Home › Pathologic Dilatation › NCT07200115

RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.

Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial

Who can join

Ages 18 and older · Women

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.

About the study

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.

What is being tested

• Cervical Ripening Double Balloon (CRDB) Catheter (device)
• Osmotic Dilators (device)

Sponsor: Yale University · Participants: 50 · Started: Dec 3, 2025

Contact the study team

• Yale Family Planning · Phone: 203-785-5074

Official record on ClinicalTrials.gov — NCT07200115

Locations in the U.S.

Conditions

• Pathologic Dilatation

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.