Overnight double-balloon catheter for cervical ripening before dilation and evacuation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-blinded, randomized, two-arm trial comparing an overnight cervical ripening double balloon (CRDB) catheter to overnight osmotic dilators (e.g., laminaria or Dilapan‑S) for cervical preparation prior to dilation and evacuation at 19+0 to 23+6 weeks. Eligible, English- or Spanish-speaking Connecticut residents planning a D&E at Yale Family Planning are randomized 1:1 using blocked allocation and informed of their assignment before the procedure. The CRDB uterine balloon is inflated 20–40 mL based on tolerance while osmotic dilators are placed per physician preference; neither physicians nor patients are masked. The primary outcome is mean cervical dilation measured immediately before the D&E, with additional data collected on need for further dilation and procedure-related outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale Family Planning Clinic
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Tessa Madden, MD — Yale University
• Study coordinator: Yale Family Planning
• Email: fpresearch@yale.edu
• Phone: 203-785-5074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.