Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

March 22, 2020 updated by: Seoul National University Hospital
Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 2

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
      • Seoul, Korea, Republic of, 110744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 156707
        • Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women who admitted for induction of labor
  • Bishop score <= 6

Exclusion Criteria:

  • Contraindication to induction of labor
  • Active labor
  • Vaginal bleeding, unknown origin
  • Hypersensitive to Prostaglandin E
  • History of asthma, glaucoma
  • Infection (birth canal)
  • Placental abruption
  • Multiparity(>5)
  • Pelvic inflammatory disease
  • Heart, lung, kidney disease
  • Multiple pregnancy
  • Major anomaly
  • Fetal distress before induction of labor

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propess insertion
Drug: Propess insertion group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Induction success rate after propess insertion
Time Frame: Day 1 after propess insertion
Day 1 after propess insertion

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of prostaglandinE
Time Frame: at delivery
at delivery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Joong Shin 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 (Actual)

August 25, 2013

Primary Completion (Actual)

August 14, 2018

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 22, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Propess in PROM or GA<38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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