Concurrent Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix

March 1, 2020 updated by: Seoul National University Hospital
To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor induction for nulliparas at term with an unfavorable cervix

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

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: Dinoprostone
Drug: 10mg Dinoprostone vaginal insert
For women assigned to "No sweep": The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening
Active Comparator: Concurrent membrane sweeping with Dinoprostone
Procedure: Concurrent membrane sweeping with Dinoprostone
Women assigned to "Sweep" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal delivery within 24 hours
Time Frame: Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction
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.
Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical change in the bishop scores and cervical lengths
Time Frame: Initiation of oxytocin after removing dinoprostone vaginal insert
  1. Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone)
  2. Incidence of cesarean delivery
  3. Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm).
  4. The interval from start of oxytocin to delivery
  5. Incidence of rupture of membranes
  6. Incidences of vaginal bleeding and fever
Initiation of oxytocin after removing dinoprostone vaginal insert

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 Bundang 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

February 1, 2013

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 1, 2020

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWP_PG_Null

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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