search
Back to results

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

Primary Purpose

Induction of Labor

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propess insertion group
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction of Labor

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital
  • Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Propess insertion

Arm Description

Outcomes

Primary Outcome Measures

Induction success rate after propess insertion

Secondary Outcome Measures

Concentration of prostaglandinE

Full Information

First Posted
July 29, 2013
Last Updated
March 22, 2020
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01916291
Brief Title
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
Official Title
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 25, 2013 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propess insertion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propess insertion group
Primary Outcome Measure Information:
Title
Induction success rate after propess insertion
Time Frame
Day 1 after propess insertion
Secondary Outcome Measure Information:
Title
Concentration of prostaglandinE
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joong Shin Park, MD PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs