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NCT05060172: NST
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
NA trial testing Bloomlife MFM-Pro in Fetal Monitoring in 96 participants. Completed in 25 November 2021.
9 November 2021
Quick facts
| Lead sponsor | Bloom Technologies |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 96 |
| Start date | 25 June 2021 |
| Primary completion | 9 November 2021 |
| Estimated completion | 25 November 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Bloomlife MFM-Pro
Conditions studied
- Fetal Monitoring — all drugs for Fetal Monitoring →
Sponsor
Bloom Technologies
Who can join
18 and older, female only, with Fetal Monitoring. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional. Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.
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:
- PubMed search for NCT05060172
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bloomlife MFM-Pro
Trials testing the same drug.
- NCT04915131 — A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepar · NA · completed
Other recruiting trials for Fetal Monitoring
Currently open trials in the same condition.
- NCT06893510 — Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia · NA · recruiting
Other Bloom Technologies trials
Trials by the same sponsor.
- NCT05498298 — A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopo · NA · completed
- NCT05665400 — A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring · NA · completed
- NCT04915131 — A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepar · NA · completed
- NCT03982654 — Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sens · NA · completed
- NCT03969433 — Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05060172 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bloom Technologies
- Last refreshed: 25 January 2022
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/NCT05060172.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing