Recruiting

Cervical Ripening Balloon vs. Osmotic Dilators

Sponsor:

University of New Mexico

Code:

NCT06964373

Conditions

Dilation and Evacuation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cervical Ripening Balloon

Osmotic Dilators

Study Details

Brief 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

Conditions

Dilation and Evacuation

Study ID

NCT06964373

Start date

Apr 8, 2025

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cervical Ripening Balloon

active comparator: Osmotic Dilators

Interventions

Cervical Ripening Balloon

30 milliliter Foley balloon

Osmotic Dilators

Dilapan-S

Primary outcome measure

  • D&E procedure length (minutes) [ Time Frame: during procedure ]

Central Contacts and Locations

Locations

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Cervical Ripening Balloon Study Coordinator

505-205-4118HSC-FamilyPlanningResearch@salud.unm.edu

More Information

Sponsor

University of New Mexico

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.