Clinical trial NCT06850974: Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Official title: Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abortion, Second Trimester
Abortion, Medical
Keywords: second
trimester
abortion
surgical
balloon
Foley
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Procedure Time (TPT)
timeFrame: through completion of D&E, approximately 15-20 minutes
Secondary outcomes:
measure: D&E operative time (OT)
timeFrame: through completion of D&E, approximately 15-20 minutes
measure: Initial pre-operative cervical dilation
timeFrame: through completion of D&E, approximately 15-20 minutes
measure: Potential Complications
timeFrame: through completion of the D&E, an average of 1-2 days
measure: Visual Analogue Pain Scale
timeFrame: through completion of the D&E, an average of 1-2 days.
measure: Provider Satisfaction Questionnaire
timeFrame: through study completion, an average of 1-2 days
measure: Patient Satisfaction Questionnaire
timeFrame: through completion of the D&E, an average of 1-2 days
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Hospital Central De Maputo
Study officials:
References: