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

This study is currently recruiting participants.

Verified February 2012 by Seoul National University Hospital

Sponsor:

Information provided by (Responsible Party):

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01317862

First received: March 15, 2011

Last updated: February 7, 2012

Last verified: February 2012

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ 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 prostaglandins [ Time Frame: When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin ] [ Designated as safety issue: Yes ]
1. Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostagladin)
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

Estimated Enrollment:	154
Study Start Date:	January 2011
Estimated Primary Completion Date:	April 2013 (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

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317862

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:	NCT01317862 History of Changes
Other Study ID Numbers:	FCB_PG_01
Study First Received:	March 15, 2011
Last Updated:	February 7, 2012
Health Authority:	Korea: Institutional Review Board Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

labor induction, transcervical foley catheter, prostaglandin

ClinicalTrials.gov processed this record on May 16, 2013

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