CompletedNot Applicable

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

United States121 participantsStarted 2021-04-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate

Timeframe: 5 minutes

Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate

Timeframe: 5 minutes

Trial details

NCT IDNCT04915131

SponsorBloom Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-28

Results submitted2023-08-16

View on ClinicalTrials.gov More Fetal Monitoring trials