Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT03682718
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy
Status:
COMPLETED
Status Verified Date:
2021-01
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:
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
Detailed Description:
Cervical status is a good predictor of the likelihood of vaginal delivery when labor is induced. Any induction method is likely to be effective in a woman with a favorable cervix, whereas no method is highly successful when performed in a woman with a cervix that is unfavorable.
The use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion.
Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms.
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
The use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion.
Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms.
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
Study Oversight
Has Oversight DMC:
True
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?: