NCT01317862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1.7 years

First QC Date

March 15, 2011

Last Update Submit

December 8, 2013

Conditions

Failed Induction of Labor

Keywords

labor induction, transcervical foley catheter, prostaglandin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Transcervical foley catheter

ACTIVE COMPARATOR
Device: Transcervical foley catheter, Prostaglandins

Prostaglandins

ACTIVE COMPARATOR
Device: Transcervical foley catheter, Prostaglandins

Interventions

Transcervical foley catheter, ProstaglandinsDEVICE

16 French foley catheter 10mg dinoprostone vaginal insert

ProstaglandinsTranscervical foley catheter

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

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

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Study Officials

  • Kyo Hoon Park, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 17, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

KR(1)