Foley Balloon for Cervical Preparation Before Dilation and Evacuation

April 26, 2026 updated by: Sierra Washington, Stony Brook University

To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D&E) instead of osmotic dilators (Laminaria).

Specific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D&E.

Specific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion.

Specific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Termination of pregnancy was legalized in Mozambique in 2016 for any reason until 12 weeks, and up 16 weeks in cases of rape, and at any time for cases of fetal demise, severe fetal anomaly, or to protect a woman's physical or mental health. It is also legal up until 24 weeks in the case of a chronic infectious or degenerative disease. Termination of pregnancy can be accomplished either by induction of labor or by Dilation and Evacuation (D&E). Typically, D&E after 16 weeks is a two-day procedure. The first day is devoted to cervical preparation, where osmotic dilators are placed into the cervix and allowed to slowly soften and dilate the cervix. On the second day of the procedure the uterus is evacuated. Osmotic dilators are expensive and unavailable in most of Sub-Saharan Africa. An alternative strategy to cervical preparation has recently been developed by Dr. Yashica Robinson and has been described in a retrospective cohort study. This new technique involves using a Foley Catheter balloon (FB) inserted into the cervix to dilate the cervix over several hours with buccal misoprostol as an adjunct medication. After which, the procedure is completed using the dilation and evacuation procedure. However, Foley Balloon for cervical preparation before dilation and evacuation is still considered investigational. Both Foley Balloon and misoprostol are low cost and widely available in Africa and thus may be a safe and efficacious alternative to osmotic dilators. These two strategies of cervical preparation have never been directly compared in a prospective randomized clinical trial. This study aims to conduct a randomized controlled trial to evaluate the Foley Balloon for cervical preparation before D&E. Specifically, our objective is to evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age. The investigators propose to conduct a randomized controlled non-inferiority trial to compare procedure difficulty, complication rates, provider satisfaction, and patient satisfaction with a novel technique to prove that the Foley Balloon and misoprostol method is safe, effective, and acceptable to providers and patients.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mozambique
      • Maputo, Mozambique
        • Recruiting
        • Hospital Central De Maputo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sierra Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
  • Portuguese speaking

Exclusion Criteria:

  • Less than age 18
  • Incarcerated
  • Chorioamnionitis
  • Active heavy bleeding
  • A known bleeding diathesis
  • Hemodynamic instability
  • > 2 cm dilation
  • History of cervical cerclage
  • Allergy to any study medications
  • Eclampsia
  • Glasgow Coma Score Less than 15

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foley Balloon and misoprostol
Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol
Device: Foley Balloon Catheter
18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.
Drug: Misoprostol
400 mcg of buccal misoprostol sublingual
Active Comparator: Laminaria
Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol
Device: Laminaria
Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Procedure Time (TPT)
Time Frame: through completion of D&E, approximately 15-20 minutes
Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing Total Procedure Time (TPT) of dilation and evacuation (D&E) procedure.
through completion of D&E, approximately 15-20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D&E operative time (OT)
Time Frame: through completion of D&E, approximately 15-20 minutes
Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing D&E operative time (OT) of dilation and evacuation (D&E) procedure.
through completion of D&E, approximately 15-20 minutes
Initial pre-operative cervical dilation
Time Frame: through completion of D&E, approximately 15-20 minutes
Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing the initial pre-operative cervical dilation during the dilation and evacuation (D&E) procedure.
through completion of D&E, approximately 15-20 minutes
Potential Complications
Time Frame: through completion of the D&E, an average of 1-2 days
Determine any potential same day complication rates between the foley balloon arm (foley balloon and misoprostol) versus the laminaria arm (laminaria only).
through completion of the D&E, an average of 1-2 days
Visual Analogue Pain Scale
Time Frame: through completion of the D&E, an average of 1-2 days.
Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing the pain rating before and after dilation and evacuation (D&E) procedure. Patient will complete a short survey, the Visual Analogue Pain Scale to rate their pain. The Minimum value of 0 and Maximum value of 10 where the higher value indicates more pain or worse outcome.
through completion of the D&E, an average of 1-2 days.
Provider Satisfaction Questionnaire
Time Frame: through study completion, an average of 1-2 days
Providers will describe satisfaction by responding to questionnaire regarding cervical preparation.
through study completion, an average of 1-2 days
Patient Satisfaction Questionnaire
Time Frame: through completion of the D&E, an average of 1-2 days
Patients will describe satisfaction by responding to questionnaire regarding satisfaction with the cervical preparation procedure.
through completion of the D&E, an average of 1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023-00297
  • stony brook university (Other Identifier: stony brook university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identifed patient database will be shared

IPD Sharing Time Frame

1/2026-1/2046

IPD Sharing Access Criteria

Independent validated investigators, peer reviewed journal editors will be able to access the study protocol, the data analysis plan and the de-identified database should they wish to perform a meta- analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abortion, Second Trimester

Clinical Trials on Foley Balloon Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe