NCT01916291

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

August 25, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

March 24, 2020

Status Verified

September 1, 2018

Enrollment Period

5 years

First QC Date

July 29, 2013

Last Update Submit

March 22, 2020

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

  • Induction success rate after propess insertion

    Day 1 after propess insertion

Secondary Outcomes (1)

  • Concentration of prostaglandinE

    at delivery

Study Arms (1)

Propess insertion

EXPERIMENTAL
Drug: Propess insertion group

Interventions

Propess insertion groupDRUG
Propess insertion

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Seoul, 156707, South Korea

Location

Study Officials

  • Joong Shin Park, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 5, 2013

Study Start

August 25, 2013

Primary Completion

August 14, 2018

Study Completion

April 4, 2019

Last Updated

March 24, 2020

Record last verified: 2018-09

Locations

KR(2)