title: A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion.
abstract: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-daysecond-trimester dilation and evacuation (D&E).
  
  
  
  Women desiring abortion between gestational ages 14weeks 0days and 19weeks 6days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6h prior to D&E. Primary outcome was cervical dilation assessed by largest Hegar dilator passed without resistance. Secondary outcomes included total procedure time and participant and provider perceptions. We had 90% power to detect a 2-mm change in initial cervical dilation with a mean of 10mm (SD=3.0mm), requiring 48 participants in each arm.
  
  
  
  Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4weeks, SD=1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI=-0.4, 2.0mm]. We found total procedure times of 11.8 and 13.0min, respectively (difference of 1.2min [95% CI=-2.4, 4.8min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications.
  
  
  
  The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6h prior to D&E at 14weeks through 19weeks 6days.
  
  
  
  Adding mifepristone for a short interval (4-6h) did not improve cervical preparation with misoprostol prior to D&E at 14-19weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.
authors.affiliation: Virginia Commonwealth University Medical Center, Richmond, VA, USA. Electronic address: frances.casey@vcuhealth.org.
authors.forename: Frances E
authors.initials: FE
authors.lastname: Casey
authors.affiliation: MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Peggy P
authors.initials: PP
authors.lastname: Ye
authors.affiliation: Planned Parenthood Metropolitan Washington, Washington, DC, USA.
authors.forename: Jamila D
authors.initials: JD
authors.lastname: Perritt
authors.affiliation: Dominican Hospital, Santa Cruz, CA, USA.
authors.forename: Nilda L
authors.initials: NL
authors.lastname: Moreno-Ruiz
authors.affiliation: MedStar Washington Hospital Center, Washington, DC, USA; Planned Parenthood Metropolitan Washington, Washington, DC, USA; National Abortion Federation, Washington, DC, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Reeves
mesh_terms: D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000293:Adolescent; D000328:Adult; D005260:Female; D005865:Gestational Age; D006801:Humans; D007747:Labor Stage, First / Q000187:drug effects*; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D014481:United States; D055815:Young Adult
chemical_list: D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone
keywords: Abortion; Dilation and evacuation; Mifepristone; Misoprostol