Status:
COMPLETED
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Lead Sponsor:
Bloom Technologies
Conditions:
Fetal Monitoring
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks ...
Detailed Description
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study...
Eligibility Criteria
Inclusion
- Pregnant woman ≥ 18 years old
- Gestational age ≥ 32 weeks and 0 days
- Singleton pregnancy
- Ability to read and understand English or Spanish
- Willingness to participate in the study
Exclusion
- Implanted pacemaker or any other implanted electrical device
- Plurality higher than 1
- History of allergies to skin adhesives
- Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations
- Contraindication to the use of CTG
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04915131
Start Date
April 6 2021
End Date
May 5 2022
Last Update
October 18 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Valley Perinatal Services
Phoenix, Arizona, United States, 85004
2
Ochsner
New Orleans, Louisiana, United States, 70115