Ireland
--:--IST
Recruiting Not applicable

Cervical Ripening Balloons for Same-Day Cervical Prep

NCT06964373 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2025-04-08
Last updated
2026-07-06

Condition(s) studied

Dilation and Evacuation

Investigational drug(s) / intervention(s)

Cervical Ripening BalloonOsmotic Dilators

Cervical Ripening Balloon: 30 milliliter Foley balloon

Osmotic Dilators: Dilapan-S

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Medical conditions that require procedural management in the operating room * Preference for D\&E procedure in the operating room

Primary outcome measure(s)

  • D&E procedure length (minutes) — during procedure
    From insertion of first instrument to removal of speculum

Trial sites (1)

FacilityCityRegionStatus
University of New Mexico Albuquerque New Mexico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06964373 on ClinicalTrials.gov ↗ ← All trials in Mexico