N/A
N=121
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Fetal Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT04915131 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate — -5.46; -5.57; 6.04; 6.04 BPM
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bloomlife MFM-Pro (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bloom Technologies
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate |
-5.46; -5.57; 6.04; 6.04 | — |
| PRIMARY Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate |
-2.27; -1.84; 3.56; 2.67 | — |
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 of gestation.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04915131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.