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

February 29, 2020 updated by: Kyo Hoon Park, MD, Seoul National University Hospital
To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • Nulliparous 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Oxytocin
Procedure: Membrane sweeping
Active Comparator: Oxytocin & Dinoprostone
For 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
Drug: Oxytocin
Drug: Dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal delivery within 24 hours
Time Frame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.
From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful labor induction
Time Frame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours
to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm
From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours
Incidence of cesarean delivery
Time Frame: End of labor induction (assessed up to 120 hours)
From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of cesarean delivery, assessed up to 120 hours
End of labor induction (assessed up to 120 hours)
The interval from start of oxytocin to delivery
Time Frame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kyo Hoon Park, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 29, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWP_PG_N2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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