Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

Not Applicable

Completed

• Conditions: Failed Induction of Labor
• Interventions: Drug: Dinoprostone 10mg; Device: Transcervical foley catheter

• Registration Number: NCT01596296
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and labor induction in term parous women with unfavorable cervix.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• singleton pregnancy
• parous women
• gestational age >=37.0 weeks
• Bishop score <=5
• intact amniotic membrane
• absence of labor
• live fetus with vertex presentation
• no previous uterine surgical procedure

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Exclusion Criteria

• major congenital anomaly

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dinoprostone	Dinoprostone 10mg	-
Transcervical foley catheter	Transcervical foley catheter	-

Primary Outcome Measures

Name	Time	Method
Successful labor induction	Twelve hours of initiating oxytocin on the first day of induction	Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm.

Secondary Outcome Measures

Name	Time	Method
Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion	When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin	1. Cervical change based on the bishop score and cervical length induced by cervical ripening methods(foley catheter balloon vs dinoprostone); 2. Incidence of cesarean delivery; 3. Vaginal delivery with 24 hours of starting of induction; 4. The interval from start of oxytocin to delivery; 5. Incidence of admission to neonatal intensive care unit and uterine tachysystole

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of