Foley Balloon for Cervical Preparation Before Dilation and Evacuation (NCT06850974) | Clinical Trial Compass
RecruitingNot Applicable
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Mozambique102 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Procedure Time (TPT)
Timeframe: through completion of D&E, approximately 15-20 minutes