N/A Completed N=121 Other

A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring

Fetal Monitoring

Source: ClinicalTrials.gov NCT04915131 ↗

Enrolled (actual)

121

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcomePrimary: Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate — -5.46; -5.57; 6.04; 6.04 BPM

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.