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
About this trial
This is an interventional treatment trial for Induction of Labor
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
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
NCT ID
NCT01916291
First Posted
July 29, 2013
Last Updated
March 22, 2020
Sponsor
Seoul National University Hospital
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
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