WithdrawnNCT01005667BirthTrackUpdated Jun 23, 2011

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

An interventional study of BirthTrack in Pregnancy, sponsored by Barnev, Inc.. Withdrawn at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Barnev, Inc. · Not applicable, Interventional, and Treatment

Why this study was withdrawn

Lack of funding for the company has resulted in termination of the study.

Phase: Not applicable
Study type: Interventional
Enrollment: 600
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

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.

Conditions studied

Pregnancy

Keywords

Nulliparous women in spontaneous labor

In context

Lead sponsor

This is the only study on the registry with Barnev, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 600 participants (estimated)

Study arms

Experimental
BirthTrack Monitor
Device: BirthTrack
No intervention
Control - no BirthTrack Monitor

Interventions

DeviceBirthTrack
Measurement of cervical dilation and head station
Also known as: Computerized Labor Monitoring System

What researchers measure

Primary outcomes

Shortened time to vaginal delivery
Time frame: Length of labor until delivery

Study locations

1 site

Mount Sinai Hospital
Toronto, Ontario M5G 1X5, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01005667
Lead sponsor: Barnev, Inc.
First posted: Nov 1, 2009
Last update: Jun 23, 2011

Study contacts

Barak M Rosenn, MD

principal investigator · St. Luke's-Roosevelt Hospital Center

Dan Farine, MD

principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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