Status:
NOT_YET_RECRUITING
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
Lead Sponsor:
Yale University
Conditions:
Cervical Preparation Prior to Dilation and Evacuation
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for...
Detailed Description
This study is a two-arm, non-blinded, randomized controlled trial of a cervical ripening double balloon (CRDB) catheter compared to osmotic dilators (e.g., laminaria and/or Dilapan-S) for overnight ce...
Eligibility Criteria
Inclusion
- Singleton pregnancy between 19 weeks 0 days to 23 weeks 6 days GD.
- Planning to undergo D\&E with Yale Family Planning and has undergone standard informed clinical consent counseling for the procedure and signed the clinical procedure consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the active part of the study.
- English- or Spanish-speaking individual.
- Residents of the state of Connecticut.
Exclusion
- Spontaneous or induced fetal demise.
- Multiple pregnancy.
- Preterm prelabor rupture of membranes (PPROM).
- Intraamniotic infection.
- Active genital tract infection.
- Active vaginal bleeding.
- Placenta previa or vasa previa.
- Placenta accreta spectrum.
- History of \>3 cesarean deliveries.
- BMI \>45 kg/m2.
- Contraindication to osmotic cervical dilator or CRDB catheter use as determined by the physician.
- Contraindication to medication used during standard of care cervical preparation.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07200115
Start Date
November 1 2025
End Date
September 1 2028
Last Update
October 29 2025
Active Locations (1)
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1
Yale Family Planning Clinic
New Haven, Connecticut, United States, 06519