Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456164
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-19
Brief Title:
IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion CERBI a Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CERBI
Brief 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 ie mifepristone at least 24 hours prior to administration of sublingual buccal or vaginal prostaglandins eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None