- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01005667
Study to Determine if Monitoring of Labor Shortens the Time to Delivery (BirthTrack)
June 22, 2011 updated by: Barnev, Inc.
Management of Labor Using the BirthTrack Computerized Labor Monitoring System
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BirthTrack Monitor
|
Measurement of cervical dilation and head station
Other Names:
|
No Intervention: Control - no BirthTrack Monitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shortened time to vaginal delivery
Time Frame: Length of labor until delivery
|
Length of labor until delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barak M Rosenn, MD, St. Luke's-Roosevelt Hospital Center
- Principal Investigator: Dan Farine, MD, Mount Sinai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 30, 2009
First Submitted That Met QC Criteria
October 30, 2009
First Posted (Estimate)
November 1, 2009
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
October 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- BBT1600
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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