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

NCT ID: NCT01317862

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Failed Induction of Labor

Keywords

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labor induction, transcervical foley catheter, prostaglandin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcervical foley catheter

Group Type ACTIVE_COMPARATOR

Transcervical foley catheter, Prostaglandins

Intervention Type DEVICE

16 French foley catheter 10mg dinoprostone vaginal insert

Prostaglandins

Group Type ACTIVE_COMPARATOR

Transcervical foley catheter, Prostaglandins

Intervention Type DEVICE

16 French foley catheter 10mg dinoprostone vaginal insert

Interventions

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Transcervical foley catheter, Prostaglandins

16 French foley catheter 10mg dinoprostone vaginal insert

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyo Hoon Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Other Identifiers

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FCB_PG_01

Identifier Type: -

Identifier Source: org_study_id