Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks

This study will use a prospective, double-blind, randomized clinical trial design. As our main objective is to determine whether one pharmacological method of cervical preparation is more effective than the other in our population, this is the most appropriate study design. A double-blinded, randomized trial will allow for the maximal prevention of bias affecting study results. The study will be structured as a two-tailed comparison, as it is possible that mifepristone is significantly less effective than misoprostol in effecting initial cervical dilation. While previous studies have indicated that mifepristone is superior to misoprostol in this regard, our study focuses on a later gestational age range. Therefore, we believe that a one-tailed comparison would be inappropriate to test whether there is a difference between mifepristone and misoprostol as cervical preparing agents in our gestational age range.

We will enroll approximately 50 subjects between 11 0/7 and 15 0/7 weeks GA seeking abortion and randomize them into two groups in a 1:1 ratio. Group A subjects will receive mifepristone 200 mg capsulized orally at the time of their preoperative visit and be given two folic acid tablets (misoprostol placebo) to place buccally on the day of their procedure. Group B subjects will receive empty capsules (mifepristone placebo) orally at the time of their preoperative visit and be given two misoprostol 200 mcg tablets to place buccally on the day of their procedure.

To preserve blinding, we will place mifepristone in capsules provided by the BMC IDS. Subjects not receiving mifepristone will receive identically-appearing empty capsules.

The study will take place at Boston Medical Center's outpatient Women's Care Center. Preoperative appointments will take place in the Pre-Procedure Unit (PPU) and abortion appointments will take place in the Gynecology Procedures Unit (GPU). Patients seeking abortion services at BMC will constitute the population that will be the source of the study sample. Because we seek to investigate mifepristone and misoprostol as cervical preparants in the population of women seeking abortion services, this is an appropriate population from which to sample.

Patients who are eligible to enroll as subjects in the investigation will be identified by the clinical provider who sees them for their preoperative visit. Approximately 20 patients per month seen at our clinic meet the criteria for inclusion into the study. The provider will describe the study briefly to the potential subject, and if they are interested, the provider will contact study staff. The staff member will describe the study in greater detail and obtain informed consent to take part in the study.