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

Failed Induction of Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596296
• Other study ID #: FCB_PG_parous women
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Device:
• Transcervical foley catheter
16 French foley catheter insertion

Drug:
• Dinoprostone 10mg
Dinoprostone vaginal insertion

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful labor induction	Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm.	Twelve hours of initiating oxytocin on the first day of induction
Secondary	Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion	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	When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin