Cervical Ripening Balloons for Same-Day Cervical Prep

Recruiting now · Not applicable

Conditions studied: Dilation and Evacuation

In brief

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are: * Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? Participants will: * Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure

Key facts

Study ID

NCT06964373

Run by

University of New Mexico

People needed

70

Starts

2025-04-08

Expected to finish

2027-07-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Individuals who desire outpatient dilation and evacuation (D\&E)
• At least 18 years of age
• Able and willing to consent
• Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound
• Able to read and understand English or Spanish
• Able to obtain reliable post-procedure transportation
• Able to observe fasting guidelines of 6 hours prior to the D\&E procedure

You may not qualify if…

• Medical conditions that require procedural management in the operating room
• Preference for D\&E procedure in the operating room

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

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