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

Barnev

Status

Withdrawn

Conditions

Pregnancy

Treatments

Device: BirthTrack

Study type

Interventional

Funder types

Industry

Identifiers

NCT01005667

BBT1600

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)