Post Coital Glow
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Post Coital Glow
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This chapter should be cited as follows:
Stika, C, Glob. libr. women's med ., (ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10391
Catherine S. Stika, MD Instructor, Obstetrics and Gynecology, Northwestern University Medical Schhool, Chicago, Illinois
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Nearly 3.5 million American women become pregnant unintentionally each year. 1 More than half of all accidental pregnancies occur as a result of unprotected intercourse; however, almost as many women conceive when contraception fails. Contraceptive failure takes a variety of forms: a condom ruptures; a diaphragm or cervical cap dislodges; an intrauterine device (IUD) is expelled; or birth control pills are lost, forgotten, or poorly absorbed in the presence of gastrointestinal hypermotility. Among unintentional pregnancies are an unknown number that follow rape or incestual coitus. Regardless of the initiating circumstances, more than half of all unintended pregnancies in the United States end in elective abortion. 2 If emergency postcoital contraception were requested or prescribed more frequently, the number of unintended pregnancies in the United States could potentially be reduced by 1.7 to 2.3 million. 3
In the centuries before the development of hormonal contraception in the 1960s, women fashioned crude barriers to prevent entrance of sperm into the upper genital tract or used potions and remedies of an often-dubious nature to prevent pregnancy. More creative methods included a pessary made with crocodile dung and honey in ancient Egypt; a pessary of colocynth pulp, bryony, sulfur, iron scoria, scammony, and cabbage seeds in 12th-century Persia; and a douche containing a sulfate mixture of zinc, alum, and perlash in 19th-century America. Postcoital douches were also made from infusions of substances as diverse as white oak bark, red rose leaves, nutgalls, wine, and fennel bulb or caustic household agents including disinfectants, mercuric chloride, vinegar, lemon juice, alum, pomegranate juice, and even cola soda. 4
The extent to which these historic and even recent concoctions were used for “regular” as opposed to “emergency” contraception is speculative, just as is their efficacy. During the past 3 decades, however, a variety of more sophisticated and pharmacologically appropriate methods have been advocated for use in emergency postcoital situations. These differ in a number of ways: the nature of the agent, mechanism of action, side effects, and cost. They are similar, however, in two ways: all are underused and all are highly effective if used within a narrow “window of opportunity” after unprotected intercourse. Despite U.S. Food and Drug Administration (FDA) approval of two different hormonal postcoital contraceptives, Preven Emergency Contraceptive Kit in 1998 and Plan B in 1999, many physicians, the general public, and women in particular know comparatively little about their existence. This chapter addresses these issues.
Although estrogens from ovarian extracts were originally used in the 1920s for their ability to prevent pregnancy, 5 the first study of high-dose oral estrogen for emergency postcoital contraception was published in 1968 by Haspels and the International Planned Parenthood. 6 Although many of the early studies used diethylstilbestrol (DES), other equivalent estrogen regimens advocated ethinyl estradiol, conjugated estrogens, and estrone ( Table 1 ). When initiated within 72 hours of unprotected intercourse, therapy with DES had a reported failure rate of only 0.0% to 2.4%. 7 Failure rates were similarly low with other high-dose estrogen regimens. In a review of four published studies using ethinyl estradiol at daily doses between 2 and 5 mg for 5 days, Fasoli and coworkers 11 calculated an aggregate pregnancy rate of 0.6%, and a failure rate of 1.6% was reported with the conjugated estrogens. 12
Table 1. Dosing Regimens for Diethylstilbesterol (DES) and Other Types of Estrogen-Only Emergency Contraception
However, troublesome side effects made this form of emergency contraception particularly unpleasant. In a study of 3016 women treated with DES, nausea was reported in 53% of women and vomiting in 21%. 7 Indeed, nausea was so common with this regimen that many physicians routinely prescribed an antiemetic to be taken with the first DES dose. Other reported side effects included the occurrence of menorrhagia with the next menses in 20%, mastalgia in 10%, and occasional headaches and dizziness. 7 Compliance with this regimen was often difficult, mainly because of the significant side effects and the 5 required days of treatment.
