title: Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period.
abstract: OBJECTIVE
  Mifepristone-misoprostol medical abortion has been approved in the United States since 2000. U.S. providers have preferred to use vaginal misoprostol because of evidence that such a regimen is more effective in later gestations. Buccal administration of misoprostol may be equally effective and more acceptable to some women.
  
  
  METHODS
  This open-label, randomized trial was conducted at two sites in Rochester, NY, and involved healthy women with pregnancies through 56 days since the last menstrual period (LMP) as indicated by sonogram. Women received mifepristone 200 mg orally and were randomized to use 800 mug of misoprostol either buccally or vaginally 1 to 2 days later. They returned within 15 days for repeat sonogram. If the woman's pregnancy had not been completely aborted by day 36, a suction abortion was performed. The primary outcome was a complete abortion without surgical intervention.
  
  
  RESULTS
  Four hundred forty-two women were enrolled in the study, and complete data were available on 429. The efficacy rate was 95% (205/216) in the buccal group and 93% (199/213) in the vaginal group (chi(2)=0.43, p=.51). Nausea was the most commonly reported side effect, affecting 70% in the buccal group and 62% in the vaginal group. There were no differences in the satisfaction with the overall procedure between the buccal (92%) and the vaginal groups (95%) (chi(2)=1.87, p=.17).
  
  
  CONCLUSIONS
  Buccal administration of misoprostol after low-dose mifepristone for medical abortion appears to be a highly effective and acceptable alternative compared with vaginal administration for medical abortion in pregnancies through 56 days LMP.
authors.affiliation: Department of Family Medicine, University of Rochester School of Medicine, Rochester, NY 14620, USA.
authors.forename: Tamer
authors.initials: T
authors.lastname: Middleton
authors.forename: Eric
authors.initials: E
authors.lastname: Schaff
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Fielding
authors.forename: Mary
authors.initials: M
authors.lastname: Scahill
authors.forename: Caitlin
authors.initials: C
authors.lastname: Shannon
authors.forename: Emily
authors.initials: E
authors.lastname: Westheimer
authors.forename: Tracey
authors.initials: T
authors.lastname: Wilkinson
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage*; D000028:Abortion, Induced; D000278:Administration, Buccal; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D016009:Chi-Square Distribution; D005260:Female; D005865:Gestational Age; D006801:Humans; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone