RecruitingNot ApplicableNCT06850974

Foley Balloon for Cervical Preparation Before Dilation and Evacuation


Sponsor

Stony Brook University

Enrollment

102 participants

Start Date

Feb 10, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of preparing the cervix (the lower opening of the uterus) before a dilation and evacuation (D&E) procedure — a common second-trimester abortion method. The study compares a Foley balloon catheter to another standard preparation method, to see which is safer, more effective, and more acceptable. **You may be eligible if...** - You are a woman aged 18 years or older - You are presenting to Hospital Central de Maputo for an abortion that is legal in Mozambique - You are between 16 and 21 weeks pregnant - You speak Portuguese **You may NOT be eligible if...** - You are under 18 years old - You are currently incarcerated - You have a uterine or amniotic infection (chorioamnionitis) - You are bleeding heavily - You have a known bleeding disorder - You are hemodynamically unstable (in circulatory shock) - Your cervix is already more than 2 cm dilated - You have a history of cervical cerclage (a stitch placed in the cervix) - You have a known allergy to the comparison preparation method Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFoley Balloon Catheter

18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.

DRUGMisoprostol

400 mcg of buccal misoprostol sublingual

DEVICELaminaria

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, Mozambique

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NCT06850974


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