Status:
RECRUITING
Mifepristone vs Misoprostol
Lead Sponsor:
Montefiore Medical Center
Conditions:
Cervical Preparation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 ca...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06502158
Start Date
October 31 2024
End Date
October 1 2026
Last Update
August 13 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467