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RECRUITING
NCT06964373
NA

Cervical Ripening Balloons for Same-Day Cervical Prep

Sponsor: University of New Mexico

View on ClinicalTrials.gov

Summary

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

Official title: Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-04-08

Completion Date

2026-07-31

Last Updated

2025-05-09

Healthy Volunteers

No

Interventions

DEVICE

Cervical Ripening Balloon

30 milliliter Foley balloon

DEVICE

Osmotic Dilators

Dilapan-S

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States