscular injection of 150 mg every 3 months and has a contraceptive efficacy of 99.7%. A subcutaneous preparation, containing 104 mg of DMPA is also available in the United States. Common side effects include irregular bleeding, amenorrhea, weight gain, and headache. It is associated with bone mineral loss that is reversible after discontinuation of the method. Users commonly have irregular bleeding initially and subsequently develop amenorrhea. Ovulation may be delayed after its discontinuation. Contraindications are similar to those for the minipill.
A single-rod, subdermal progestin implant, etonogestrel (Nexplanon), is approved for use in the United States. Nexplanon is a 40-mm by 2-mm rod containing 68 mg of the progestin etonogestrel that is inserted in the inner aspect of the nondominant arm. It is approved for use for 3 years, but data suggest it maintains effectiveness through 5 years. Hormone levels drop rapidly after removal, and there is no delay in the return of fertility. In clinical trials, the pregnancy rate was 0.0% with 3 years of use. The side effect profile is similar to the minipill and DMPA. Irregular bleeding has been the most common reason for discontinuation.
American College of Obstetricians and Gynecologists. Practice Bulletin No. 206: Use of hormonal contraception in women with coexisting medical conditions. 2019;133:e128.
et al. Long-acting reversible contraceptive (LARCs) methods. Best Pract Res Clin Obstet Gynaecol. 2020;66:28.
et al. Barriers and solutions to improve adolescent intrauterine device access. J Pediatr Adolesc Gynecol. 2019;32:S7.
et al. From uptake to access: a decade of learning from ACOG LARC program. Am J Obstet Gynecol. 2020;222:S866.
3. OTHER COMBINED HORMONAL CONTRACEPTIVES
A transdermal contraceptive patch containing norelgestromin (150 mcg) and ethinyl estradiol (20 mcg) and measuring 20 cm2 is available. The patch is applied to the lower abdomen, upper torso, or buttock once a week for 3 consecutive weeks, followed by 1 week without the patch. It appears that the average steady-state concentration of ethinyl estradiol with the patch is approximately 60% higher than with a 35-mcg pill. However, there is currently no evidence for an increased incidence of estrogen-related side effects. The mechanism of action, side effects, and efficacy are similar to those associated with oral contraceptives, although compliance may be better. However, discontinuation due to side effects is more frequent.
A contraceptive vaginal ring that releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily (Nuva-ring) is available. The ring is soft and flexible and is placed in the upper vagina for 3 weeks, removed, and replaced 1 week later, or can be removed and replaced after 4 weeks for continuous cycling, similar to oral contraceptives. The 1-year reusable segesterone acetate/ethinyl estradiol vaginal ring (Annovera) was approved by the US FDA in 2018. The ring is worn for 3 weeks and removed for 1 week, and that pattern is repeated for a total of 13 cycles. The efficacy, mechanism of action, and systemic side effects of combined hormonal vaginal rings are similar to those associated with oral contraceptives. Ring users may experience increased vaginal discharge.
In the United States, the following IUDs are available: the levonorgestrel-releasing Mirena, Liletta, Kyleena, and Skyla IUDs and the copper-bearing TCu380A (Paragard). The mechanism of action of the copper IUD is thought to involve either spermicidal or inhibitory effects on sperm capacitation and transport. The levonorgestrel-containing IUDs also cause thickening of cervical mucus, prevent endometrial thickening, and can inhibit ovulation. IUDs are not abortifacients.
Skyla is FDA approved for use for 3 years, Kyleena for 5 years, Mirena and Liletta for 6 years, and the TCu380A for 10–12 years. These hormone-containing IUDs have the advantage of reducing cramping and menstrual flow. Mirena is FDA approved for the treatment of heavy menstrual bleeding.
The IUD is an excellent contraceptive method for most women. The devices are highly effective, with failure rates similar to those achieved with surgical sterilization. IUDs may be used in nulliparous women and adolescents. Women who are not in mutually monogamous relationships should (also) use condoms for protection from sexually transmitted diseases. Levonorgestrel-containing IUDs may have a protective effect against upper tract infection similar to that of oral contraceptives.
Insertion can be performed at any time during the menstrual cycle if pregnancy can be reasonably excluded. There is growing evidence to suggest that IUDs can be safely inserted in the immediate postabortal and postpartum periods.
Both types of IUDs (levonorgestrel-releasing and copper bearing) may be inserted up to 48 hours after vaginal delivery, or prior to closure of the uterus at the time of cesarean section. Insertion immediately following abortion is acceptable if there is no sepsis and if follow-up insertion a month later will not be possible; otherwise, it is wise to wait until 4 weeks postabortion. NSAIDs given as premedication may be helpful.
B. Contraindications and Complications
Contraindications to use of IUDs are outlined in Table 18–4.
Table 18–4.Contraindications to IUD use. ||Download (.pdf) Table 18–4. Contraindications to IUD use.
Acute or subacute pelvic inflammatory disease or purulent cervicitis
Significant anatomic abnormality of uterus
Unexplained uterine bleeding
Wilson disease or copper allergy (copper IUD)
Breast cancer (levonorgestrel IUD)
Cervical, endometrial, or gestational trophoblastic neoplasia
Active liver disease (levonorgestrel IUD)
Menorrhagia or severe dysmenorrhea (copper IUD)
A copper-containing IUD can be inserted within 5 days following a single episode of unprotected midcycle coitus as a postcoital contraceptive. An IUD should not be inserted into a pregnant uterus. If pregnancy occurs as an IUD failure, there is a greater chance of spontaneous abortion if the IUD is left in situ (50%) than if it is removed (25%). Women using an IUD who become pregnant should have the IUD removed if the string is visible. It can be removed at the time of abortion if that is desired. If the string is not visible and the patient wants to continue the pregnancy, she should be informed of the increased risk of miscarriage, infection, preterm birth, and abruption. She should be informed that any flu-like symptoms such as fever, myalgia, headache, or nausea warrant immediate medical attention for possible septic abortion.
Since the risk of ectopic pregnancy is increased in IUD users who become pregnant with an IUD in situ, clinicians should search for adnexal masses in early pregnancy and should always check the products of conception for placental tissue following abortion.
There is an increased risk of pelvic infection during the first month following insertion; however, prophylactic antibiotics are not recommended at the time of insertion since they do not appear to decrease this risk. The subsequent risk of pelvic infection appears to be primarily related to the risk of acquiring sexually transmitted infections. Infertility rates do not appear to be increased among women who have previously used the currently available IUDs. At the time of insertion, women with an increased risk of sexually transmitted diseases should be screened for gonorrhea and Chlamydia. Women with a history of recent or recurrent pelvic infection are not good candidates for an IUD.
3. Heavy menstrual bleeding or severe dysmenorrhea
The copper IUD can cause heavier menstrual periods, bleeding between periods, and more cramping, so it is generally not suitable for women who already suffer from these problems. Alternatively, the hormone-releasing IUD Mirena has been approved by the FDA to treat heavy menstrual bleeding. NSAIDs are also helpful in decreasing bleeding and pain in IUD users.
4. Complete or partial expulsion
Spontaneous expulsion of the IUD occurs in up to 10% of women during the first year of use. Any IUD should be removed if the body of the device can be seen or felt in the cervical os.
If the transcervical tail cannot be seen, this may signify unnoticed expulsion, perforation of the uterus with abdominal migration of the IUD, or simply retraction of the string into the cervical canal or uterus owing to movement of the IUD or uterine growth with pregnancy. Once pregnancy is ruled out, the clinician may probe for the IUD with sterile sound or forceps designed for IUD removal. If the IUD cannot be detected, pelvic ultrasound will demonstrate if the IUD is intrauterine (eFigures 18–13 and 18–14). Alternatively, obtain anteroposterior and lateral radiographs of the pelvis to evaluate for an extrauterine IUD. If the IUD is in the abdominal cavity, it should generally be removed by laparoscopy or laparotomy. Perforations of the uterus are less likely if insertion is performed slowly, with meticulous care taken to follow directions applicable to each type of IUD.
IUD. A: Longitudinal sonogram through the pelvis demonstrating the uterus (calipers). An IUD (Copper 7) is seen as a brightly reflective structure centrally positioned within the uterus. B: Longitudinal sonogram through the pelvis in which the IUD is abnormally positioned within the lower uterine segment and cervix. (Used, with permission, from Peter W. Callen, MD.)
IUD (Copper 7). A: Sagittal sonogram of the uterus (U) shows the echogenic parallel structure (arrow) compatible with the tubular Copper 7 imaged in its long axis. B, bladder. B: A plain film of the pelvis demonstrates the tubular device. (Reproduced, with permission, from Krebs CA, Giyanani VL, Eisenberg RL. Ultrasound Atlas of Disease Processes. Originally published by Appleton & Lange. Copyright © 1993 by The McGraw-Hill Companies, Inc.)
et al. Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020;223:177.
et al. Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial. Am J Obstet Gynecol. 2020;222:245.
et al. Increasing long-acting reversible contraceptives: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomized trial. Am J Obstet Gynecol. 2020;222:S921.
5. DIAPHRAGM & CERVICAL CAP
The diaphragm (with contraceptive jelly) is a safe and effective contraceptive method with features that make it acceptable to some women and not others. Failure rates range from 6% to 16%, depending on the motivation of the woman and the care with which the diaphragm is used. The advantages of this method are that it has no systemic side effects and gives significant protection against pelvic infection and cervical dysplasia as well as pregnancy. The disadvantages are that it must be inserted near the time of coitus and that pressure from the rim predisposes some women to cystitis after intercourse.
The cervical cap (with contraceptive jelly) is similar to the diaphragm but fits snugly over the cervix only (the diaphragm stretches from behind the cervix to behind the pubic symphysis). The cervical cap is more difficult to insert and remove than the diaphragm. The main advantages are that it can be used by women who cannot be fitted for a diaphragm because of a relaxed anterior vaginal wall or by women who have discomfort with or in whom repeated bladder infections develop with the diaphragm. However, failure rates are 9% (perfect use) and 16% (typical use) in nulliparous women and 26% (perfect use) and 32% (typical use) in parous women.
Because of the small risk of toxic shock syndrome, a cervical cap or diaphragm should not be left in the vagina for over 24 hours, nor should these devices be used during the menstrual period.
6. CONTRACEPTIVE FOAM, CREAM, FILM, SPONGE, JELLY, & SUPPOSITORY
These products are available without prescription, are easy to use, and have typical failure rates of 10–22%. All contain the spermicide nonoxynol-9, which also has some viricidal and bactericidal activity. Nonoxynol-9 does not appear to adversely affect the vaginal colonization of hydrogen peroxide–producing lactobacilli. The FDA requires products containing nonoxynol-9 to include a warning that the products do not protect against HIV or other sexually transmitted diseases and that use of these products can irritate the vagina and rectum and may increase the risk of HIV acquisition from an infected partner. A different on-demand vaginal contraceptive, a vaginal pH regulator gel containing lactic acid–citric acid–potassium bitartrate (commercial name Phexxi), was FDA approved for use in the United States in 2020. The supporting clinical trial estimated 27.5 pregnancies per 100 woman-years.
Phexxi—a nonhormonal contraceptive gel. Med Lett Drugs Ther. 2020;62:129.
The male condom of latex, polyurethane or animal membrane affords protection against pregnancy—equivalent to that of a diaphragm and spermicidal jelly; latex and polyurethane (but not animal membrane) condoms also offer protection against many sexually transmitted diseases, including HIV. When a spermicide, such as vaginal foam, is used with the condom, perfect use failure rate is approximately 2% and typical use, 15%. The disadvantages of condoms are dulling of sensation and spillage of semen due to tearing, slipping, or leakage with detumescence of the penis.
Two female condoms, one made of polyurethane and the other of synthetic nitrile, are available in the United States. The reported failure rates range from 5% to 21%; the efficacy is comparable to that of the diaphragm. These are the only female-controlled method that offers significant protection against both pregnancy and sexually transmitted diseases.
et al. Male and female condoms: their key role in pregnancy and STI/HIV prevention. Best Pract Res Clin Obstet Gynaecol. 2020;66:55.
8. CONTRACEPTION BASED ON AWARENESS OF FERTILE PERIODS
These methods are most effective when the couple restricts intercourse to the post-ovular phase of the cycle or uses a barrier method at other times. Well-instructed, motivated couples may be able to achieve low pregnancy rates with fertility awareness methods. Examples of some of these include monitoring cervical mucus changes, basal body temperature fluctuations, and menstrual cycle calculations to avoid having intercourse on fertile days. However, properly done randomized clinical trials comparing the efficacy of most of these methods with other contraceptive methods do not exist.
A. "Symptothermal" Natural Family Planning
The basis for this approach is patient-observed increase in clear elastic cervical mucus, brief abdominal midcycle discomfort ("mittelschmerz"), and a sustained rise of the basal body temperature about 2 weeks after onset of menstruation (eFigure 18–15). Unprotected intercourse is avoided from shortly after the menstrual period, when fertile mucus is first identified, until 48 hours after ovulation, as identified by a sustained rise in temperature and the disappearance of clear elastic mucus.
Typical basal body temperature and plasma hormone concentrations during a normal 28-day human menstrual cycle. M, menstruation; IRPhMG, international reference standard for gonadotropins. (Reproduced, with permission, from Midgley AR. In: Human Reproduction, Hafez ESE, Evans TN [editors]. Harper & Row, 1973.)
B. Basal Body Temperature Method
This method indicates the safe time for intercourse after ovulation has passed. The temperature must be taken immediately upon awakening, before any activity. A slight drop in temperature often occurs 12–24 hours before ovulation, and a rise of about 0.4°C occurs 1–2 days after ovulation. The elevated temperature continues throughout the remainder of the cycle. Data suggest that the risk of pregnancy increases starting 5 days prior to the day of ovulation, peaks on the day of ovulation, and then rapidly decreases to zero by the day after ovulation.
This fertility awareness method requires the use of a set of beads that reminds the couple to avoid intercourse (or use a barrier method of contraception) during days 8 through 19 of the menstrual cycle. The beads are in a circle and color-coded to show the days when a woman is likely to become pregnant and the days that are "safe" during the cycle. A movable ring is repositioned to a new bead each day, starting on the first day of menses. In a small multicenter trial, the perfect use failure rate was 5% and the typical use failure rate was 12%. The method is applicable to women with a history of menstrual cycles between 29 and 32 days.
9. EMERGENCY CONTRACEPTION
Emergency contraception can be used to decrease the risk of pregnancy after intercourse but before the establishment of pregnancy. These methods should be started as soon as possible and within 120 hours after unprotected coitus: (1) Levonorgestrel, 1.5 mg orally as a single dose (available in the United States prepackaged as Plan B and available over-the-counter [OTC] for women aged 17 years and older), has a 1–2% failure rate when taken within 72 hours. It remains efficacious up to 120 hours after intercourse, though less so compared with earlier use. (2) If the levonorgestrel regimen is not available, a combination oral contraceptive containing ethinyl estradiol and levonorgestrel given twice in 12 hours may be used. At least 20 brands of pills may be used in this way. For specific dosages and instructions for each pill brand, consult “not-2-late” at http://ec.princeton.edu/. Used within 72 hours, the failure rate of these regimens is approximately 3%, but antinausea medication is often necessary. (3) Ulipristal acetate, a selective progesterone receptor modulator, taken orally as a single 30 mg dose, has been shown to be more effective than levonorgestrel, especially when used between 72 and 120 hours, particularly among overweight and obese women. It is available by prescription in the United States but was withdrawn from the market in the European Union and Canada in 2020 due to rare reports of serious drug-induced liver injury. Patients should wait 5 days after taking ulipristal to start or restart a hormonal contraceptive method. (4) Copper IUD insertion within 5 days after one episode of unprotected midcycle coitus will also prevent pregnancy. Copper IUD use for emergency contraception is the most effective available method, with first cycle pregnancy rates of 0.1%. All victims of sexual violence should be offered emergency contraception.
Information on clinics or individual clinicians providing emergency contraception in the United States may be obtained by calling 1-888-668-2528.
et al. The efficacy of intrauterine devices for emergency contraception and beyond: a systemic review update. Int J Womens Health. 2019;11:471.
et al. Interventions for emergency contraception. Cochrane Database Syst Rev. 2019;1:CD001324.
KK; Committee on Adolescence. Emergency contraception. Pediatrics. 2019;144:e20193149.
In the United States, sterilization is the most popular method of birth control for couples who want no more children. Although sterilization is reversible in some instances, reversal surgery for both women and men is costly, complicated, and not always successful. Therefore, patients should be counseled carefully before sterilization and should view the procedure as permanent.
Female sterilization procedures include laparoscopic bipolar electrocoagulation, salpingectomy, plastic ring application on the uterine tubes, or minilaparotomy with tubal resection. Salpingectomy may be preferred for the added benefit of decreasing ovarian cancer risk. The advantages of laparoscopy are minimal postoperative pain, small incisions, and rapid recovery. The advantages of minilaparotomy are that it can be performed with standard surgical instruments under local or general anesthesia. However, there is more postoperative pain and a longer recovery period. The cumulative 10-year failure rate for all methods combined is 1.85%, varying from 0.75% for postpartum partial salpingectomy and laparoscopic unipolar coagulation to 3.65% for spring clips; this fact should be discussed with women preoperatively. Some studies have found an increased risk of menstrual irregularities as a long-term complication of tubal ligation, but findings in different studies have been inconsistent. A method of trans-cervical sterilization, Essure, involving placement of an expanding nickel-titanium microcoil into the proximal uterine tube under hysteroscopic guidance, was approved by the FDA in 2002. However, as of 2018, Essure was no longer marketed due to concerns related to complications and side effects reported by users.
Male sterilization by vasectomy is a safe, simple procedure in which the vas deferens is severed and sealed through a scrotal incision under local anesthesia. Long-term follow-up studies on vasectomized men show no excess risk of cardiovascular disease. Despite past controversy, there is no definite association of vasectomy with prostate cancer.
Refer to experienced clinicians for etonogestrel subdermal (Nexplanon) insertion, IUD insertion, tubal occlusion or ligation, therapeutic abortion, or vasectomy.
ACOG Practice Bulletin No. 208 Summary: Benefits and risks of sterilization. Obstet Gynecol. 2019;133:592.
et al. Expedited scheduling of interval tubal ligation: a randomized controlled trial. Obstet Gynecol. 2019;134:1178.
et al. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019;220:8.
Since the legalization of abortion in the United States in 1973, the related maternal mortality rate has fallen markedly because illegal and self-induced abortions have been replaced by safer medical procedures. Abortions in the first trimester of pregnancy are performed by vacuum aspiration under local anesthesia or with medical regimens. Dilation and evacuation, a variation of vacuum aspiration is generally used in the second trimester. Techniques utilizing intra-amniotic instillation of hypertonic saline solution or various prostaglandins regimens, along with medical or osmotic dilators are occasionally used after 18 weeks. Several medical abortion regimens using mifepristone and multiple doses of misoprostol have been reported as being effective in the second trimester. Overall, legal abortion in the United States has a mortality rate of less than 1:100,000. Rates of morbidity and mortality rise with length of gestation. In the United States, more than 60% of abortions are performed before 9 weeks, and more than 90% are performed before 13 weeks’ gestation; only 1.2% are performed after 20 weeks. If abortion is chosen, every effort should be made to encourage the patient to seek an early procedure. In the United States, while numerous state laws limiting access to abortion and a federal law banning a rarely used variation of dilation and evacuation have been enacted, abortion remains legal and available until fetal viability (definition varies by state), under Roe v. Wade.
Complications resulting from abortion include retained products of conception (often associated with infection and heavy bleeding), uterine perforation, and unrecognized ectopic pregnancy. Immediate analysis of the removed tissue for placenta can exclude or corroborate the diagnosis of ectopic pregnancy. Women who have fever, bleeding, or abdominal pain after abortion should be examined; use of broad-spectrum antibiotics and reaspiration of the uterus are frequently necessary. Hospitalization is advisable if postabortal endometritis requires administration of intravenous antibiotics. Complications following illegal abortion often need emergency care for hemorrhage, septic shock, or uterine perforation.
Prophylactic antibiotics are recommended prior to surgical abortion; for example, a single dose of doxycycline 200 mg orally can be given 1 hour before the procedure. Rh immune globulin should be given to all Rh-negative women following abortion. Contraception should be thoroughly discussed, and contraceptive supplies or pills provided at the time of abortion. There is growing evidence to support the safety and efficacy of immediate postabortal insertion of IUDs.
Mifepristone (RU 486) is approved by the FDA as an oral abortifacient at a dose of 200 mg orally on day 1, followed by misoprostol 800 mcg buccally 24–48 hours later. The WHO recommended regimen includes mifepristone orally followed by misoprostol vaginally, sublingually, or buccally. These combinations are 93% successful in terminating pregnancies of up to 70 days’ gestation with few complications. There is a 5–10% risk of incomplete abortion requiring curettage and approximately 1% risk of requiring intervention for excessive bleeding. Overall, the risk of uterine infection is lower with medical than with surgical abortion.
et al. Effectiveness, safety and acceptability of self-assessment of the outcome of first-trimester medical abortion: a systematic review and meta-analysis. BJOG. 2019;126:1536.
et al. Risk of complication during surgical abortion in obese women. Am J Obstet Gynecol. 2018;218:238.
et al. Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks’ gestation: a systematic review with meta-analyses. Am J Obstet Gynecol. 2020;222:551.