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Foley Balloon for Cervical Preparation Before Dilation and Evacuation

NCT06850974 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Abortion, Second Trimester
  • Abortion, Medical

Interventions

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

DEVICE

Laminaria

Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • Mozambique

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850974 on ClinicalTrials.gov