Actively Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Led by Stony Brook University ยท Updated on 2026-04-30
102
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the Foley Balloon technique combined with misoprostol for preparing the cervix before second trimester surgical abortion between 16 and 21 weeks gestational age. The study compares this method to the standard use of osmotic dilators (Laminaria) to assess if the Foley Balloon and misoprostol approach is not worse than the usual method. Additionally, the study will explore patient and provider satisfaction with both cervical preparation methods. Participants are randomly assigned to one of two groups. One group will receive a Foley Balloon catheter placed trans-cervically, inflated with saline, along with buccal misoprostol. The other group will have Laminaria devices placed in the cervix according to gestational age. Cervical preparation typically occurs on the first day, followed by dilation and evacuation (D&E) on the second day to complete the abortion procedure. Participants will undergo the cervical preparation procedure followed by D&E, with assessments including total procedure time, operative time, cervical dilation, complication rates, and pain levels. Satisfaction questionnaires will be completed by both patients and providers. The study spans the preparation and procedure days, with monitoring for safety and effectiveness outcomes. The total procedure time will be about 15-20 minutes during D&E completion, while complications and satisfaction are evaluated over 1-2 days.
CONDITIONS
Brief Title
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years and older requiring abortion for legal reasons between 16 and 21 weeks gestation
- Portuguese speaking
You will not qualify if you...
- Under 18 years old
- Incarcerated individuals
- Presence of chorioamnionitis
- Active heavy bleeding
- Known bleeding disorders
- Hemodynamic instability
- Cervical dilation greater than 2 cm
- History of cervical cerclage
- Allergy to study medications
- Eclampsia
- Glasgow Coma Score less than 15
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants receive cervical preparation using either a Foley Balloon catheter with misoprostol or Laminaria to soften and dilate the cervix before the procedure.
1 visit (in-person)
Duration - Approximately 15 to 20 minutes
Participants undergo the dilation and evacuation procedure to complete the termination of pregnancy.
1 visit (in-person)
Duration - 1 to 2 days
Participants are monitored for potential complications and complete satisfaction questionnaires following the procedure.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Hospital Central De Maputo
Maputo, Mozambique
Actively Recruiting
Research Team
S
Sierra Washington, MD MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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