A repeat dose of misoprostol 800 mcg following mifepristone for outpatient medical abortion at 64-70 and 71-77 days of gestation: A retrospective chart review.

OBJECTIVE: To compare the effectiveness of outpatient medical abortion with mifepristone 200 mg and two misoprostol 800 mcg doses at 64-70 and 71-77 days of gestation. STUDY DESIGN: We conducted a retrospective chart review of medical abortion outcomes among clients with 64-77 day gestations at a Mexico City public clinic between February 2014 and November 2016 who took mifepristone 200 mg followed 24-48 h later by two doses of misoprostol 800 mcg four hours apart (first dose buccally, second dose sublingually). The primary outcome was successful medical abortion, defined as pregnancy expulsion without surgical intervention. We also assessed additional management and visits to other facilities. We compared outcomes by gestational age (64-70 vs 71-77 days). RESULTS: Of 602 charts reviewed, we analyzed 232 and 218 in the respective groups for effectiveness; nearly 25% of clients were lost to follow up. Treatment success occurred in 231 (99.6%, 95% CI 97.6-100%) clients at 64-70 days and 213 (97.7%, 95% CI 94.7-99.3%) clients at 71-77 days (p = 0.11). Ongoing pregnancy occurred in 1 (0.4%, 95% CI 0-2.4%) and 3 (1.4%, 95% CI 0.3-4.0%) clients, respectively (p = 0.36). Two charts from the 71-77 days group documented visits to other facilities: one bleeding concern prior to scheduled follow up and a hemorrhage during an aspiration intervention. CONCLUSIONS: Regimen effectiveness was high at 64-70 and 71-77 days among clients who attended follow up. However, with 25% attrition, it is difficult to draw definitive conclusions about effectiveness and associated safety. IMPLICATIONS: Mifepristone 200 mg followed by two doses of misoprostol 800 mcg four hours apart is a promising medical abortion regimen to improve efficacy in pregnancies from 64-77 days of gestation as compared to regimens with an initial single misoprostol dose. Prospective research is recommended to achieve more robust efficacy estimates.

A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.

OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.