title: Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.
abstract: OBJECTIVE
  To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP).
  
  
  METHODS
  This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24-36 hours after mifepristone 200 mg with 7-14-day follow-up.
  
  
  RESULTS
  Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92-0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24-11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57-63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82-0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0-20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods.
  
  
  CONCLUSIONS
  Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867
  
  
  METHODS
  I.
authors.affiliation: From the Gynuity Health Projects, New York, New York; Magee Womens Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania; Planned Parenthood of Waco, Waco, Texas; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Whole Woman's Health, Austin, Texas; Family Planning Associates Medical Group, Chicago, Illinois; Parkmed, New York, New York; and Institute for Urban Family Health, New York, New York.
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
authors.forename: Ilana G
authors.initials: IG
authors.lastname: Dzuba
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.forename: William A
authors.initials: WA
authors.lastname: Crowden
authors.forename: Alisa B
authors.initials: AB
authors.lastname: Goldberg
authors.forename: Juliana
authors.initials: J
authors.lastname: Gonzales
authors.forename: Michelle
authors.initials: M
authors.lastname: Howe
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Moskowitz
authors.forename: Linda
authors.initials: L
authors.lastname: Prine
authors.forename: Caitlin S
authors.initials: CS
authors.lastname: Shannon
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000278:Administration, Buccal; D000284:Administration, Oral; D004359:Drug Therapy, Combination; D005260:Female; D005865:Gestational Age; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone