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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-25

Study Completion Date

2019-04-04

Brief Summary

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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

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Detailed Description

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Conditions

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Induction of Labor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propess insertion

Group Type EXPERIMENTAL

Propess insertion group

Intervention Type DRUG

Interventions

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Propess insertion group

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No