Side effects of the Yuzpe regimen of emergency contraception and two modifications

We investigated side effects after the standard Yuzpe regimen or two modifications: substituting norethindrone as the progestin or eliminating the second dose. We also examined the impact of taking either dose with food. Nearly two thirds of women reported at least one side effect, the majority of which were mild or moderate. Women in our study experienced more side effects after the second dose than after the first. Taking the first dose within 1 h of a meal or snack was associated with increased nausea and vomiting; taking the second dose within 1 h of a meal or snack was associated with decreased nausea and vomiting. A targeted approach to prophylactic antiemetic use could reduce the number of women given these drugs, and the number who experience unnecessary side effects. The impact of counseling on side effects should be further evaluated.     

Comprehension of a prototype emergency contraception package label by female adolescents

Background

We evaluated female adolescents' comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product.

Study Design

Volunteers aged 12-17 years who could read English were recruited at malls and clinics in six United States metropolitan areas. After completing a literacy assessment, subjects examined the prototype package and answered 20 questions that assessed understanding of six key concepts related to appropriate use of the product.

Results

The analysis population included 335 subjects, 54 to 59 of each year of age between 12 and 17 years. When asked what the product is used for, 264 respondents (79%) specifically indicated contraception. The six key concepts were each understood by 83-96% of subjects. In all 24 population subgroups examined, each key concept was understood by at least 72% of subjects.

Conclusion

Female adolescents aged 17 years and younger understand the prototype package label well enough to enable safe and effective use without assistance from a clinician.     

Effectiveness of the Yuzpe regimen of emergency contraception by cycle day of intercourse: implications for mechanism of action

OBJECTIVE: The purpose of this study was to provide evidence about the mechanism of action of the Yuzpe method of emergency contraception by examining effectiveness by cycle day of intercourse relative to ovulation. METHODS: Through a literature search, we identified eight studies that present the number of women treated and outcome of treatment by cycle day of unprotected intercourse relative to expected day of ovulation. Using five sets of external estimates of conception probabilities by cycle day of intercourse among women not using contraception, we assessed and compared the effectiveness of the Yuzpe regimen by whether intercourse occurred on or before the second day before ovulation or afterward, and whether intercourse occurred on or before the first day before ovulation or afterward. RESULTS: In 36 of the 45 pairs of estimates of effectiveness, based on eight separate studies and the eight studies combined and five different sets of conception probabilities by cycle day, effectiveness was higher-and in most cases substantially higher-when intercourse occurred on or before the second day before ovulation (day -2) than when it occurred later. When data were stratified by whether intercourse occurred on or before the day before ovulation (day -1), effectiveness was greater when intercourse occurred early in 43 of 45 pairs. CONCLUSIONS: These results suggest that one hypothesized mechanism of action of the Yuzpe method, inhibiting implantation of a fertilized egg, is unlikely to be the primary mechanism of action.     

Minimum effectiveness of the levonorgestrel regimen of emergency contraception

The standard method for estimating the effectiveness of emergency contraceptive pills (ECPs) uses external data to calculate the proportion of expected pregnancies averted by the treatment. Because these data may not be applicable to ECP study populations, this approach could result in substantial overestimation of effectiveness. We used data from two published randomized trials of the levonorgestrel and Yuzpe ECP regimens to calculate the minimum effectiveness of the levonorgestrel regimen. Conservatively assuming that the Yuzpe regimen was entirely ineffective in these trials, we estimate that the levonorgestrel regimen prevented at least 49% of expected pregnancies (95% confidence interval: 17%, 69%). Because physiologic data suggests that the Yuzpe regimen does, in fact, have some efficacy, the effectiveness of the levonorgestrel regimen is likely to be higher than our minimum estimate.     

Over-the-counter access to emergency contraception for teens

This synopsis of teens and OTC access is part of a series of briefs on emergency contraception, which address the following issues as they relate to EC: Is emergency contraception safe? Is emergency contraception effective at preventing pregnancy? Does emergency contraception promote sexual risk-taking? Is emergency contraception cost-effective? Does emergency contraception cause abortion? The full series can be found at http://crhrp.ucsf.edu.     

As often as needed: appropriate use of emergency contraceptive pills

Previous research has established that emergency contraceptive pills are safe and have the potential to reduce unintended pregnancy; however, policy makers, providers and even women themselves have expressed concern about repeat use of the method. Evidence regarding the safety, efficacy and frequency of repeat use show that the method is safe and effective, even when used multiple times. Reported rates of repeat use are actually lower than would be expected, and needed, based on the frequency of unprotected intercourse and contraceptive failure reported in most countries. Healthcare providers should encourage use of emergency contraceptive pills as a backup after recognizable failure of barrier methods or other hormonal contraceptive methods, and should expect that women may need emergency contraceptive pills multiple times during their reproductive years.     

