Julie Chor, John H. Stroger Jr. Hospital of Cook County, 2011
Project abstract
Background: Compared to a two-day procedure, same-day cervical preparation for early second trimester offers benefits both to women seeking abortion and providers of abortion. These benefits include: decreasing time away from work or family, decreasing time and cost of transportation, and eliminating the risk of women failing to return to the clinic after having osmotic dilators placed. While several studies have evaluated the efficacy of osmotic dilators and misoprostol in cervical preparation for early second trimester surgical abortion, no studies have been published that directly compare outcomes for Dilapan-S® versus buccal misoprostol for same-day cervical preparation.
Objectives: Our primary objective is to assess the efficacy of both buccal misoprostol and Dilapan-S® for cervical preparation for same day surgical termination between 14 to 15 6/7 weeks gestation, as measured by pre-procedural cervical dilation. Our secondary objectives are to assess patient acceptability, procedure efficiency, and additional measures of efficacy including the need for mechanical dilation and provider assessment of difficulty of procedure.
Design and methodology: This project is a single blinded randomized trial randomizing 50 women either to Dilapan-S® 4 hours prior or 400 mcg buccal misoprostol 2-4 hours prior to same day surgical termination between 14 0/7 and 15 6/7 weeks gestation. Physicians performing the procedure will be blinded to the treatment arm. Sample size was calculated to obtain 80% power with an alpha of 0.05 to detect a difference of 6-mm circumference.
Rationale: We seek to provide first trimester abortion providers compelling evidence regarding efficacy and acceptability of two methods of same day cervical preparation that will enable them to expand their practices to include early second trimester terminations. By potentially expanding the pool of second trimester providers, we seek to increase women’s access to this important service.
