TITLE: FEMALE CONTRACEPTION UPDATE
AUTHORS: SHAKUNTALA KOTHARI, MD -- Department of General Internal Medicine
  MARISHA NEWTON, MD -- Department of General Internal Medicine
PUBLISHED: JULY 13, 2005
    
Unintended pregnancy is a major women's health problem. In the United States, about 50% of all pregnancies are unplanned. Fifty-three percent of women were using some method of contraception when these pregnancies occurred.1 This article will cover female contraceptive methods, sterilization, and emergency contraception approved for use in the United States.
PATIENT ELIGIBILITY
Contraceptives may be used continuously at any age at which a woman is at risk of pregnancy. Oral contraceptive pills need be stopped only 2 weeks before major elective surgery or after serious accidents that may necessitate immobilization, with the goal of decreasing the risk of deep vein thrombosis.
PRESCRIBING CONTRACEPTIVES

The choice of contraceptive method is determined by the woman's health, frequency of sexual activity, number of sexual partners, and desire for permanence, as well as the efficacy of the contraceptive method (Table 1). There are several contraindications for combination hormonal contraceptives. They include previous thromboembolic event or stroke, liver disease, history of estrogen-dependent tumor, undiagnosed abnormal uterine bleeding, hypertriglyceridemia, and smoking in women older than age 35.2

Women with one or more contraindications should not be prescribed combination hormonal contraceptives. Use of combination contraceptives by diabetic women should be limited to those who do not smoke, are younger than 35, and are otherwise healthy. Progesterone injections are safer in women who suffer from migraines, headaches, lupus, sickle cell anemia, hypertension, or diabetes with vascular disease, or those older than age 35.

Specific screening before prescribing contraceptives is not mandatory. However, patients at risk for high blood pressure should undergo screening before initiation. It is recommended that 13 cycles of contraceptives be prescribed so that ready access is assured. At the initial visit, a 3-month follow up is suggested for counseling and reinforcement. Women should be counseled about the efficacy, side effects, and correct methods of use; about the signs and symptoms that require return to the physician; and about protection against sexually transmitted diseases (STDs). A woman should then return yearly.

MECHANISM OF ACTION
OF HORMONAL CONTRACEPTIVES
Hormonal contraceptives can include combination estrogen and progestin and progestin only. Estrogen effects include inhibition of ovulation and prevention of follicular maturation through suppression of ovarian steroid production and possibly decreased responsiveness to gonadotropin-releasing hormone. Conversely, progestin leads to changes in the endometrium that make implantation less likely, increased thickness of cervical mucus that makes sperm penetration difficult, and impairment of normal tubal mobility.2 Most progestins are derivatives of testosterone and thus will have residual androgenic activity. It is this androgenic aspect of progestins that causes many of the side effects and metabolic complications.
ORAL CONTRACEPTIVES

Combination Pills:

These are usually packaged for 21-day or 28-day cycles. They include monophasic pills that contain set doses of estrogen and progestin in each of the hormonally active pills. Biphasic pills contain fixed doses of estrogen and increasing doses of progestin. Triphasic pills contain varying doses of estrogen and progestin. Newer progestins have less effect on carbohydrates and lipid metabolism and are more effective in reducing acne and hirsutism in hyperandrogenic women. Newer progestins include spironolactone analogues and continuous pills.

Drospirenone/ethinyl estradiol (Yasmin) is a combined oral contraceptive containing drospirenone and ethinyl estradiol. Drospirenone is a newer progestin that is a spironolactone analogue; it is anti-androgenic and anti-mineralocorticoid. The anti-mineralocorticoid effect of drospirenone prevents excess accumulation of water and sodium in the body. Women taking nonsteroidal anti-inflammatory agents, potassium-sparing diuretics, acetylcholinesterase inhibitors, angiotensin II receptor antagonists, and heparin should not take Yasmin. Renal and adrenal insufficiencies as well as hepatic dysfunction are also contraindications. Yasmin may lead to hyperkalemia.

Levonorgestrel/ethinyl estradiol (Seasonale) is a 91-day oral contraceptive regimen that contains levonorgestrel (progestin) and ethinyl estradiol for 12 weeks (84 days), followed by 1 week of placebo. Women have only four menses per year.

Side Effects
Dizziness, weight gain, nausea, spotting, amenorrhea, and breast tenderness are among the most common side effects.

Advantages
There is no inhibition of spontaneity, and the contraceptive effects end after 3 months of stopping the pill.

Precautions
Pills must be taken the same time each day, require a prescription, provide no protection against STDs, and need a barrier method for the first 7 days of use. Certain drugs such as rifampin, amoxicillin, metronidazole, tetracyclines, and cephalexin may decrease the effectiveness of the pills.

