NCT06799052 Cervical Preparation for Same-Day Dilation & Evacuation
| NCT ID | NCT06799052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Abortion, Second Trimester |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Eligibility 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
Contact & Investigator
Anjanique Mariquit Lu, MD
PRINCIPAL INVESTIGATOR
Boston Medical Center, Obstetrics and Gynecology
Frequently Asked Questions
Who can join the NCT06799052 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Abortion, Second Trimester. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799052 currently recruiting?
Yes, NCT06799052 is actively recruiting participants. Contact the research team at anjaniquemariquit.lu@bmc.org for enrollment information.
Where is the NCT06799052 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06799052 clinical trial?
NCT06799052 is sponsored by Boston Medical Center. The principal investigator is Anjanique Mariquit Lu, MD at Boston Medical Center, Obstetrics and Gynecology. The trial plans to enroll 32 participants.