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

This study is not yet open for participant recruitment.
Verified May 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01596296
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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 socres 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 2015 (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

  Eligibility

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

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 preiouw uterine surgical procedure

Exclusion Criteria:

  • major congenital anomaly
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596296

Contacts
Contact: Kyo Hoon Park, MD, PhD 82-31-787-7252 pkh0419@snubh.org

Locations
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     pkh0419@snubh.org    
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: NCT01596296     History of Changes
Other Study ID Numbers: FCB_PG_parous women
Study First Received: May 9, 2012
Last Updated: May 9, 2012
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Reproductive Control Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013