Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days

• Published in: Contraception (Stoneham) 2015-04, Vol.91 (4), p.269-273
• Main Authors: Gatter, Mary, Cleland, Kelly, Nucatola, Deborah L
• Format: Article
• Language: English
• Subjects: Abortifacient Agents, Nonsteroidal - therapeutic use; Abortifacient Agents, Steroidal - therapeutic use; Abortion, Induced - methods; Administration, Buccal; Adolescent; Adult; Buccal misoprostol; Cohort Studies; Drug Therapy, Combination; Efficacy; Evidence-Based Medicine; Evidence-based regimen; Female; First-trimester abortion; Gestational Age; Humans; Logistic Models; Medical abortion; Mifepristone; Mifepristone - therapeutic use; Misoprostol - therapeutic use; Obstetrics and Gynecology; Pregnancy; Pregnancy Trimester, First; Retrospective Studies; Treatment Outcome; Young Adult
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2015.01.005

Abstract Objective The aim of this study was to report on the safety and efficacy of an evidence-based medical abortion regimen utilizing 200 mg of mifepristone orally followed by home use of 800 mcg misoprostol buccally 24–48 h later through 63 days estimated gestational age. Study design We analyzed outcomes in women presenting for medical abortion between April 1, 2006, and May 31, 2011, using an evidence-based alternative to the United States Food and Drug Administration (FDA)-approved regimen. Cases were identified for this descriptive study from our electronic practice management (EPM) database, and our electronic database on adverse events was queried for information on efficacy and safety. The primary outcome was successful abortion. Logistic regression was used to identify predictors of successful abortion. Results Among the 13,373 women who completed follow-up, efficacy of the regimen was 97.7%. Efficacy was highest at 29 to 35 days (98.8%) and 36 to 42 days (98.8%) of gestation and lowest at 57 to 63 days (95.5%). The odds of needing aspiration for any reason were greatest at higher gestational ages. Rates of infection requiring hospitalization and rates of transfusion were 0.01 and 0.03%, respectively. Conclusions An evidence-based regimen of 200 mg of mifepristone orally followed by home use of 800 mcg of buccal misoprostol 24–48 h later is safe and effective through 63 days estimated gestational age. Further, the need for aspiration for any reason was low, and hospitalization was rare. Implications This study reinforces the safety and efficacy of the evidence-based regimen for medical abortion (200 mg mifepristone orally followed by home use of 800 mcg of misoprostol buccally 24–48 h later) through 63 days estimated gestational age, and contributes to the existing evidence against restrictions requiring use of the FDA-approved regimen.