Vaginal Misoprostol and Foley Catheter for Induction of Labor

Phase 2

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Misoprostol; Device: Foley Catheter

• Registration Number: NCT02952807
• Lead Sponsor: Zagazig University

Brief Summary

to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

Detailed Description

two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-31
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

Exclusion Criteria

• Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sequential	Foley Catheter	sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.
Concurrent	Foley Catheter	Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.
Concurrent	Misoprostol	Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.
sequential	Misoprostol	sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.

Primary Outcome Measures

Name	Time	Method
induction delivery interval (time from starting induction to delivery)	48hours	safety issue

Secondary Outcome Measures

Name	Time	Method
Cesarean section	72h	safety issue
Severe neonatal morbidity or perinatal death	28 days	safety issue
Need of oxytocin for augmentation of labour	48h	safety issue
Number of doses needed to bring on labour	48h	safety issue
Hyperstimulation syndrome	24h	safety issue
Serious maternal morbidity or maternal death	42 days	safety issue
Failed induction (failure to elicit contraction after 72 hours)	72h	safety issue

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt