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

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.

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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
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

Exclusion criteria

major congenital anomaly

Treatment and study plan

Transcervical Foley Catheter

Device

16 French foley catheter insertion

Dinoprostone 10mg

Drug

Dinoprostone vaginal insertion

Primary outcomes

Successful labor induction

Time frame: 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 outcomes

Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion

Time frame: When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin
- Cervical change based on the bishop score and cervical length induced by cervical ripening methods(foley catheter balloon vs dinoprostone)
- 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: May 10, 2012
Registry last updated: Mar 3, 2020

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.

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Completed