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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317862
First Posted: March 17, 2011
Last Update Posted: December 10, 2013
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. 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 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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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): 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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01317862     History of Changes
Other Study ID Numbers: FCB_PG_01
First Submitted: March 15, 2011
First Posted: March 17, 2011
Last Update Posted: December 10, 2013
Last Verified: December 2013

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