title: Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial.
abstract: This study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E).
  
  
  
  A randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S®) at least 4 h prior to D&E and were randomized to 400mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α=0.05, 80% power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications.
  
  
  
  Twenty-nine women were enrolled (misoprostol n=14, placebo n=15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p=.17). Complications were nonsignificantly more common for participants ≥19 weeks compared to <19 weeks (22% vs. 9%, p=.62) and those who received placebo compared to misoprostol (27% vs. 7%, p=.33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p=.03) and less cramping preoperatively (p<.01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98%).
  
  
  
  Adjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures.
  
  
  
  Although the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥19 weeks gestation.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States. Electronic address: cboraas@gmail.com.
authors.forename: Christy M
authors.initials: CM
authors.lastname: Boraas
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA 15213, United States.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Achilles
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States.
authors.forename: Miriam L
authors.initials: ML
authors.lastname: Cremer
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Chappell
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lim
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA 15213, United States; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA 15213, United States.
authors.forename: Beatrice A
authors.initials: BA
authors.lastname: Chen
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000028:Abortion, Induced / Q000379:methods*; D000328:Adult; D002584:Cervix Uteri / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007747:Labor Stage, First; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D010414:Pennsylvania; D011108:Polymers / Q000627:therapeutic use*; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D012044:Regression Analysis; D013997:Time Factors; D014619:Vacuum Curettage; D064232:Visual Analog Scale; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D011108:Polymers; D016595:Misoprostol; C077755:dilapan
keywords: Abortion, induced; Dilation and evacuation; Misoprostol; Second trimester