Pregnancy
Conditions
Keywords
Nulliparous women in spontaneous labor
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.
Interventions
DEVICEBirthTrack
Measurement of cervical dilation and head station
Sponsors
Barnev, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shortened time to vaginal delivery | Length of labor until delivery |
Countries
Canada
Outcome results
None listed