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
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01596296
First received: May 9, 2012
Last updated: December 8, 2013
Last verified: December 2013

May 9, 2012
December 8, 2013
May 2012
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01596296 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Failed Induction of Labor
  • Device: Transcervical foley catheter
    16 French foley catheter insertion
  • Drug: Dinoprostone 10mg
    Dinoprostone vaginal insertion
  • Active Comparator: Transcervical foley catheter
    Intervention: Device: Transcervical foley catheter
  • Active Comparator: Dinoprostone
    Intervention: Drug: Dinoprostone 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
Not Provided
April 2015   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Kyo Hoon Park, MD, PhD 82-31-787-7252 pkh0419@snubh.org
Korea, Republic of
 
NCT01596296
FCB_PG_parous women
No
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP