Continuous Fetal Monitoring During Vacuum Delivery

NCT ID: NCT00956826

Last Updated: 2009-08-11

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

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.

Detailed Description

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The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. The electrode is a standard one inserted in the vacuum device.

Conditions

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Vacuum Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electrode added to device

With an electrode and a regular vacuum device

Group Type EXPERIMENTAL

Agit Vacuum

Intervention Type DEVICE

With an electrode and a regular vacuum device

Interventions

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Agit Vacuum

With an electrode and a regular vacuum device

Intervention Type DEVICE

Other Intervention Names

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Agit Vaccum

Eligibility Criteria

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Inclusion Criteria

* All fetuses at vacuum delivery

Exclusion Criteria

* None
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah University Hospital

Principal Investigators

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David Mankuta, MD

Role: STUDY_CHAIR

Hadassah

Locations

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Hadassah Ein Kerem

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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David Mankuta, MD

Role: CONTACT

02 6776111

Gal Nasi, BsC

Role: CONTACT

02 6776111

Other Identifiers

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FMV123

Identifier Type: -

Identifier Source: secondary_id

fetal monitoring vaccum

Identifier Type: -

Identifier Source: org_study_id

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