Actively Recruiting
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
Led by Yale University · Updated on 2026-02-05
50
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy between 19 weeks 0 days to 23 weeks 6 days gestation
- Planning to have dilation and evacuation (D&E) with Yale Family Planning and have signed informed consent for the procedure
- Willing to comply with all study procedures and be available during the active study
- Able to speak English or Spanish
- Resident of the state of Connecticut
You will not qualify if you...
- Pregnancy with 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 more than 3 cesarean deliveries
- Body mass index (BMI) greater than 45 kg/m2
- Contraindication to osmotic cervical dilators or CRDB catheter use as determined by the physician
- Contraindication to medications used during standard cervical preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale Family Planning Clinic
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
Y
Yale Family Planning
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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