A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

Not Applicable

Completed

• Conditions: Failed Induction of Labor
• Interventions: Device: Transcervical foley catheter, Prostaglandins

• Registration Number: NCT01317862
• 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 prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-08
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• major congenital anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcervical foley catheter	Transcervical foley catheter, Prostaglandins	-
Prostaglandins	Transcervical foley catheter, Prostaglandins	-

Primary Outcome Measures

Name	Time	Method
Successful labor induction	Twelve hours of initiating oxytocin on the fist 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 prostaglandins	When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin	1. Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin); 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; 6. Pain score by the type of ripening method

Trial Locations

Locations (1)

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