Progestin-Only Pills
Progestin-only pills (or mini-pills) are associated with more break-through bleeding than combination pills and have slightly higher failure rates.

Side Effects
Irregular bleeding, weight gain, and breast tenderness are the most common.

Advantages
Progestin-only pills are a good option for patients who need to avoid estrogen (Figure 1).

Precautions
Precautions are similar to those for combined oral contraceptives. Mini-pills offer less protection against ectopic pregnancy.

Noncontraceptive Benefits
of Oral Contraceptives:

Oral contraceptives have been successfully used in the treatment of hyperandrogenism, including idiopathic hirsutism and polycystic ovarian syndrome. Levonorgestrel-containing preparations may aggravate these problems and should therefore be avoided in these cases. Oral contraceptives are also used in the treatment of dysmenorrhea, menorrhagia, hypothalamic amenorrhea, hormone replacement in women with primary hypogonadism, and premenstrual syndrome. They lead to lower risk of iron deficiency anemia caused by increased menstrual flow; ectopic pregnancy in the case of combination contraceptives; ovarian cysts; postmenopausal hip fractures in women who used combined contraceptives in their 30s; benign breast disease; ovarian cancer; and endometrial cancer. Preparations containing low doses of estrogen (20 µg) are often used in perimenopausal women. They help to relieve vasomotor flushing, but symptoms unfortunately recur during the placebo period.

INJECTABLE CONTRACEPTION

Depot Medroxyprogesterone Acetate:
Depot medroxyprogesterone acetate (Depo-Provera) is a progesterone that prevents ovulation in addition to causing changes in cervical mucus and the endometrium. It is given as an injection in the buttocks or upper arm within 5 days after the beginning of the normal menstrual cycle and is repeated every 3 months. It is more effective than oral contraceptives.

Side Effects
Irregular bleeding, weight gain, headache, mood change, abdominal pain, dizziness, weakness or fatigue, and breast tenderness. After 1 year of use, 50 % of women have amenorrhea.3 This is not harmful, and periods return shortly after the drug is stopped.

Advantages
It is safe, reversible, maintains spontaneity, and has noncontraceptive benefits similar to those of oral contraceptives. Ovulation is suppressed for at least 14 weeks, so delay of up to 2 weeks in the next injection is acceptable. Women with a lapse of more than 14 weeks should have pregnancy ruled out.

Precautions
Precautions include spotting, especially during the first 3 months, and lack of protection against STDs. Fertility usually returns within 6 to 9 months after stopping, but can take up to 18 months.3 Depot medroxyprogesterone acetate may also result in bone loss.

Lunelle
This is an injectable combination contraceptive that will not be discussed, as it is no longer available on the US market because of concerns about its efficacy.

IMPLANTABLE CONTRACEPTION
Implantable contraception such as Norplant will not be discussed because, as of 2002, it is no longer being manufactured. Women should be encouraged to contact their physician near the end of the 5-year expiration date of their Norplant system.
TRANSDERMAL CONTRACEPTION

The transdermal patch (Ortho Evra) consists of three layers. The middle layer contains norelgestromin and ethinyl estradiol. The inner layer is an adhesive and the outer is a protective cover. The patch releases 150 µg of norelgestromin and 20 µg of ethinyl estradiol daily. The first patch should be applied within the first 5 days of the menstrual cycle, and backup contraceptives should be used concomitantly for 7 days. A new patch should be applied every week for 3 weeks, followed by 1 patch-free week.

Side Effects
Similar to those of combination oral contraceptives.

Advantages
The patch provides a steady release of hormones. Application sites include the buttocks, abdomen, outer arms, and torso, except the breasts.

Precautions
The patch may completely detach in 2% to 6% of cases. If it is replaced within 48 hours, no backup contraception is needed. If the patch-free interval exceeds 2 days, pregnancy should be ruled out, a new patch should be placed, and a backup contraceptive method should be used for 7 days. In case of skin irritation, the patch should be removed and a new patch applied to another site. Women weighing more than 198 pounds should not use the patch because its effectiveness is reduced. It offers no protection against STDs.

HORMONAL RING

The NuvaRing is a nonbiodegradable, flexible vaginal ring made of a polymer of ethylene vinyl acetate and magnesium stearate. The outer diameter of the ring is 54 mm, and the cross-sectional diameter is 4 mm. It releases 120 µg of etonogestrel and 15 µg of ethinyl estradiol daily. The ring is left in place for 3 weeks, followed by 1 ring-free week.

Side Effects
Vaginal discharge, vaginitis, and irritation may occur. Side effects are otherwise similar to those of oral combination pills.

Advantages
The ring can be inserted at any time during the first 5 days of the menstrual cycle. A new ring should be inserted each month. The hormonal ring provides good cycle control.

