Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-06-02 @ 7:48 AM
Study NCT ID:
NCT03399266
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balloon Induction of Labor in PROM for TOLAC
Sponsor:
Soroka University Medical Center
Organization:
Study Overview
Official Title:
Mechanical Induction of Labor in Women With Previous Cesarean Section and Premature Rupture of Membranes Who Desire TOLAC: A Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
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:
BILROM-TOLAC
Brief Summary:
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: