title: Multicenter trial of a simplified mifepristone medical abortion regimen.
abstract: OBJECTIVE
  To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 mug oral misoprostol
  
  
  METHODS
  The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 mug misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study
  
  
  RESULTS
  Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory
  
  
  CONCLUSIONS
  A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 mug oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration.
  
  
  METHODS
  III.
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 1617, New York, NY 10010, USA.
authors.forename: Caitlin S
authors.initials: CS
authors.lastname: Shannon
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
authors.forename: Richard
authors.initials: R
authors.lastname: Hausknecht
authors.forename: Eric
authors.initials: E
authors.lastname: Schaff
authors.forename: Paul D
authors.initials: PD
authors.lastname: Blumenthal
authors.forename: Deborah
authors.initials: D
authors.lastname: Oyer
authors.forename: Heather
authors.initials: H
authors.lastname: Sankey
authors.forename: Jessica
authors.initials: J
authors.lastname: Wolff
authors.forename: Rachel
authors.initials: R
authors.lastname: Goldberg
mesh_terms: D000032:Abortion, Therapeutic / Q000379:methods*; D000284:Administration, Oral; D000328:Adult; D003131:Combined Modality Therapy; D004107:Dilatation and Curettage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D016015:Logistic Models; D008423:Maternal Age; D015735:Mifepristone / Q000627:therapeutic use*; D016595:Misoprostol / Q000627:therapeutic use*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D016595:Misoprostol; D015735:Mifepristone