RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
Recruiting
N/A
Interventional Study
Cervical Preparation Prior to Dilation and Evacuation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Yale University · Other
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About This Trial
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 dil…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 com…
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