Foley Balloon for Cervical Preparation Before Dilation and Evacuation

NCT ID: NCT06850974

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2027-03-31

Brief 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.

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.

Conditions

Abortion, Second Trimester; Abortion, Medical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Foley Balloon Catheter

Intervention Type: DEVICE

18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.

Misoprostol

Intervention Type: DRUG

400 mcg of buccal misoprostol sublingual

Laminaria

Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol

Group Type: ACTIVE_COMPARATOR

Laminaria

Intervention Type: DEVICE

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

Interventions

Foley Balloon Catheter

18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.

Intervention Type: DEVICE

Misoprostol

400 mcg of buccal misoprostol sublingual

Intervention Type: DRUG

Laminaria

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Sierra Washington

MD, Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Central De Maputo

Maputo, Cidade de Maputo, Mozambique

Site Status: RECRUITING

Countries

Mozambique

Central Contacts

Sierra Washington, MD MSc

Role: CONTACT

sierra.washington@stonybrookmedicine.edu

+258 84 147 7208

Facility Contacts

Sibone Mocumbi, MD PhD

Role: primary

sibone@yahoo.com

+258 843250540

Sierra Washington, MD Msc

Role: backup

sierra.washington@stonybrook.edu

+258 841477208

Other Identifiers

stony brook university

Identifier Type: OTHER

Identifier Source: secondary_id

IRB2023-00297

Identifier Type: -

Identifier Source: org_study_id