Using a Foley Balloon for cervical preparation before second trimester abortion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.