Comparing mifepristone and misoprostol for cervical preparation in abortions
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
This study tests whether mifepristone or misoprostol is better for preparing the cervix in people having abortions between 12 to 16 weeks of pregnancy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06502158 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of mifepristone versus misoprostol for cervical preparation in patients undergoing procedural abortions between 12 to 16 weeks of gestation. The study will randomly assign participants to receive either mifepristone or misoprostol and assess the success rate of cervical dilation in each group. Given the importance of cervical preparation in reducing surgical complications, this trial seeks to identify the most effective and patient-friendly option for this critical procedure. The findings could influence clinical practices and improve patient experiences during abortion care.
Who should consider this trial
Good fit: Ideal candidates for this study are English or Spanish-speaking individuals seeking an induced abortion of a singleton pregnancy between 12 weeks and 16 weeks gestation.
Not a fit: Patients with a history of multiple Cesarean deliveries, certain placental conditions, or significant obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cervical preparation methods, enhancing safety and comfort for patients undergoing procedural abortions.
How similar studies have performed: Previous studies have shown mifepristone's efficacy as a cervical ripening agent, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 procedure * BMI greater than 50 kg/m\^2
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Antoinette Danvers, MD, MSCR, MBA — Montefiore Medical Center
- Study coordinator: Laura Fletcher, MD, MPH
- Email: lfletcher@montefiore.org
- Phone: 516-587-3297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.