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

This study has been withdrawn prior to enrollment.
(Lack of funding for the company has resulted in termination of the study.)
Sponsor:
Information provided by:
Barnev, Inc.
ClinicalTrials.gov Identifier:
NCT01005667
First received: October 30, 2009
Last updated: June 22, 2011
Last verified: October 2009
  Purpose

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 Intervention
Pregnancy
Device: BirthTrack

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Labor Using the BirthTrack Computerized Labor Monitoring System

Further study details as provided by Barnev, Inc.:

Primary Outcome Measures:
  • Shortened time to vaginal delivery [ Time Frame: Length of labor until delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Arms Assigned Interventions
Experimental: BirthTrack Monitor Device: BirthTrack
Measurement of cervical dilation and head station
Other Name: Computerized Labor Monitoring System
No Intervention: Control - no BirthTrack Monitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005667

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Barnev, Inc.
Investigators
Principal Investigator: Barak M Rosenn, MD St. Luke's-Roosevelt Hospital Center
Principal Investigator: Dan Farine, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: John Quigley, Barnev, Inc.
ClinicalTrials.gov Identifier: NCT01005667     History of Changes
Other Study ID Numbers: BBT1600
Study First Received: October 30, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Barnev, Inc.:
Nulliparous women in spontaneous labor

ClinicalTrials.gov processed this record on August 20, 2014