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NCT04232215

Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use

Completed NA Results posted Last updated 20 March 2023
What this trial tests

NA trial testing HeraBEAT™ in Pregnancy Related in 59 participants. Completed in 31 August 2022.

Timeline
3 February 2021
Primary endpoint
28 February 2022
31 August 2022

Quick facts

Lead sponsorMayo Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposediagnostic
Enrollment59
Start date3 February 2021
Primary completion28 February 2022
Estimated completion31 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Device Ease of Use Primary · 8 weeks

Measured using the self-reported System Usability Scale (SUS) on 10 items, each on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree). A composite score is calculated with a range of 0-100 where higher values indicated a high usability of device, whereas lower scores indicate less usability of the device.

GroupValue95% CI
HeraBEAT™ Intervention Group72.8± 19.1
Standard Fetal Doppler Group75.1± 22.5
Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm Primary · 8 weeks

Number of patients to detect a fetal heart rate accurately using the device. An inaccurate assessment is considered any value less than 110 or greater than 160 bpm. A patient with at least one inaccurate value is counted as an event of interest. Patients without an inaccurate event will be counted as a success.

GroupValue95% CI
HeraBEAT™ Intervention Group40
Standard Fetal Doppler Group42

Sponsor's own description

Researchers are assessing the ease of use and accuracy of the HeraBEAT™ device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pregnancy Related

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04232215.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing