Safety and Efficacy of Dinoprostone (Propess) in the Wome... | NCT01916291

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

NCT01916291

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 24, 2020Actual

Enrollment

189Actual

Phase

Phase 2

Conditions

Induction of Labor

Interventions

Propess insertion group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2013Actual

Primary Completion Date

Aug 14, 2018Actual

Completion Date

Apr 4, 2019Actual

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Aug 1, 2013

First Posted Date

Aug 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2020

Last Update Posted Date

Mar 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Label	Type	Description	Intervention Names
Propess insertion	Experimental		Drug: Propess insertion group

Name	Type	Description	Arm Group Labels	Other Names
Propess insertion group	Drug		Propess insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Induction success rate after propess insertion		Day 1 after propess insertion

Secondary Outcomes

Measure	Description	Time Frame
Concentration of prostaglandinE		at delivery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joong Shin Park, MD PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110744	South Korea
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center