Foley Balloon for Cervical Preparation Before Dilation and Evacuation

Recruiting now · Not applicable

Conditions studied: Abortion, Second Trimester, Abortion, Medical

In brief

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 facts

Study ID

NCT06850974

Run by

Stony Brook University

People needed

102

Starts

2025-02-10

Expected to finish

2027-03-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Hospital Central De Maputo — Maputo, Mozambique (enrolling)

Full record on ClinicalTrials.gov

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