NCT06850974 Foley Balloon for Cervical Preparation Before Dilation and Evacuation
| NCT ID | NCT06850974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stony Brook University |
| Condition | Abortion, Second Trimester |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2025-02-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Frequently Asked Questions
Who can join the NCT06850974 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Abortion, Second Trimester. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06850974 currently recruiting?
Yes, NCT06850974 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stony Brook University to inquire about joining.
Where is the NCT06850974 trial being conducted?
This trial is being conducted at Maputo, Mozambique.
Who is sponsoring the NCT06850974 clinical trial?
NCT06850974 is sponsored by Stony Brook University. The trial plans to enroll 102 participants.