Preparing the cervix for same-day second‑trimester D&E
Official title: Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
Run by Boston Medical Center · NCT06799052 · Data updated 2026-11-12
This research tests whether a single‑balloon catheter works as well as osmotic dilators to prepare the cervix for same‑day D&E in people 16 weeks 0 days to 18 weeks 6 days pregnant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 32 (estimated) |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT06799052 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People seeking termination with a singleton intrauterine pregnancy at 16 weeks 0 days through 18 weeks 6 days who can give informed consent and speak English or Spanish may be eligible.
✕Probably not a fit
Patients with allergy to the devices or related materials, fetal demise or known fetal anomaly, BMI over 45, incarcerated individuals, or those who choose overnight dilation are not eligible and would not benefit from participation.
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 single‑center, randomized noninferiority trial comparing transcervical single‑balloon catheter cervical preparation to synthetic osmotic dilators for same‑day dilation and evacuation at 16 0/7–18 6/7 weeks gestation. Participants are randomly assigned to one of the two cervical preparation methods before attempting a same‑day D&E. The primary outcome is D&E operative time, and secondary outcomes include adequacy of dilation, ability to complete the operation the same day, participant pain, satisfaction, and safety. Eligible participants must be able to consent, speak English or Spanish, and have a singleton intrauterine pregnancy; several exclusions apply such as allergy to device materials, fetal demise or anomaly, and BMI >45.
Why it matters
Potential benefit: If successful, the single‑balloon catheter approach could allow as-effective cervical preparation with similar safety and satisfaction while enabling same‑day D&E for eligible patients.
How similar studies have gone: Osmotic dilators are an established method for cervical preparation, while the use of a transcervical single‑balloon catheter for same‑day D&E has more limited direct evidence and is being compared here for noninferiority.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period) * Able to provide informed consent * English- or Spanish-speaking * Singleton intrauterine pregnancy Exclusion Criteria: * Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators * Fetal demise or known fetal anomaly * BMI \>45 * Incarceration or other inability to give informed consent * Decide to undergo cervical preparation overnight prior to next-day D\&E
Where it's running
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Boston Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Anjanique Mariquit Lu, MD — Boston Medical Center, Obstetrics and Gynecology
- Study coordinator: Anjanique Mariquit Lu, MD
- Email: anjaniquemariquit.lu@bmc.org
- Phone: 617 414 5716
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.