Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Obstetric Complication, Uterine Contractions
Conditions
Keywords
Fetal Heart Rate, Uterine Activity, TrueLabor, OB Tools, Non invasive monitoring
Brief summary
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
Interventions
DEVICETrueLabor
Non invasive monitoring device
Sponsors
OB-Tools Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who are on \>=37w0d of gestation * Maternal age \> 18 years old * Singleton pregnancy * Cephalic presentation * Patient requiring internal monitoring for obstetric indications * Informed consent
Exclusion criteria
* Major fetal anomalies * Patients with implanted electronic devices of any kind * Patients using exterior electronic devices of any kind during the procedure * Patients with irritated skin or open wound on the abdominal wall
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate | Through labor, until delivery | This will be performed using a Performance Goal |
| Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity | Through labor, until delivery | This will be performed using a Performance Goal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2) | Through labor, until delivery | Effect of BMI on the performance measures |
Countries
Israel, United States
Outcome results
None listed