|

Foley Balloon for Cervical Preparation Before Dilation and Evacuation

RECRUITINGN/ASponsored by Stony Brook University
Actively Recruiting
PhaseN/A
SponsorStony Brook University
Started2025-02-10
Est. completion2027-03
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06850974

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

Abortion, MedicalAbortion, Second TrimesterCancer

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.