Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term

NCT ID: NCT02618096

Last Updated: 2020-03-04

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

2015-10-31

Study Completion Date

2018-10-31

Brief Summary

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The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.

Detailed Description

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Conditions

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Failed Induction of Labor

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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Oxytocin & Membrane sweeping

Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Membrane sweeping

Intervention Type PROCEDURE

Oxytocin & Dinoprostone

Women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Dinoprostone

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Dinoprostone

Intervention Type DRUG

Membrane sweeping

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* Multiparous women
* gestational age \>=37.0 weeks
* Bishop score \<=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria

* Multiple pregnancy
* Placenta previa
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 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

Other Identifiers

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SWP_PG_M2

Identifier Type: -

Identifier Source: org_study_id

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