Recruiting

CRDB Catheter

Sponsor:

Yale University

Code:

NCT07200115

Conditions

Cervical Preparation Prior to Dilation and Evacuation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cervical Ripening Double Balloon (CRDB) Catheter

Osmotic Dilators

Study Details

Brief 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.

Conditions

Cervical Preparation Prior to Dilation and Evacuation

Study ID

NCT07200115

Start date

Dec 3, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cervical Ripening Double Balloon (CRDB) Catheter

active comparator: Osmotic Dilators

Interventions

Cervical Ripening Double Balloon (CRDB) Catheter

The physician will place a CRDB catheter for overnight cervical preparation. The CRDB catheter is comprised of two balloons that can be inflated with up to 80 mL of sterile water.

Osmotic Dilators

Osmotic dilators (e.g., laminaria and Dilapan-S) are mechanical dilators that are placed in the cervix prior to gynecologic procedures and facilitate dilation through the slow absorption of moisture. The physician will place osmotic dilators in the standard fashion.

Primary outcome measure

  • Mean Cervical Dilation [ Time Frame: Day 1 (cervical preparation visit) to Day 2 (D&E) ]

Central Contacts and Locations

Central contacts

Yale Family Planning

203-785-5074fpresearch@yale.edu

Locations

Yale Family Planning Clinic

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Yale Family Planning

203-785-5074fpresearch@yale.edu

Principal Investigator:

Yale Family Planning

More Information

Sponsor

Yale University

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • cervical preparation
  • osmotic dilators
  • cervical ripening double balloon catheter
  • dilation and evacuation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-05.