Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Stony Brook University
102 participants
Feb 10, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.
400 mcg of buccal misoprostol sublingual
Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.
Locations(1)
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NCT06850974