title: Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial.
abstract: OBJECTIVE
  To estimate the clinical benefit of pretreatment with mifepristone followed by misoprostol compared with misoprostol alone for second-trimester abortion.
  
  
  METHODS
  Two hundred sixty women with live fetuses of gestational ages 14-21 weeks were enrolled in a randomized, placebo-controlled, double-blind trial in Vietnam. Eligible consenting women received either mifepristone or placebo to take on their own at home and were scheduled to return to the hospital the next day. At the hospital, women were given 400 micrograms buccal misoprostol every 3 hours, up to five doses, until both the fetus and placenta were expelled. Efficacy was evaluated 15 hours after misoprostol dosing began and the procedure was considered complete if uterine evacuation was achieved without recourse to surgical evacuation.
  
  
  RESULTS
  Pretreatment with mifepristone resulted in more than twice the chance of complete uterine evacuation in 15 hours (79.8% compared with 36.9%, relative risk 2.16, 95% confidence interval 1.70-2.75). The mean induction-to-abortion interval for complete uterine evacuations was statistically significantly shorter among participants pretreated with mifepristone compared with those given misoprostol alone (8.1, standard deviation 2.8, range 2.5-14.8; and 10.6, standard deviation 2.5, range 6.5-15.5 hours, respectively; P<.001). The side-effect profiles for the two regimens did not differ significantly and acceptability of the treatments was high.
  
  
  CONCLUSIONS
  Mifepristone-misoprostol is more efficacious and faster than misoprostol alone. Services offering home administration of mifepristone as pretreatment could optimize efficacy and acceptability of medical abortions for women with gestations 14-21 weeks since the last menstrual period.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00784186.
  
  
  METHODS
  I.
authors.affiliation: From the Center for Research and Consultancy in Reproductive Health and Hung Vuong Hospital, Ho Chi Minh City, Vietnam; Gynuity Health Projects, New York, New York; and the Vietnam National Ob-Gyn Hospital, Hanoi, Vietnam.
authors.forename: Nguyen Thi Nhu
authors.initials: NTN
authors.lastname: Ngoc
authors.forename: Tara
authors.initials: T
authors.lastname: Shochet
authors.forename: Sheila
authors.initials: S
authors.lastname: Raghavan
authors.forename: Jennifer
authors.initials: J
authors.lastname: Blum
authors.forename: Nguyen Thi Bach
authors.initials: NTB
authors.lastname: Nga
authors.forename: Nguyen Thi Hong
authors.initials: NTH
authors.lastname: Minh
authors.forename: Van Quy
authors.initials: VQ
authors.lastname: Phan
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000627:therapeutic use*; D000021:Abortifacient Agents, Steroidal / Q000627:therapeutic use*; D000028:Abortion, Induced / Q000379:methods*; D000278:Administration, Buccal; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage / Q000627:therapeutic use*; D016595:Misoprostol / Q000627:therapeutic use*; D010147:Pain Measurement; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone