Cervical preparation with mifepristone prior to osmotic dilators: A randomized, double-blind, placebo-controlled trial
Awarded 2019
Complex Family Planning Fellowship Research
Suji Uhm, MD, MPH
University of California, Davis

No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. I plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 women will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a dilation and evacuation procedure. Enrollees will be 20 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. We will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, and pre-viable delivery prior to procedure.