Using a Foley Balloon for cervical preparation before second trimester abortion
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
This study is testing if using a Foley Balloon with a medication can safely prepare the cervix for a second trimester abortion in women, and if it works just as well as the usual method that's hard to get in some areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Maputo) |
| Trial ID | NCT06850974 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Foley Balloon technique combined with misoprostol for cervical preparation prior to dilation and evacuation (D&E) in women seeking second trimester abortions between 16 and 21 weeks of gestation. The research aims to determine if this method is non-inferior to traditional osmotic dilators, which are often unavailable in Sub-Saharan Africa. Additionally, the study will assess patient and provider satisfaction with both methods. The goal is to provide a low-cost and accessible alternative for cervical preparation in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are Portuguese-speaking and require an abortion for any legal indication between 16 and 21 weeks of gestation.
Not a fit: Patients who are under 18, incarcerated, or have certain medical conditions such as chorioamnionitis or active heavy bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more accessible method for cervical preparation in second trimester abortions, particularly in resource-limited settings.
How similar studies have performed: While the Foley Balloon technique is considered investigational, preliminary studies suggest it may be a viable alternative to osmotic dilators, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maputo
- Hospital Central De Maputo — Maputo, Mozambique (Recruiting)
Study contacts
- Study coordinator: Sierra Washington, MD MSc
- Email: sierra.washington@stonybrookmedicine.edu
- Phone: +258 84 147 7208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.