Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial
Montefiore Medical Center
Summary
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.
Description
Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experi…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * English or Spanish-speaking * Capacity to consent * Seeking induced abortion of a singleton pregnancy * Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery) Exclusion Criteria: * History of more than two prior Cesarean deliveries * Sonographic evidence of placenta previa * Sonographic concern for morbidly adherent placenta * Prior obstetric hemorrhage requiring transfusion * Obstructive cervical or lower uterine segment fibroid * Current therapeutic anticoagulation use * Cerclage in situ * History of more than one prior cervical excisional pro…
Interventions
- DrugMifepristone
200 milligrams (mg)
- DrugMisoprostol
600 micrograms (ug)
Location
- Montefiore Medical CenterThe Bronx, New York