Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion - A randomized trial

Context The conventional timing of misoprostol administration after mifepri stone for medical abortion is 2 days, but more flexible intervals, which ma y make the regimen more convenient, have not been studied. Objective To determine whether vaginal misoprostol administered 1,2, or 3 d ays after mifepristone influences safety or effectiveness for abortion at L ip to 56 days' gestation. Design Prospective, randomized, open-label trial conducted from March 1998 to June 1999. Setting Sixteen US primary care and referral abortion facilities. Patients A total of 2295 healthy patients aged 18 years or older who were 5 6 or fewer days pregnant. Forty (1.7%) were lost to follow-up. Interventions Patients received 200 mg of oral mifepristone and were random ly assigned to self-administer 800 mu g of vaginal misoprostol at home 1 (n =745), 2 (n = 778), or 3 (n = 772) days later, Women returned to the clini c up to 8 days after mifepristone for ultrasonographic evaluation. A second dose of misoprostol was administered if the abortion was not complete. Pat ients with continuing pregnancy, excessive bleeding, or retained pregnancy tissue 5 weeks later received an aspiration curettage. Main Outcome Measures Effectiveness of the procedure (ie, a complete medica l abortion without surgical intervention), adverse effects, acceptability o f the procedure based on patient questionnaires, reasons for surgical inter vention, and adverse outcomes, compared among the study groups. Results Of the 2255 women completing follow-up, complete medical abortion r ates were 98% (95% confidence interval [CI], 97%-99%) among those using mis oprostol after 1 day, 98% (95% CI, 97%-99%) for those using misoprostol aft er 2 days, and 96% (95% CI, 95%-97%) among those using misoprostol after 3 days. Fifty-five subjects aborted before taking misoprostol, 9 had early su rgery, and 103 did not take misoprostol on their assigned day, No blood tra nsfusions were required. Cramping and nausea were the most common adverse e ffects reported, with similar percentages of patients in all 3 groups repor ting such effects. Thirteen unexpected or serious adverse events occurred: 6 in those using misoprostol after 1 day; 4 in those using it after 2 days; and 3 in those using it after 3 days. Nearly all women (>90%) found the pr ocedure to be acceptable. Conclusions Our results suggest that vaginal misoprostol, 800 mu g, can be used from 1 to 3 days after mifepristone, 200 mg, for early medical abortio n, and need not be administered strictly 48 hours after mifepristone.