The use of DES for postcoital contraception was approved by the FDA in 1975. However, as physician and patient awareness increased regarding the relation between fetal DES exposure and vaginal adenocarcinoma and genital malformation or dysfunction in both female and male offspring, this regimen fell into disfavor. The FDA has since discontinued its approval of DES for postcoital contraception. 13
After the loss of FDA approval for the postcoital contraception indication for DES, there was no officially sanctioned emergency contraception in the United States until Preven (Gynétics, Sommerville, NJ) was approved in 1998. In the intervening years, the off-label use of oral contraceptive pills, known as the Yuzpe method, was popularized. This regimen consists of two oral contraception pills, each containing ethinyl estradiol 50 μ g and dl-norgestrel 0.5 mg, administered within 72 hours of unprotected intercourse with a second dose repeated 12 hours later. This provides a total dosage of 200 μ g ethinyl estradiol and 2 mg dl-norgestrel. To prescribe the Yuzpe regimen, physicians and pharmacists had to break apart an Ovral monthly packet and repackage four tablets. A prescription for Preven provides equivalent medication (four tablets) with patient instructions and a urine pregnancy test in an individually packaged kit. The only difference between a Preven tablet and Ovral is that the dl-norgestrel 0.5 mg has been replaced by levonorgestrel 0.25 mg. Because the levonorgestrel enantiomer is the bioactive component of dl-norgestrel, the two products are pharmacodynamically equivalent. Therefore, results of research with the Yuzpe regimen are applicable to current use of Preven.
After preliminary studies in 1974 14 and 1977, 15 Yuzpe published his seminal multicenter Canadian report advocating postcoital use of combined ethinyl estradiol/dl-norgestrel oral contraceptive pills in 1982. 16 Numerous confirmatory studies followed, and this regimen rapidly replaced DES and other high-dose estrogens as the most commonly prescribed form of emergency contraceptive. 17 , 18 , 19 Compared to high-dose estrogen therapy, the Yuzpe method offered a 125-fold reduction in ethinyl estradiol content and a decrease in the overall length of drug therapy.
A particular appeal of the Yuzpe method was that it used readily available agents that enjoyed high physician and public confidence. Although Ovral was probably the most frequently prescribed medication for emergency contraception, other less-studied alternative regimens available in the United States included the following 20 : (1) four oral contraceptive tablets, each containing ethinyl estradiol 30 μ g and levonorgestrel 0.125 mg repeated 12 hours later (possible medications: the yellow tablets [third week] of either Tri-Levlen or Triphasil) or (2) four oral contraceptive tablets each containing 30 μ g of ethinyl estradiol and 0.15 mg of levonorgestrel (or dl-norgestrel 0.3 mg), repeated 12 hours later (possible medications: Nordette, Levlen, or Lo/Ovral).
In a pooled analysis of 24 studies using the Yuzpe method in 9588 women, the calculated average failure rate was 1.84% (range, 0.0% to 7.44%). 10 The true effectiveness of this method in preventing pregnancy is difficult to determine and can only be estimated on the basis of predicted pregnancy rates. The risk of pregnancy with one act of intercourse ranges from 0.0% to 26% depending on the day of intercourse relative to ovulation. The risk is highest during the 3 days before ovulation and on the day of ovulation itself. During this window, estimated conception rates range from 15% to 26%. 21 , 22 Reviewing studies based on the use of postcoital oral contraceptives, Trussell and Stewart 23 calculated that the Yuzpe method could reduce the risk of pregnancy by 75% and would have a failure rate of approximately 25%. Garcia and associates 24 hypothesized that failures of emergency contraception occurred because: (1) the woman had multiple sexual exposures during the month, (2) a pregnancy was already established at the time of administration, (3) inadequate medication was prescribed, or (4) the woman did not take the pills as prescribed or discontinued them because of nausea and vomiting.
There is some controversy among authors as to the importance of the timing of initiation of emergency oral contraceptive therapy. Most authors advocate starting the first dose of the Yuzpe method within 72 hours of unprotected intercourse. Beginning therapy as soon as possible, even within that window, may also affect pregnancy rates. Kane and Sparrow 25 found that women who started treatment within 12 to 24 hours of unprotected intercourse had improved success rates when compared to women who delayed therapy until 48 to 72 hours. Improved success rates with early administration were also seen in the 1993 study by Ho and Kwan 26 comparing levonorgestrel with the Yuzpe method as well as in the World Health Organization's trial with the same medications published in 1998. 27
Conversely, in a review of nine studies that included documentation of time from unprotected intercourse to initiation of therapy, Trussell and colleagues 20 found that delaying the onset of treatment to day 3 did not affect outcome, including a delay between 72 and 120 hours in some women. As a result, they and other authors recommended that emergency oral contraception therapy be considered even beyond day 3. 20 , 28 However, the American College of Obstetrics and Gynecology in their publication, Practice Patterns: Emergency Oral Contraception 1996, 29 thought that there were insufficient data to evaluate the effectiveness of initiating emergency contraception after 72 hours.
Nausea and vomiting, although less bothersome than with high-dose estrogen therapy, are still common side effects with this regimen. Nausea, which may occur after either dose and last for as long as 2 days, has been reported to occur in as many as 30% to 60% of women with emesis in up to 22%. 16 , 30 , 31 Taking the medication with food or meals often reduces the nausea. Because antiemetics do not appear to be as effective if they are taken after the onset of symptoms, 19 women are often encouraged to take them 1 hour before each dose. 32 , 33 Some physicians and clinics routinely prescribe antiemetics, thus eliminating the patient's need to recontact her provider. 29
Occasionally, patients are concerned that they may have vomited their contraceptive pills if they have an episode of emesis shortly after taking the medication. There are no published data associating early onset of emesis with an increased risk of failure; however, none of the studies were designed to evaluate this effect specifically. One may postulate that if the underlying cause of the nausea is from an estrogen-mediated effect on the central nervous system, sufficient absorption of the estrogen would have occurred by the time the patient began to experience these symptoms. 29 Some authors have encouraged patients to take an extra set of oral contraceptive pills should emesis occur within 2 to 3 hours of ingesting a dose. However, taking additional medication does not increase the efficacy of the therapy and may only worsen the centrally mediated nausea. Other less-common reported side effects include abdominal pain (2.1% of women treated), dizziness (2.1%), uterine cramping (1.4%), and, rarely, breast tenderness (1% to 4%), headache, and fluid retention. 16
The contraceptive effect of postcoital birth control pills is thought to be mediated through a number of different mechanisms, including the following: (1) changes in cervical mucus that reduce sperm penetration; (2) suppression of pituitary hormone secretion, which inhibits or delays ovulation; (3) disruption of luteal function by direct action on the corpus luteum; (4) alteration of tubal gamete transport; (5) suppression of endometrial estrogen and progesterone receptors when administered within 5 days of the luteinizing hormone (LH) surge; and (6) modification of endometrial development, which interferes with implantation of a potentially fertilized ovum. 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 Endometrial biopsies performed after postcoital oral contraception show a marked asynchrony in the maturation of the endometrial glands and stroma. This disordered, out-ofphase endometrium interferes with implantation. 14 The particular mechanism depends on the precise point within a menstrual cycle in which postcoital hormonal therapy is administered. If given before ovulation, follicular development and ovulation are altered; with postovulatory administration, the effect on the endometrium predominates.
Administration of postcoital oral contraceptives may affect the onset of the woman's next menstrual period. 19 , 40 , 41 , 42 Timing of the postmedication withdrawal bleed depends on the exact phase of the woman's cycle during which postcoital contraceptives are administered. If she takes the pills in the periovulatory period, the next menses usually begins a few days earlier than expected. If exposure occurs in the follicular phase, the cycle is aborted and the next menses may begin as early as day 21. Luteal phase administration may delay the onset of the menstrual bleed by a couple of days. The duration of the menstrual flow is normal in more than 90% of women. 30 The effect on menstrual cycle appears to be independent of the woman's history of regular or irregular cycles. 15 , 16 Because 98% of women menstruate by 21 days after treatment, it is important to advise the woman that she may be pregnant if her next menstrual period does not begin within that period. 15 , 16 , 25 , 33 She should be encouraged to obtain a pregnancy test and seek medical evaluation and counseling.