Combined estimates of effectiveness of mifepristone 10 mg in emergency contraception

The present paper combines the estimates of efficacy and side effects of 10 mg mifepristone for emergency contraception obtained from randomized trials. A total of 6083 women participating in 12 randomized trials and receiving 10 mg mifepristone for emergency contraception up to 120 h after intercourse, were analyzed for efficacy. Between 4188 and 5833 women were analyzed for side effects and 3601 for delay of menses of more than 7 days. Prevented fractions, the effect of delay and of further acts of intercourse after treatment administration were analyzed in 3440 women, using individual data. The combined pregnancy rate from all the 12 trials was 1.7% [101/6083, 95% confidence interval (CI): 1.3–2.2]. From the three trials providing individual data, the combined pregnancy rate was 1.3% (45/3440, 95% CI: 0.9–1.7) and the estimate of pregnancies prevented was 83.4% (95% CI: 77.4–87.8). There was a sharp decline in efficacy when treatment was administered during the 5th day after intercourse compared to administration during the 1st day, the odds of pregnancy increasing by a factor of 5.3 (95% CI: 1.9–14.9). The relative risk of pregnancy was about 28 times higher among women with unprotected acts of coitus between treatment administration and the onset of next menses, compared with women reporting none [odds ratio (OR) = 27.6, 95% CI: 12.7–60.2]. The increase in risk for women reporting protected acts of intercourse during this interval was not statistically significant (OR = 1.8, 95% CI: 0.9–3.8). There was a large heterogeneity among trials in all side effects and delay of menses of more than 7 days (all had p < 0.0001 for the test of homogeneity). The percentage of women with nausea ranged from 0.0–19.4% (highest upper 95% confidence limit: 23.0%), that of vomiting from 0.0–4.3% (highest upper 95% confidence limit: 6.1%), that of lower abdominal pain from 4.3–19.1% (highest upper 95% confidence limit: 22.7%). The percentage of women with delay of menses of more than 7 days ranged from 4.3–25.8% (highest upper 95% confidence limit: 34.1%). We conclude that 10 mg mifepristone is an effective emergency contraception regimen, with an acceptable side-effects profile. Postponing treatment until the 5th day seriously decreases efficacy. The risk of pregnancy is dramatically increased among women having unprotected acts of intercourse between treatment administration and the onset of next menses. This risk may be enhanced for women whose ovulation is postponed by treatment.     

Estimating the effectiveness of emergency contraceptive pills

OBJECTIVE: We use new estimates of conception probabilities by cycle day of intercourse, where cycle day is measured with day 1 being the first day of bleeding in a cycle, to propose a new approach for estimating the effectiveness of emergency contraceptive pills (ECPs). We use this new approach to examine the absolute effectiveness and the cost-effectiveness of ECPs and whether ECPs are more effective the sooner after unprotected intercourse they are initiated. METHODS: Using the new set of conception probabilities, we employ data from two recent clinical trials of ECPs, one from the Population Council and the other from the World Health Organization (WHO), to examine the effectiveness of the combined ECP regimen. RESULTS: The expected pregnancy rate among typical users was 6.2% in the Population Council trial and 7.4% in the WHO trial based on conception probabilities by cycle day relative to the day of ovulation. Based on conception probabilities by cycle day relative to the first day of bleeding, the expected pregnancy rates dropped to 5.4% and 5.2%, respectively. The two trials yield conflicting evidence regarding whether effectiveness declines with treatment delay. CONCLUSIONS: Our results suggest that the absolute levels of effectiveness for the Yuzpe regimen of emergency contraception and the cost-effectiveness of this regimen have probably been overstated when based on conception probabilities by cycle day relative to day of ovulation.     

Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians

Emergency contraception was introduced in Nigeria over two decades ago, but few women have used this method even in emergency situations because of the side effects. To find an acceptable levonorgestrel regimen for emergency contraception in our community, the two-dose regimen 0.75-mg levonorgestrel 12 h apart (group A) and the single dose 1.5-mg levonorgestrel (group B) were studied in 1118 volunteers. Mild side effects such as nausea, vomiting, lower abdominal pains, menorrhagia, dizziness, headache, and breast tenderness were reported. Significantly more women in the high-dose group reported headache, breast tenderness, and heavy menstrual flow. Eleven pregnancies (1.0%) were reported (7 in group A and 4 in group B). The crude relative risk of pregnancies was similar in the two groups (RR = 0.71, 95% CI = 0.32-1.55; p > 0.05) [corrected]. On the other hand, the estimated effectiveness rate of 86.80% in group A was significantly lower than the 92.99% for group B (p < 0.05). The pregnancy rates increased with delay in starting treatment and if further acts of unprotected sexual intercourse took place after treatment. It was concluded that both regimens were effective and safe.     

Ongoing contraception after use of emergency contraception from a specialist contraceptive service

Background

A consultation for emergency contraception (EC) gives way to an opportunity to provide women with an ongoing effective method of contraception.

Study Design

A review of the case notes of women seeking EC from a large family planning clinic in Edinburgh, Scotland, was conducted to determine what percentage of women were provided with an effective method of ongoing contraception.

