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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01317862
First received: March 15, 2011
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Failed Induction of Labor
Device: Transcervical foley catheter, Prostaglandins

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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Successful labor induction [ Time Frame: Twelve hours of initiating oxytocin on the fist day of induction ] [ Designated as safety issue: No ]
    Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    1. Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin)
    2. Incidence of cesarean delivery
    3. Vaginal delivery with 24 hours of starting of induction
    4. The interval from start of oxytocin to delivery
    5. Incidence of admission to neonatal intensive care unit and uterine tachysystole
    6. Pain score by the type of ripening method


Enrollment: 154
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transcervical foley catheter Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert
Active Comparator: Prostaglandins Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317862

Locations
Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01317862     History of Changes
Other Study ID Numbers: FCB_PG_01
Study First Received: March 15, 2011
Last Updated: December 8, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
labor induction, transcervical foley catheter, prostaglandin

ClinicalTrials.gov processed this record on April 14, 2014