Treatment of uterine myoma with 5 or 10mg mifepristone daily during 6 months, post-treatment evolution over 12 months: double-blind randomised clinical trial.

OBJECTIVES: To evaluate the efficacy and safety of 5 and 10mg doses of mifepristone for 6 months for the treatment of uterine fibroids and to check those results at 1 year post-treatment. STUDY DESIGN: Randomised double-blind clinical study carried out at the "Eusebio Hernández" Hospital, Havana, Cuba. One hundred and seventy-six women with symptomatic uterine fibroids received one daily capsule of 10mg mifepristone orally or one daily capsule of 5mg mifepristone orally, over 6 months. Up to two endometrial biopsies were performed. Reduction in fibroid volume was used to evaluate efficacy. RESULTS: The 5 and 10mg dose had a similar efficacy in reducing the fibroid volume, 48.1% and 39.1%, p=0.07, and that of the uterus, 30.3% and 27.2%, p=0.63, respectively. Twelve months after treatment the majority of the subjects were asymptomatic with symptom prevalence similar to that at the end of treatment, except for hypermenorrhea and metrorrhagia, although the intensity of hypermenorrhea was much less, p<0.01. CONCLUSIONS: (1) Both doses obtain similar results in reducing fibroid size. (2) Administering 6 months' treatment achieves symptomatic improvement lasting 1 year in a high percentage of cases. (3) More studies need to be carried out with longer treatment and follow-up periods.

Late second-trimester abortions induced with mifepristone, misoprostol and oxytocin: a report of 428 consecutive cases.

BACKGROUND: The aim of the study was to assess efficacy and safety of administering 200 mg of mifepristone between 36 and 48 h before the insertion of 800 mcg of vaginal misoprostol to induce late second-trimester abortion between 19.1 and 25.6 weeks gestation. STUDY DESIGN: A consecutive series of 428 women who requested a termination of their pregnancy between 19.1 and 25.6 weeks of gestation were analyzed. METHODS: Each woman received 200 mg of mifepristone orally between 36 and 48 h before the vaginal administration of 800 mcg of misoprostol and the insertion of two Dilapan intracervical tents if the gynecologist deemed necessary. Four hours after misoprostol, amniorrhexis was performed and intravenous oxytocin infusion started. The variables for assessing efficacy were the number of complete abortion without dilation and evacuation (D&E) and the time elapsed since misoprostol administration until the abortion. RESULTS: Complete abortion without surgery occurred in 387/428 (90.4%) subjects, and the mean time for misoprostol to abortion was 6.9+/-3.1 (SD) h. In 32/428 (7.5%) patients, it was necessary to administer a second 600-mcg misoprostol dose. The mean total oxytocin used was 9.7+/-7.9 (SD) IU. In 41/428 (9.6%) women, the abortion process was completed by D&E. A uterine rupture occurred in one woman with a previous cesarean section. CONCLUSION: The method of abortion that combined mifepristone, misoprostol and oxytocin was effective for interrupting pregnancies between 19.1 and 25.6 weeks of gestation. It is advisable to be well trained in D&E technique in case of possible failures and/or abortion inductions that are excessively prolonged.

Vaginal vs. sublingual misoprostol with mifepristone for cervical priming in second-trimester abortion by dilation and evacuation: a randomized clinical trial.

OBJECTIVES: The study was conducted to assess the effectiveness of mifepristone 200 mg 48 h before administering misoprostol 600 mug, sublingual vs. vaginal route, prior to dilation and evacuation (D&E) in 12- to 20-week pregnancies. DESIGN: Randomized clinical trial. SETTING: Clínica Mediterrania Médica, Valencia, Spain. SUBJECTS: Women with 12- to 20-week pregnancies wanting a voluntary abortion between July 9, 2004, and February 9, 2006. METHODS: Nine hundred women were randomized to be included in one of the following four groups: (I) mifepristone 200 mg plus sublingual misoprostol 600 microg before D&E, (II) mifepristone 200 mg plus vaginal misoprostol 600 microg before D&E, (III) sublingual misoprostol 600 microg before D&E and (IV) vaginal misoprostol 600 microg before D&E. MAIN OUTCOMES MEASURED: The degree of cervical dilation achieved before D&E, surgical time necessary to terminate the pregnancy and side effects of misoprostol. RESULTS: The average cervical dilation in the mifepristone groups was 12.5+/-2.8 mm (SD) [95% confidence interval (CI), 12.3-12.8] vs. 8.5+/-3.2 mm (SD) (95% CI, 8.2-8.8) in those receiving only misoprostol. Surgical time in the mifepristone sublingual misoprostol group was 11.9+/-4.3 min (SD) vs. 13.0+/-5.3 min (SD) in the sublingual misoprostol group without mifepristone (p=.007); in the mifepristone vaginal misoprostol group, the average surgical time was 12.3+/-5.0 min (SD) vs. 13.0+/-6.2 (SD) in the vaginal misoprostol group without mifepristone (p=.031). CONCLUSIONS: Administering mifepristone before D&E with misoprostol in second-trimester abortions makes surgery easier and shorter and, to a certain extent, lessens the risk of cervical injuries, especially in D&E in advanced gestational periods.