RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation. (NCT07200115) | Clinical Trial Compass
RecruitingNot Applicable
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
United States50 participantsStarted 2025-12-03
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Cervical Dilation
Timeframe: Day 1 (cervical preparation visit) to Day 2 (D&E)