RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
Recruiting now · Not applicable
Conditions studied: Cervical Preparation Prior to Dilation and Evacuation
In brief
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 patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device for cervical dilation prior to labor induction at term. It has not been FDA cleared for cervical dilation in the second-trimester, however, will be used in a similar fashion to labor inductions at term. Our standard of care osmotic dilators (e.g., laminaria, Dilapan-S) are both FDA cleared for cervical dilation prior to labor induction at term or gynecologic procedures requiring cervical dilation.
Key facts
- Study ID
- NCT07200115
- Run by
- Yale University
- People needed
- 50
- Starts
- 2025-12-03
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Yale Family Planning Clinic — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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