Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial
1 other identifier
interventional
154
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 3, 2020
October 1, 2016
5.4 years
May 9, 2012
March 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful labor induction
Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm.
Twelve hours of initiating oxytocin on the first day of induction
Secondary Outcomes (1)
Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion
When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin
Study Arms (2)
Transcervical foley catheter
ACTIVE COMPARATORDinoprostone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- major congenital anomaly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PMID: 36996264DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyo Hoon Park, MD, PhD
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 10, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 3, 2020
Record last verified: 2016-10