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Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Sponsor: Stony Brook University
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-02-10
Completion Date
2027-03
Last Updated
2025-02-28
Healthy Volunteers
No
Interventions
Foley Balloon Catheter
18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.
Misoprostol
400 mcg of buccal misoprostol sublingual
Laminaria
Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.
Locations (1)
Hospital Central De Maputo
Maputo, Cidade de Maputo, Mozambique