Feasibility and effectiveness of unintended pregnancy prevention with low-dose mifepristone combined with misoprostol before expected menstruation

• Published in: Human reproduction (Oxford) 2015-12, Vol.30 (12), p.2794-2801
• Main Authors: Li, Cui-Lan, Chen, Dun-Jin, Deng, Yi-Fan, Song, Li-Ping, Mo, Xue-Tang, Liu, Kai-Jie
• Format: Article
• Language: English
• Subjects: Abortifacient Agents - administration & dosage; Abortifacient Agents - therapeutic use; Adolescent; Adult; Chorionic Gonadotropin - blood; Contraceptive Agents - administration & dosage; Contraceptive Agents - therapeutic use; Drug Therapy, Combination; Female; Humans; Menstrual Cycle - drug effects; Menstruation - drug effects; Middle Aged; Mifepristone - administration & dosage; Mifepristone - therapeutic use; Misoprostol - administration & dosage; Misoprostol - therapeutic use; Pregnancy; Treatment Outcome; Young Adult
• ISSN: 0268-1161; 1460-2350
• DOI: 10.1093/humrep/dev239

STUDY QUESTION What is the efficacy of maintaining or restoring non-pregnant status with low-dose mifepristone combined with misoprostol administered before expected menstruation? SUMMARY ANSWER Low-dose mifepristone and misoprostol administered at the time of expected menstruation was effective and safe in maintaining or restoring non-pregnant status, with no obvious menstrual disturbance. WHAT IS KNOWN ALREADY Menstrual regulation involves the medical or mechanical stimulation of uterine sloughing in women with up to 2–3 weeks of menstrual delay. Low-dose mifepristone plus misoprostol is efficacious for termination of ultra-early pregnancy (≤35 days of amenorrhoea) with no obvious menstrual disturbance. STUDY DESIGN, SIZE, DURATION A total of 678 women fulfilled all criteria and were recruited. Seventeen women dropped out after deciding to remain pregnant and 11 others were lost to follow-up. Thus, data from 650 women who completed the procedure were included in analyses. Participants were enrolled at any time during their menstrual cycle and administered medication 1 day before expected menstruation. The end of the study was defined on a per-patient basis as the date of completion of the post-treatment menstrual cycle. The primary outcome was the efficacy of abortion induction (for pregnant women) or menstrual regulation (for non-pregnant women). PARTICIPANTS, SETTING, METHODS Women with regular menstrual cycles (25–35 days) were voluntarily recruited for this study between February 2012 and December 2014. Serum β-hCG was measured before mifepristone intake. Mifepristone (50 mg) was administered orally 1 day before expected menstruation and 200 µg misoprostol was administered orally on the day of expected menstruation. Efficacy, disturbance in bleeding patterns in the treatment and post-treatment cycles, satisfaction with the treatment, and subsequent contraception preference were analysed. MAIN RESULTS AND THE ROLE OF CHANCE Retrospective analysis of serum β-hCG levels at admission indicated that 23.3% (158/678) of the women were pregnant. The success rate for pregnancy termination was 98.6% (136/138). Two women (1.5%, 2/138) had ongoing pregnancy that was subsequently terminated surgically. The overall bleeding induction rate within 7 days was 98.3% (639/650), with 100% (138/138) in pregnant participants and 97.9% (501/512) in non-pregnant participants. Most pregnant and non-pregnant participants experienced no significant menstrual disturbance during