Skip to main content
OpenTrials
Completed

NCT Number: NCT01317862

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Failed Induction of Labor

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcervical foley catheter, Prostaglandins

Device

16 French foley catheter 10mg dinoprostone vaginal insert

Primary outcomes

  1. Successful labor induction

    Time frame: 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 outcomes

  1. Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins

    Time frame: When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin

    • Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin)
    • Incidence of cesarean delivery
    • Vaginal delivery with 24 hours of starting of induction
    • The interval from start of oxytocin to delivery
    • Incidence of admission to neonatal intensive care unit and uterine tachysystole
    • Pain score by the type of ripening method

Interested in participating?

Completed

Looking for future studies?

Notify Me

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2011
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.