Precautions
If the ring is expelled during the first 3 weeks of use, it should be washed with lukewarm water and then replaced. If the ring-free interval is longer than 3 hours, a backup contraceptive method should be used concomitantly for 7 days. The ring should never be left in place for more than 4 weeks. If left in place, pregnancy should be ruled out before a new ring is inserted, and a backup method should be used for 7 days after inserting a new ring. It provides no protection against STDs.

INTRAUTERINE DEVICES
There are currently two intrauterine devices ( IUDs) on the market, the copper Paragard T 380A and the levonorgestrel system, Mirena. Today's IUDs are safe and slightly more effective than oral contraceptives (Table 1). The copper IUD is a T-shaped device made of soft, flexible plastic with threads on the end that extend from the cervix and into the upper vagina. Copper IUDs induce a foreign-body reaction in the endometrium, leading to inflammation that prevents viable sperm from reaching the fallopian tubes.

The levonorgestrel-releasing IUD is a T-shaped polyethylene device. The frame is 32 mm in both horizontal and vertical directions. The vertical stem contains a mixture of silicone and 52 mg of levonorgestrel surrounded by a silastic capsule. The device releases 25 µg of levonorgestrel daily. It has an effective life of 5 years. It can be inserted within the first 7 days of onset of menstruation. This device causes changes in the lining of the uterus so that the fertilized egg cannot implant, and it thickens the cervical mucus to make sperm entry difficult.

Side Effects
Side effects include cramping during insertion, bleeding, pelvic inflammatory disease, and perforation of the uterus.

Advantages
Spontaneity is maintained, and there is marked reduction in menstrual blood loss and dysmenorrhea. Copper IUDs last for 10 years; the Mirena system is effective for 5 years. Fertility returns rapidly after discontinuation of IUDs.
Precautions. Expulsion of the copper IUD can occur in 5% of women during the first year. Expulsion rates for Mirena are a little higher than for copper IUDs. Each month, the location of the threads of the copper IUD should be checked by insertion of the fingers and the physician should be notified if they are not felt. There is a mildly increased risk of ectopic pregnancy. Ovarian cysts are three times more common in users of this device. Twenty percent of women develop amenorrhea by the end of the first year of use. The risk of pelvic infection is higher during the first 20 days of Mirena insertion. There is also no protection against STDs.

BARRIER CONTRACEPTION

Prescription barrier methods include the diaphragm, cervical caps, and shields (Table 1). They cover the cervix and prevent sperm entry into the cervix. These devices are less effective than hormonal forms of contraception. The female condom and spermicides are both non-prescription barrier methods. Female condoms are similar in efficacy to other barrier methods but have the benefit of some protection against STDs. Spermicides should be used in combination with other barrier methods.

 

 

 

Table 1:
Selected Barrier Contraception Methods
Method
Left in Place After
Intercourse (Hours)
Remove
Within (Hours)
Diaphragm
6
24
Prentif (latex)
cervical cap
8
48
FemCap (silicone) cervical cap
6
48
Lea's shield
8
48

Diaphragm:

This is a dome-shaped rubber disk with a flexible rim. The effectiveness depends on the proper fit as determined by the physician.

Cervical Cap:

This is smaller than a diaphragm. It fits securely in the vagina, covering the cervix, and must be fitted by a physician. Two types are available. The latex cervical cap (Prentif) has a firm, flexible rim. The silicone FemCap comes in three sizes, ranging from 22 mm to 30 mm. It is reusable for 2 years.

Cervical Shield:

This is a dome-shaped disk made of silicone. It has a one-way valve that creates suction by venting trapped air between the shield and cervix. It acts by preventing sperm entry. It also has a strap for easy removal. Lea's shield is the only one available. Spermicide should be applied to the device before insertion. Lea's shield should be replaced annually.

Side Effects
Side effects of the above barrier methods include vaginal irritation; allergic reactions to latex, silicone, or spermicide; urinary tract infections; and the rare risk of toxic shock if left in place too long.

Advantages
They are safe, effective, reusable, and have no effect on the menstrual cycle.

Precautions
These methods are less effective than hormonal contraception and provide no protection against STDs. Use of cervical shields may lead to falsely abnormal

Papanicolaou Tests
Resizing should be done after abdominal or pelvic surgery, after any pregnancy longer than 14 weeks, and after any significant weight change.

To protect against pregnancy, the devices should be left in place for a certain minimum of time after intercourse and then removed, to decrease risk of infection.

Spermicides:

Spermicides contain chemicals that kill or damage sperm. They come in the form of creams, gels, films, suppositories, and tablets.

Side Effects
Irritation, allergic reaction, and urinary tract infections are some side effects.

Advantages
They are inexpensive and do not require a prescription.

Disadvantages
Spermicides offer no STD protection, are less effective, and should supplement other barrier methods.

