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NCT01005667 Clinical Trial

Study to Determine if Monitoring of Labor Shortens the Time to Delivery

Pregnancy Clinical Trial

— BirthTrack  

Official title:
Management of Labor Using the BirthTrack Computerized Labor Monitoring System

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01005667
Other study ID # BBT1600
Secondary ID
Status Withdrawn
Phase N/A
First received October 30, 2009
Last updated June 22, 2011

Study information
Verified date October 2009
Source Barnev, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• BirthTrack
Measurement of cervical dilation and head station

Locations
Country Name City State
Canada Mount Sinai Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Barnev, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Shortened time to vaginal delivery Length of labor until delivery No
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