Study to Determine if Monitoring of Labor Shortens the Time to Delivery

NCT ID: NCT01005667

Last Updated: 2011-06-23

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

WITHDRAWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.

Detailed Description

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Conditions

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Pregnancy

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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BirthTrack Monitor

Group Type EXPERIMENTAL

BirthTrack

Intervention Type DEVICE

Measurement of cervical dilation and head station

Control - no BirthTrack Monitor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BirthTrack

Measurement of cervical dilation and head station

Intervention Type DEVICE

Other Intervention Names

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Computerized Labor Monitoring System

Eligibility Criteria

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Inclusion Criteria

* The patient must be ≥ 18 years old
* Nulliparous
* Singleton fetus in vertex presentation
* Gestational age 36-0/7 or more
* Reassuring fetal heart tracing

Exclusion Criteria

* Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
* Low lying placenta (edge 3cm or less from cervix)
* Known or suspected fetal or maternal infection
* Maternal thrombocytopenia (platelet count \<100,000)
* Maternal bleeding disorder
* Women with previous uterine surgery
* Known major fetal malformation
* Suspected fetal growth restriction (EFW\<10th percentile)
* Subjects with significant psychiatric history
* Major maternal morbidity (e.g. major cardiac disease)
* Subjects with indication for immediate delivery
* Limit on cervical dilation (e.g., up to 7 cm.)
* Prolonged rupture of membranes (i.e., \> 24 hours)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Barnev, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Barnev, Inc.

Principal Investigators

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Barak M Rosenn, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Dan Farine, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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BBT1600

Identifier Type: -

Identifier Source: org_study_id

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