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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Information provided by (Responsible Party):
Seoul National University Hospital Identifier:
First received: May 9, 2012
Last updated: May 19, 2015
Last verified: December 2013

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.

Condition Intervention
Failed Induction of Labor
Device: Transcervical foley catheter
Drug: Dinoprostone 10mg

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

Resource links provided by NLM:

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 first 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 dinoprostone vaginal insertion [ Time Frame: When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin ] [ Designated as safety issue: Yes ]
    1. Cervical change based on the bishop score and cervical length induced by cervical ripening methods(foley catheter balloon vs dinoprostone)
    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

Estimated Enrollment: 154
Study Start Date: May 2012
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transcervical foley catheter Device: Transcervical foley catheter
16 French foley catheter insertion
Active Comparator: Dinoprostone Drug: Dinoprostone 10mg
Dinoprostone vaginal insertion


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01596296

Contact: Kyo Hoon Park, MD, PhD 82-31-787-7252

Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Kyo Hoon Park, MD, PhD    82-31-787-7252   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital Identifier: NCT01596296     History of Changes
Other Study ID Numbers: FCB_PG_parous women
Study First Received: May 9, 2012
Last Updated: May 19, 2015
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
labor induction
transcervical foley catheter
parous women

Additional relevant MeSH terms:
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on October 08, 2015