Contraceptive Sponge:

Sponges will not be discussed as they are no longer available in the United States. They were taken off the market because of a contaminated manufacturing site, and the company has not reapplied for approval.

Female Condoms:

The Reality female condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm, while the other remains outside, covering the labia.

Side Effects
Side effects include irritation and allergic reactions.

Advantages
The female condom may offer some protection against STDs, but for highly effective protection, male latex condoms should be used instead.

Precautions
The male and female condoms should not be used at the same time because they will not both stay in place.

FEMALE STERILIZATION

Hysteroscopic Sterilization:

Hysteroscopic sterilization (Essure) is a new method of sterilization that uses a transcervical approach. The microinsert consists of a stainless-steel inner coil, an elastic outer coil, and polyethylene fibers. The coil is inserted into the uterine end of the fallopian tube using a hysteroscopic technique. The outer coil expands to anchor the insert. The polyethylene fibers expand and cause inflammation and extensive fibrosis, resulting in permanent occlusion of the fallopian tubes by 12 weeks. Women should thus use a backup method for 12 weeks.

Side Effects
They include pain after insertion and a small increased risk of ectopic pregnancy.

Advantages
Women do not have to worry about pregnancy and the side effects of contraceptives.

Precautions
Hysterosalpingography should be done at the end of 12 weeks to confirm tubal occlusion. Failure to correctly place the microinserts may lead to expulsion.

Tubal Ligation:

Tubal ligation is a surgical procedure requiring anesthesia in which the fallopian tubes are cut or tied. The surgery takes about 30 minutes.

Advantage
The procedure does not affect sexual activity or the menstrual cycle.

Precautions
There is a risk of bleeding from the site, infection side effects from anesthesia, bowel or bladder injury, and injury to the skin or bowel. In addition, there is slightly increased risk of ectopic pregnancy.

NATURAL FAMILY PLANNING

Sperm can live in the female reproductive tract for up to 7 days, whereas the egg lives for 1 day. Safe days occur 2 days after ovulation and continue until the next menses. This knowledge forms the basis of natural family planning.

Ovulation Method
The days just before and after ovulation are determined by checking cervical mucus. Mucus is stretchy and clear at the time of ovulation.

Symptothermal Method
Daily temperature is recorded on a chart. Body temperature rises 2 days before ovulation. Consistency of cervical mucus is also monitored.

Rhythm Method
This method is based on calendar calculations of previous menstrual cycles. This method does not allow for normal changes in the menstrual cycle and is not as reliable as the ovulation or symptothermal method. This method is not recommended. Women who have no variation in the length of their menstrual cycle can use the rhythm method to know when they are ovulating (14 days before the start of menses).

Lactation Amenorrhea Method
This is a contraceptive method based on natural postpartum infertility, when a women is amenorrheic and exclusively breastfeeding. The infant's suckling suppresses production of hormones. All three criteria-exclusive or near-exclusive breastfeeding, no menses since delivery, and less than 6 months postpartum-must be satisfied to effectively use this method.

EMERGENCY ORAL CONTRACEPTION

Plan B, or the levonorgestrel regimen, is the only emergency contraceptive pill regimen currently approved in the United States. It consists of two 0.75-mg levonorgestrel pills taken 12 hours apart. The first pill should be taken as soon as possible within 72 hours of unprotected intercourse. It is currently available by prescription only. The Yuzpe regimen, marketed as Preven, is no longer available in the United States.

Advantages
Emergency contraceptive pills are not teratogenic. Thus, a pregnancy test is not required before treatment. The only indication for emergency contraception is unprotected intercourse. Failure rate is 0.4% when treatment is initiated within 24 hours and 2.7 % when treatment is initiated 48 to 72 hours after intercourse.4

Precautions
Plan B should not be used in cases of known or suspected pregnancy, hypersensitivity to components, or undiagnosed abnormal vaginal bleeding. Major side effects include nausea and vomiting.

CONCLUSION

The range of available contraceptive options has increased markedly over the past 5 years. This progress is likely to continue as consumers seek safer, more effective contraceptive methods. Improved counseling and knowledge should lead to more consistent and correct use of contraceptives and thus decreased numbers of unplanned pregnancies.

REFERENCES
  1. Rawlins S, Smith D. Innovative contraception: new options in hormonal contraception. Am J Nurse Practitioners. 2002;6:9-28.

  2. Burkman RT. Oral contraceptives: current status. Clin Obstet Gynecol. 2001;44:62-72.

  3. Kaunitz AM. Injectable long-acting contraceptives. Clin Obstet Gynecol. 2001;44:73-91.

  4. Thomas MA. Postcoital contraception. Clin Obstet Gynecol. 2001;44:101-105.

  5. Gallo MF, Grimes DA, Schulz KF. Cervical cap versus diaphragm for contraception. Cochrane Database Syst Rev. 2002, I: CD003551.

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