No published studies have reported evidenced-based criteria that would contraindicate the use of combination hormonal emergency contraception. 29 Although some studies have excluded women with absolute contraindications to oral contraceptives, there have been no reports of major cardiovascular or neurologic adverse events in any women. A history of thromboembolism is considered only a relative contraindication to hormonal postcoital contraception. A review of the records of 73,302 women who received emergency contraception in the United Kingdom between 1989 and 1996 identified 19 women in whom venous thromboembolism developed; however, none of them had been treated within 45 days of the diagnosis. 43 Although the daily dose of steroid hormones in emergency contraception is greater than that in normal oral contraceptive use, the duration is very short. It is thought that the risk of oral contraceptive hormones is based on long-term exposure and is not likely to pertain to emergency contraception. 19 , 25 , 44
In 1999 the FDA approved the first progestin-only emergency contraception pill, Plan B, manufactured by Women's Capital Corporation (Bellevue, WA). A prescription for Plan B provides two pills, each containing levonorgestrel 0.75 mg, with instructions to take one pill as soon as possible within 72 hours after unprotected coitus and the second pill 12 hours later.
Although this alternative emergency contraception regimen had been known to physicians in the United States, before the approval of Plan B, it was little used because of the lack of a convenient progestin-only pill. Two different regimens had been studied. The most popular one required administration of 0.75 mg levonorgestrel beginning no later than 8 hours after intercourse with a repeat dose 24 hours later. If another episode of unprotected intercourse occurred on a subsequent day, it was recommended that the two levonorgestrel doses be repeated until seven doses had been administered. 45 , 46 Some authors suggested that the initial levonorgestrel dose may be started as late as 48 hours after unprotected intercourse. 45 An alternate, less-studied regimen consisted of a single dose of 0.6 mg levonorgestrel administered within 12 hours of intercourse. 47 Before 1999 levonorgestrel-only tablets were not available in the United States. Instead, an equivalent dosage of the minipill, Ovrette, was prescribed. One Ovrette tablet contains 0.075 mg norgestrel, which is equivalent to 0.0375 mg levonorgestrel. Using the available medication, progestin-only emergency contraception in the United States required two doses, each consisting of 20 tablets of Ovrette for the first regimen (total of 40 pills) or 16 tablets of Ovrette for the second regimen (total of 32 pills). Development and approval of Plan B has dramatically changed our options for a progestin-only emergency contraception.
FDA approval was based on a large study, published in 1998 by the World Health Organization Task Force on Postovulatory Methods of Fertility Regulation, which showed the levonorgestrel regimen to be more effective and better tolerated than the Yuzpe method. 48 In 1955, evaluable women were randomly assigned to the two different regimens; the pregnancy rate in patients who received levonorgestrel was 1.1% versus 3.2% in the women treated with the Yuzpe method. The crude relative risk of pregnancy for levonorgestrel compared with the Yuzpe regimen was 0.36 (95% confidence interval [CI], 0.18, 0.70) and the proportion of pregnancies prevented compared to the expected number without treatment was 85% (95% CI, 74, 93%) with levonorgestrel and 57% (95% CI, 39, 71%) with the Yuzpe method. Nausea (23.1% versus 50.5%) and vomiting (5.6% versus 18.8%) were significantly less frequent with the levonorgestrel regimen than with the Yuzpe regimen ( p < .01), and the efficacy of both treatments declined with increasing time since unprotected coitus ( p = .01).
The efficacy of the Yuzpe method in the 1998 WHO study was not as good as that reported in previous studies. In their comparison of levonorgestrel and the Yuzpe method published in 1993, Ho and Kwan 46 reported a corrected failure rate of 2.6% with progestin-only therapy and 2.4% with the combined oral contraceptives, and as cited above, a pooled analysis of 24 studies using the Yuzpe method in 9588 women calculated the average failure rate was 1.84% (range, 0.0% to 7.44%). 10
Because no estrogen is administered in the progestin-only regimen for emergency contraception, gastrointestinal side effect
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