Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.

OBJECTIVE: To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP). METHODS: This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24-36 hours after mifepristone 200 mg with 7-14-day follow-up. RESULTS: Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92-0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24-11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57-63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82-0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0-20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods. CONCLUSION: Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867 LEVEL OF EVIDENCE: I.

Extending outpatient medical abortion services through 70 days of gestational age.

OBJECTIVE: To estimate the efficacy and acceptability of medical abortion at 64-70 days from last menstrual period (LMP) and to compare it with the already proven 57-63 days from LMP gestational age range. METHODS: This prospective, comparative, open-label trial enrolled 729 women with pregnancies 57-70 days from LMP requesting abortion at six U.S. clinics. Medical abortions were managed with 200 mg mifepristone and 800 micrograms buccal misoprostol and sites' service delivery protocols. Follow-up visits occurred 7-14 days after mifepristone, with an abortion considered complete if surgical intervention was not performed. Success, ongoing pregnancy, and acceptability rates were compared. RESULTS: A total of 629 cases were analyzable for efficacy. Success rates were similar in the two groups (57-63 days group: 93.5%, 95% confidence interval [CI] 90-96; 64-70 days group: 92.8%, 95% CI 89-95). Ongoing pregnancy rates also did not differ significantly (57-63 days: 3.1%, 95% CI 1.6-5.8; 64-70 days: 3.0%, 95% CI 1.5-5.7). Acceptability was high and similar in both arms, with most women (57-63 days: 87.4%; 64-70 days: 88.3%) reporting that their experience was either very satisfactory or satisfactory. CONCLUSION: Medical abortion with mifepristone and misoprostol in current outpatient settings is an efficacious and acceptable method of ending pregnancies 64-70 days from LMP and can be offered without alteration of existing services. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, www.clinicaltrials.gov, NCT00997347. LEVEL OF EVIDENCE: II.

Medical abortion: outcomes in a family medicine setting.

PURPOSE: To compare outcomes of early medical abortion with mifepristone and misoprostol in a family medicine setting and specialized reproductive health clinics. METHODS: This study used data collected from a prospective, open-label, randomized trial of oral versus buccal misoprostol efficacy. A secondary analysis was performed, evaluating efficacy, acceptability, and interventions after medication at the family medicine site compared with the 6 specialized reproductive health sites. RESULTS: Comparing data from patients in the family medicine setting (n = 116) to specialized reproductive health sites (n = 731) revealed no difference in overall efficacy (95.7% vs 93.4%; P = .351). The family medicine site used a second dose of misoprostol more frequently than the other sites (6.9% vs 2.5%; P = .018). In addition, uterine aspiration after medical abortion at the family medicine site was not used for "medically necessary" reasons whereas reproductive health clinics used it 2.6% of the time (marginally significant; P = .094). Patient satisfaction at family medicine sites was comparable to the other sites (91.2% vs 92.0%; P = .792). CONCLUSION: Medical abortion has similar efficacy and patient satisfaction when offered in a family medicine practice or at a reproductive health specialty clinic. These findings should reassure family physicians that medical abortion can be offered safely in their practices.