Brief Summary
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
Brief Title
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
Completion Date
Completion Date Type
Actual
Conditions
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor
Uterine Contractions
Obstetric Complication
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Keywords
Fetal Heart Rate
Uterine Activity
TrueLabor
OB Tools
Non invasive monitoring
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05782296
Org Class
Industry
Org Full Name
OB-Tools Ltd.
Org Study Id
CL-00002
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study
Primary Outcomes
Outcome Description
This will be performed using a Performance Goal
Outcome Measure
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
Outcome Time Frame
Through labor, until delivery
Outcome Description
This will be performed using a Performance Goal
Outcome Measure
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
Outcome Time Frame
Through labor, until delivery
Secondary Outcomes
Outcome Description
Effect of BMI on the performance measures
Outcome Time Frame
Through labor, until delivery
Outcome Measure
Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Women (age\>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dimitrios Mastrogiannis
Investigator Email
dmastrogia@montefiore.org