Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504465
Status:
COMPLETED
Last Update Posted:
2007-07-20
First Post:
2007-07-19
Brief Title:
Combined Agent Randomized Trial of Induction of Labor
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Cervical Ripening and Induction of Labor a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin
Status:
COMPLETED
Status Verified Date:
2007-07
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:
None
Brief Summary:
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens Our aim was to confirm findings from smaller trials and add to data on fetal safety
Detailed Description:
This study is a non-blinded three arm randomized trial at 3 sites Entry criteria were 36 weeks singleton cephalic gestation with intact membranes and an unripe cervix Bishops score 6 Study arms were 1 dinoprostone vaginal insert Cervidil for 12 hours followed by oxytocin 2 dinoprostone vaginal insert Cervidil for 12 hours with simultaneous oxytocin and 3 intracervical dinoprostone gel Prepidilone dose followed by immediate oxytocin Primary outcome measure was the rate of vaginal delivery 24 hours Secondary outcomes were randomization to delivery interval rate of cesarean delivery CD for non reassuring fetal status NRFS and rate of uterine hyperstimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None