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Study to Determine if Monitoring of Labor Shortens the Time to Delivery (BirthTrack)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005667
Recruitment Status : Withdrawn (Lack of funding for the company has resulted in termination of the study.)
First Posted : November 1, 2009
Last Update Posted : June 23, 2011
Information provided by:
Barnev, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: BirthTrack Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Labor Using the BirthTrack Computerized Labor Monitoring System

Arm Intervention/treatment
Experimental: BirthTrack Monitor Device: BirthTrack
Measurement of cervical dilation and head station
Other Name: Computerized Labor Monitoring System

No Intervention: Control - no BirthTrack Monitor

Primary Outcome Measures :
  1. Shortened time to vaginal delivery [ Time Frame: Length of labor until delivery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005667

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Barnev, Inc.
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Principal Investigator: Barak M Rosenn, MD St. Luke's-Roosevelt Hospital Center
Principal Investigator: Dan Farine, MD MOUNT SINAI HOSPITAL

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Responsible Party: John Quigley, Barnev, Inc. Identifier: NCT01005667    
Other Study ID Numbers: BBT1600
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: October 2009
Keywords provided by Barnev, Inc.:
Nulliparous women in spontaneous labor