Foley Balloon for Cervical Preparation Before Dilation and Evacuation

Not Applicable

Recruiting

• Conditions: Abortion, Second Trimester; Abortion, Medical
• Interventions: Device: Foley Balloon Catheter; Device: Laminaria; Drug: Misoprostol

• Registration Number: NCT06850974
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-10
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley Balloon and misoprostol	Foley Balloon Catheter	Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol
Foley Balloon and misoprostol	Misoprostol	Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol
Laminaria	Laminaria	Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol

Primary Outcome Measures

Name	Time	Method
Total Procedure Time (TPT)	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.

Secondary Outcome Measures

Name	Time	Method
Initial pre-operative cervical dilation	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.
D&E operative time (OT)	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.
Potential Complications	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).
Provider Satisfaction Questionnaire	through study completion, an average of 1-2 days	Providers will describe satisfaction by responding to questionnaire regarding cervical preparation.
Visual Analogue Pain Scale	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.
Patient Satisfaction Questionnaire	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.

Trial Locations

Locations (1)

Hospital Central De Maputo; 🇲🇿 Maputo, Mozambique