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

Failed Induction of Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317862
• Other study ID #: FCB_PG_01
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: December 8, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• 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 prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Device:
• Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert

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 fist day of induction	No
Secondary	Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins	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	When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin	Yes