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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 currently recruiting participants.
Verified October 2016 by Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596296
First Posted: May 10, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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 previous uterine surgical procedure

Exclusion Criteria:

  • major congenital anomaly
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01596296     History of Changes
Other Study ID Numbers: FCB_PG_parous women
First Submitted: May 9, 2012
First Posted: May 10, 2012
Last Update Posted: October 31, 2017
Last Verified: October 2016

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