Study to Determine if Monitoring of Labor Shortens the Time to Delivery
NCT ID: NCT01005667
Last Updated: 2011-06-23
Study Results
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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WITHDRAWN
NA
600 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BirthTrack Monitor
BirthTrack
Measurement of cervical dilation and head station
Control - no BirthTrack Monitor
No interventions assigned to this group
Interventions
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BirthTrack
Measurement of cervical dilation and head station
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nulliparous
* Singleton fetus in vertex presentation
* Gestational age 36-0/7 or more
* Reassuring fetal heart tracing
Exclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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Barnev, Inc.
INDUSTRY
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
Countries
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Other Identifiers
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BBT1600
Identifier Type: -
Identifier Source: org_study_id
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