Emergency contraception in Cuba with 10 mg of mifepristone.

BACKGROUND: Mifepristone in a dose of 10 mg is an effective emergency contraceptive when administered up to 120 hours after unprotected coitus. METHODS: Between May 2003 and February 2005, we conducted in Cuba a single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception up to 6 days after unprotected coitus. A total of 635 women who requested emergency contraception after a single act of unprotected intercourse were included in the study. RESULTS: After treatment there were 7/635 (1.1%) pregnancies (95% CI 0.4-2.3%). Pregnancy that might have occurred was prevented in 88.0% of the cases (95% CI 77.1-95.1%). The most common side effects reported by participants were fatigue (10.7%), dizziness (6.1%) and nausea (4.9%); vomiting was only reported by 0.6%. In 38/635 (6.0%) women menstruation was delayed more than 7 days. CONCLUSIONS: Mifepristone 10 mg administered is an effective emergency contraceptive with an acceptable profile of side effects up to five days, but greater studies are necessary to verify its efficacy up to 6 days after unprotected intercourse.

Misoprostol 3, 4, or 5 days after methotrexate for early abortion. A randomized trial.

A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at < or = 63 days' gestation. Subjects received 50 mg/m2 methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 micrograms of misoprostol 3, 4, or 5 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), and side effects. Eighty-six cases (93%; 95% confidence interval [CI] 85%-97%) aborted in Group I; 90 cases (92%; 95% CI 84%-96%) aborted in Group II (relative risk [RR] = 1.09; RR 95% CI 0.38-3.14); and 89 (93%; 95% CI 86%-97%) cases aborted in Group III (RR = 0.97; RR 95% CI 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 (92%; 95% CI 89%-95%) patients. Twenty-two cases (8%; 95% CI 5%-11%) resulted in failure. Side effects for methotrexate were minimal while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.

PIP: A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at 63 days or less gestation. Subjects received 50 mg/sq. m methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 mcg of misoprostol 3, 4, or 5 days after methotrexate administration. The misoprostol dose was repeated 48 and 96 hours later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. 86 cases [93%; 95% confidence interval (CI), 85-97%] aborted in Group I; 90 cases (92%; 95% CI, 84-96%) aborted in Group II [relative risk (RR) = 1.09; RR 95% CI, 0.38-3.14]; and 89 cases (93%; 95% CI, 86-97%) aborted in Group III (RR = 0.97; RR 95% CI, 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after methotrexate administration (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 patients (92%; 95% CI, 89-95%). 22 cases (8%; 95% CI, 5-11%) resulted in failure. Side effects for methotrexate were minimal, while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.