Vaginal Misoprostol and Foley Catheter for Induction of Labor

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952807
• Other study ID #: 2
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2016
• Last updated: June 14, 2017
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: November 2016
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• Misoprostol
vaginal Misoprostol Plus Foley Catheter

Device:
• Foley Catheter

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction delivery interval (time from starting induction to delivery)	safety issue	48hours
Secondary	Need of oxytocin for augmentation of labour	safety issue	48h
Secondary	Number of doses needed to bring on labour	safety issue	48h
Secondary	Failed induction (failure to elicit contraction after 72 hours)	safety issue	72h
Secondary	Hyperstimulation syndrome	safety issue	24h
Secondary	Cesarean section	safety issue	72h
Secondary	Severe neonatal morbidity or perinatal death	safety issue	28 days
Secondary	Serious maternal morbidity or maternal death	safety issue	42 days