NCT03682718

Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DEVICE	Transcervical Foley catheter	combined methods of induction of labor Floey Catheter with misoprstol
DRUG	Misoprostol	Misoprstol inserted vaginally for induction of labor

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2018-09-25
• Last updated: 2021-01-20

Locations

1 site across 1 country: Egypt