Actively Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Led by Stony Brook University · Updated on 2026-04-30
102
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
- Portuguese speaking
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Central De Maputo
Maputo, Mozambique
Actively Recruiting
Research Team
S
Sierra Washington, MD MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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