NCT06456164

IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion

IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to understand whether it is practical and safe to use an intracervical balloon catheter in addition to standard of care medications at the time of an induction of labor for an abortion or fetal death. The medical device used in this study is cleared by the Food and Drug Administration (FDA) and is used for induction of labor at term gestational ages (at or above 37 weeks of gestation). The study team will also collect data about patient-level experiences with the procedure, time in labor, and labor-related complications, such as higher-than-expected blood loss or infection.

Detailed description

Commonly, induction of labor in the second trimester is accomplished with the use of oral anti-progestin medications (i.e., mifepristone) at least 24 hours prior to administration of sublingual, buccal, or vaginal prostaglandins (e.g., misoprostol). Innovation over the past decade has largely been focused on the concomitant use of mechanical dilation for induction of labor in order to reduce the time from initiation of labor to delivery. However, limited data exist to demonstrate the efficacy of an intracervical balloon catheter during second-trimester induction of labor. Therefore, the principal investigator seeks to conduct a feasibility randomized controlled trial to evaluate whether an intracervical balloon catheter - commonly used for inductions of labor at later gestational ages - can be used during second-trimester inductions of labor.

Conditions

• Abortion, Complete
• Fetal Death
• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DEVICE	Cook Cervical Ripening Balloon	The Cook Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction when the cervix is unfavorable for induction.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2024-06-13
• Last updated: 2025-06-06

Regulatory

• FDA-regulated device study