A randomized trial of mifepristone (10 mg) and levonorgestrel for emergency contraception.

OBJECTIVE: To compare the efficacy, patient acceptability and adverse effects of low-dose mifepristone (10 mg) with the levonorgestrel regimen (2 doses of 750 microg given 12 hours apart) for emergency contraception. METHODS: This randomized controlled trial compared mifepristone (10 mg) to levonorgestrel (2 doses of 750 microg given 12 hours apart) in the context of emergency contraception within 120 hours of unprotected intercourse. The primary outcome measure was unintended pregnancy. Secondary outcomes included adverse effects experienced by women, acceptability of the method of emergency contraception used, and the timing of the first menstrual cycle after treatment. RESULTS: The total number of women recruited was 2,065. The crude pregnancy rates were 1.3% and 2.0% for mifepristone and levonorgestrel (P = .46), with 77% and 64% of expected pregnancies prevented, respectively. Women receiving mifepristone were more likely to have a delayed onset of the subsequent menstrual cycle after treatment (P < .001), whereas those having levonorgestrel were more likely to have an early onset of the subsequent menstrual cycle (P < .001). Acceptability levels were high for both methods, with 94% of women receiving mifepristone and 91% receiving levonorgestrel expressing satisfaction. There was no difference in adverse effects (nausea, vomiting, breast tenderness, abdominal pain, lethargy, headache, hot flushes, and dizziness) experienced by women in the 2 groups. CONCLUSION: This study suggests that a small dose of mifepristone is not less effective than levonorgestrel for emergency contraception. Both regimens were highly acceptable to women.

Mifepristone versus the Yuzpe regimen (PC4) for emergency contraception.

OBJECTIVE: To compare side effects, women's acceptance and satisfaction with mifepristone (100 mg) versus the Yuzpe regimen for emergency contraception (EC). METHODS: A total of 1000 women requesting EC within 72 h of unprotected intercourse were randomized to receive mifepristone 100 mg or the standard Yuzpe regimen. Outcome measures included patient acceptability and satisfaction. RESULTS: A total of 620 (62%) questionnaires were returned, 64% in the mifepristone group and 60% in the Yuzpe group. Mifepristone was better tolerated than the Yuzpe regimen. The rates of nausea (P<0.0001), abdominal pain (P=0.001), tiredness (P<0.0001), lethargy (P=0.001), hot flushes (P<0.0001) and dizziness (P<0.0001) were all significantly higher in women given the Yuzpe regimen compared to those who received mifepristone. Of these 94% and 80% in the mifepristone and Yuzpe groups, respectively, were satisfied with treatment (P<0.0001). Of women in the mifepristone group, 56% (181/321) had used the Yuzpe regimen of EC in the past and of these, 93.6% (161/172) indicated they would use mifepristone in the future. A total of four women in the Yuzpe group had mifepristone in the past and all four said they would use mifepristone in the future. CONCLUSION: Mifepristone has high patient acceptability and few side effects compared to the standard Yuzpe regimen for EC.

Analgesia requirements and predictors of analgesia use for women undergoing medical abortion up to 22 weeks of gestation.

OBJECTIVE: To assess analgesia use and the predictors for requiring analgesia in women undergoing medical abortion at all gestations up to 22 weeks. DESIGN: Retrospective observational study. SETTING: Aberdeen Royal Infirmary, Scotland. POPULATION: Consecutive women undergoing medical abortion under the terms of the 1967 Abortion Act. METHODS: Analgesia requirements and characteristics of women undergoing abortion were analysed using logistic regression. MAIN OUTCOME MEASURES: The effect of age, gestation, reproductive history, route and dose of misoprostol administration on analgesia requirements. RESULTS: Of the total 4343 women included in this review, 3139 women (72%) required analgesia. Of these, 3054 women (97%) used oral analgesia, 75 women (2.4%) used opiates while 10 women (0.3%) had diclofenac sodium given rectally. There was no significant difference in analgesia use whether women used the vaginal or sublingual route of misoprostol administration. Logistic regression showed a significant positive association with gestation at termination (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.05-1.12), number of misoprostol doses used (OR 1.31, 95% CI 1.13-1.51) and induction to abortion interval (OR 1.08, 95% CI 1.03-1.12) and a negative association with the age of women undergoing abortion (OR 0.98, 95% CI 0.97-0.99) and previous live birth (OR 0.43, 95% CI 0.33-0.56). CONCLUSIONS: Analgesia requirement was significantly higher in women of younger age, higher gestation, longer induction to abortion interval and with increased number of misoprostol doses used while women with previous live birth were significantly less likely to use analgesia.

Midtrimester medical termination of pregnancy: a review of 1002 consecutive cases.

We assessed the effectiveness, safety and factors that affected the outcome of midtrimester medical termination of pregnancy at 13-21 weeks gestation. Of the 1002 women, 3 took mifepristone and decided to continue with the pregnancy, with 999 women being compliant with the regimen. Of these, 2 women aborted prior to administration of misoprostol and 970 (97.1%) aborted successfully within five doses of misoprostol. Surgical intervention was necessary to complete the abortion process in 81 (8.1%) women. Women with no previous pregnancy (p = 0.02), no previous live birth (p = 0.0001) and gestations 17-21 weeks (p = 0.001) required more prostaglandin. Younger women (p = 0.0001) and women with a previous live birth (p = 0.001) were more likely to have a successful abortion. The induction abortion interval was significantly longer with increasing gestation [95% confidence interval (CI) difference in means: -2.52 to -0.89, p = 0.0001], increasing age (p = 0.0001) and no previous live birth (95% CI difference in means: -0.25 to -1.01, p = 0.0001). Surgical intervention was more likely to be required with increasing age (p = 0.008). Mifepristone in combination with misoprostol is a safe and effective regimen for midtrimester medical abortion with younger women and those with a previous live birth more likely to have a successful abortion.

A pilot study of mifepristone in combination with sublingual or vaginal misoprostol for medical termination of pregnancy up to 63 days gestation.

Of the total women included in the study, 96 women chose to receive misoprostol 600 microg sublingually while 53 women received misoprostol 800 microg vaginally 36-48 h after receiving mifepristone 200 mg. Complete abortion occurred in 93 women (98.9%) in the sublingual and 51 women (96.2%) in the vaginal group (p = 0.27). The mean induction-to-abortion interval was 3.2 h (SD = 1.4) in the sublingual and 4.1 h (SD = 1.5) in the vaginal group (p = 0.02). The mean gestation at abortion in weeks was 7.1 (SD = 1.0) in the sublingual and 7.7 (SD = 1.3) in the vaginal group (p = 0.003). Women in the sublingual group experienced more vomiting (p = 0.03), diarrhea (p = 0.02) and unpleasant taste in their mouth (p = 0.0001) while those in the vaginal group experienced more headache (p = 0.002). Of women in the sublingual group, 77% were satisfied with the route of misoprostol administration compared to 68% in the vaginal group (p = 0.25). These findings now need to be assessed in the context of a randomized controlled trial.