Cervical Ripening Balloons for Same-Day Cervical Prep

NCT ID: NCT06964373

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Dilation and Evacuation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cervical Ripening Balloon

Group Type EXPERIMENTAL

Cervical Ripening Balloon

Intervention Type DEVICE

30 milliliter Foley balloon

Osmotic Dilators

Group Type ACTIVE_COMPARATOR

Osmotic Dilators

Intervention Type DEVICE

Dilapan-S

Interventions

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Cervical Ripening Balloon

30 milliliter Foley balloon

Intervention Type DEVICE

Osmotic Dilators

Dilapan-S

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Cervical Ripening Balloon Study Coordinator

Role: primary

505-205-4118

Other Identifiers

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24-493

Identifier Type: -

Identifier Source: org_study_id

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