Overnight double-balloon catheter for cervical ripening before dilation and evacuation
Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial
This will test whether using an overnight double-balloon catheter works better than overnight osmotic dilators to prepare the cervix for people having a second‑trimester D&E.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07200115 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English- or Spanish-speaking Connecticut residents with a singleton pregnancy at 19 weeks 0 days to 23 weeks 6 days who are planning a D&E at Yale Family Planning and have no contraindications to either device.
Not a fit: People with fetal demise, multiple pregnancy, PPROM, intraamniotic infection or active genital tract infection, active vaginal bleeding, placenta previa/vasa previa or placenta accreta spectrum, BMI >45, more than three prior cesarean deliveries, or other physician-determined contraindications may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the double-balloon approach could produce larger or more consistent overnight cervical dilation, potentially reducing procedure time, need for extra dilation, and related discomfort or complications.
How similar studies have performed: CRDB catheters are FDA-cleared for term labor cervical ripening and osmotic dilators are standard for D&E preparation, but randomized evidence for CRDB use specifically in the second trimester is limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.