Study to Determine if Monitoring of Labor Shortens the Time to Delivery
Not Applicable
Withdrawn
- Conditions
- Pregnancy
- Interventions
- Device: BirthTrack
- Registration Number
- NCT01005667
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 600
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BirthTrack Monitor BirthTrack -
- Primary Outcome Measures
Name Time Method Shortened time to vaginal delivery Length of labor until delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada