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
Inclusion Criteria2
- 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 Criteria11
- 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
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