Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Launched by STONY BROOK UNIVERSITY · Feb 25, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a Foley Balloon combined with a medication called misoprostol to prepare the cervix for a specific type of abortion called dilation and evacuation (D&E) in women who are between 16 to 21 weeks pregnant. The goal is to find out if this method is as effective and safe as the traditional method, which uses osmotic dilators (Laminaria). Additionally, the trial will assess how satisfied both patients and healthcare providers are with these two different approaches.
To participate in the trial, women must be at least 18 years old and able to speak Portuguese, and they should be seeking an abortion for any legal reason within the specified gestational age. However, there are some exclusions; for example, women who are experiencing certain medical conditions or have had specific previous surgeries may not be eligible. Participants can expect to receive either the Foley Balloon or the traditional method as part of their care, and they will be asked about their experiences and satisfaction with the process. This study will help improve care for women undergoing second-trimester abortions.
Gender
FEMALE
Eligibility 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
About Stony Brook University
Stony Brook University, a prominent research institution located in New York, is dedicated to advancing medical science through innovative clinical trials and research initiatives. As a sponsor, Stony Brook University leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient care and health outcomes. With a commitment to ethical standards and collaborative partnerships, the university fosters an environment conducive to groundbreaking discoveries and the translation of research findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Maputo, , Mozambique
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported