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A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction

NCT ID: NCT02486679

Last Updated: 2016-04-29

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-07-31

Brief Summary

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A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.

Detailed Description

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Conditions

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Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PGE2

Patients allocated to vaginal PGE2 (Prostin) for cervical ripening

Group Type ACTIVE_COMPARATOR

Prostin (PGE2) tablets

Intervention Type DRUG

Foley catheter

Patients allocated to foley catheter placement for cervical ripening

Group Type ACTIVE_COMPARATOR

Foley catheter

Intervention Type DEVICE

Interventions

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Prostin (PGE2) tablets

Intervention Type DRUG

Foley catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Singleton term pregnancies (\>37 weeks), vertex presentation
* Intact membranes
* Low Bishop score (\<7)
* First, second or third delivery
* Medical indication for induction
* Viable fetus

Exclusion Criteria

* Contraindication for vaginal delivery, for PGE2 or foley catheter
* Gestational age\<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hadas Ganer Herman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Ganer Herman, MD

Role: CONTACT

Phone: 972526206696

Email: [email protected]

Facility Contacts

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Hadas Ganer Herman, MD

Role: primary

Other Identifiers

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0095-15-WOMC

Identifier Type: -

Identifier Source: org_study_id