Induction of Labor in Oligohydramnios

NCT ID: NCT00815542

Last Updated: 2012-03-23

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-06-30

Brief Summary

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When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.

The study will be a prospective randomised trial.

Detailed Description

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Conditions

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Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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double balloon catheter

Cervical ripening by double balloon catheter

Group Type ACTIVE_COMPARATOR

double balloon catheter

Intervention Type DEVICE

cervical ripening using double balloon catheter

prostaglandins E2

cervical ripening using prostaglandins E2

Group Type PLACEBO_COMPARATOR

prostaglandins E2

Intervention Type DRUG

prostaglandins E2 - Intravaginal Propess for 24 hours

Interventions

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double balloon catheter

cervical ripening using double balloon catheter

Intervention Type DEVICE

prostaglandins E2

prostaglandins E2 - Intravaginal Propess for 24 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* normal pregnancy, well dated, at term
* un ripened cervix

Exclusion Criteria

* previous cesarean section
* multiple pregnancy
* intra uterine growth restricted fetus
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tal Biron - Shental, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University

Locations

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Meir Medial Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Tal Biron - Shental, MD

Role: CONTACT

972-577-482716

Other Identifiers

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034-2011-MMC

Identifier Type: -

Identifier Source: org_study_id

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