Results

Case notes of 460 women presenting for EC over a 2-year period were reviewed. Women were of mean age 26 years (range 15–49 years) and presented because they had used no contraception (47%), experienced condom failure (42%) or missed oral contraceptive pills (9%). Only 2% (n=11) were given an intrauterine device for EC. All women who had missed contraceptive pills prior to taking EC opted to continue this method. Only 23% (n=89) of women using no method or condoms at EC received supplies of an effective contraceptive method (pills, patch, injectable). Two thirds (n=263) of the women chose condoms for ongoing contraception.

Conclusion

Research is required to develop strategies to improve the uptake of effective contraception after EC.     

Ectopic pregnancy after levonorgestrel emergency contraception

Background

Although the possibility of ectopic pregnancy after intake of levonorgestrel (LNG) as an emergency contraceptive (EE) pill is well-known, the causality has not been well established.

Case

A 27-year-old nulliparous woman with regular menstrual periods took 1.5-mg LNG EE midcyclic 5 h after an unprotected intercourse. She had prolonged vaginal bleeding at the expected time. She consulted the general practitioner because of continuous vaginal bleeding for 4 weeks and lower abdominal pain. The pregnancy test was positive, and her symptoms and clinical findings suggested an ectopic pregnancy. At emergency surgery, she was found to have a left tubal pregnancy.

Conclusion

The possible role of 1.5-mg LNG EE in causing ectopic pregnancy is discussed. A high serum LNG concentration decreases ciliary activity and tube motility, but further epidemiological studies are necessary to establish the risk of ectopic pregnancy following intake of LNG EE.     

Need for emergency contraception in urgent care settings

BACKGROUND: Emergency contraceptive (EC) pills are safe and effective in preventing pregnancy up to 5 days after unprotected sex. OBJECTIVE: This study was conducted to determine the proportion and characteristics of women seeking urgent care who might benefit from receiving EC. METHODS: We used a computerized survey to assess desire for pregnancy and frequency of sex without contraception among 360 fertile women aged 18 to 45 years, who were seeking urgent care at two clinics in San Francisco, CA. Medical records were abstracted to assess whether clinicians discussed contraception. RESULTS: At both clinics, 11% (95% confidence interval, 8-15%) of women seeking urgent care might have benefited from immediately using EC. Few (8%) women reported a personal objection to EC, but few (7%) women had used EC in the prior 6 months. Chart review showed no evidence that any participants discussed EC with a clinician during their visit. CONCLUSIONS: Many women presenting for urgent care might benefit from EC.     

Ectopic pregnancies following emergency levonorgestrel contraception

There are little or no data on the risk of ectopic pregnancy following levonorgestrel treatment as an emergency contraception. We encountered three cases of ectopic pregnancy following the use of levonorgestrel administered peri- or postovulation. Here we report these cases and discuss the clinical and epidemiologic implications of this association. Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking levonorgestrel.     

Evaluation of an emergency contraception advance provision service

Timely access to emergency contraception (EC) could increase use when needed, and potentially lead to improved efficacy. We evaluated an advance provision service in the UK. Women were supportive of the service. They indicated that having EC on hand would not change their regular contraceptive use, and supported wider dissemination of information on the service, particularly to younger women. Although some women were supportive of further deregulation of EC, many cited fear of "abuse" or health risks of EC as reasons for strict control. We conclude that advance provision services increase access to EC and are particularly important where EC is not yet available from pharmacists. Providers and women need accurate information on the safety of EC. Uptake of advance provision services could be improved by providing subsidized or free EC to those who cannot pay, and by targeting information to younger women.     

Routine counseling about intrauterine contraception for women seeking emergency contraception

Objective

To compare contraceptive knowledge and use among women seeking emergency contraception (EC) before and after an inner-city clinic began providing structured counseling and offering same-day intrauterine device (IUD) or implant placement to all women seeking EC.

Study design

For 8 months before and 21 months after this change in clinic policy, women aged 15–45 who wanted to avoid pregnancy for at least 6 months were asked to complete surveys immediately, 3 and 12 months after their clinic visit. In addition, we abstracted electronic medical record (EMR) data on all women who sought EC (n= 328) during this period. We used chi-squared tests to assess pre/post differences in survey and EMR data.

Results

Surveys were completed by 186 women. After the clinic began offering structured counseling, more women had accurate knowledge of the effectiveness of IUDs, immediately and 3 months after their clinic visit. In addition, more women initiated IUD or implant use (survey: 40% vs. 17% preintervention, p=0.04; EMR: 22% vs. 10% preintervention, p=0.01), and fewer had no contraceptive use (survey: 3% vs. 17% preintervention, p<0.01; EMR: 32% vs. 68%, p<0.01) in the 3 months after seeking EC. EMR data indicate that when same-day placement was offered, 11.0% of women received a same-day IUD. Of those who received a same-day IUD, 88% (23/26) reported IUD use at 3-months and 80% (12/15) at 12 months.

Conclusions

Routine provision of structured counseling with the offer of same-day IUD placement increases knowledge and use of IUDs 3 months after women seek EC.

Implications

Women seeking EC from family planning clinics should be offered counseling about highly effective reversible contraceptives with the option of same-day contraceptive placement.