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NCT05656352
Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia
trial testing Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device in Pregnancy, High Risk in 900 participants. Completed in 24 January 2024.
24 January 2024
Quick facts
| Lead sponsor | George Washington University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 900 |
| Start date | 22 September 2022 |
| Primary completion | 24 January 2024 |
| Estimated completion | 24 January 2024 |
| Sites | 4 locations across Pakistan, Kenya, Zambia |
Drugs / interventions tested
- Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device
- Complete Blood Count
Conditions studied
- Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
Sponsor
George Washington University
Who can join
15 and older, female only, with Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Accurate, precise, and comparable hemoglobin measurements is of great importance, both for clinical value in diagnosing anemia and ensuring pregnant women receive appropriate treatment. The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device with an optical sensor placed on the finger that measures hemoglobin levels using pulse oximetry. The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and the gold standard laboratory-based assessment (complete blood count assessed via five-part autoanalyzer) throughout the course of pregnancy and at six weeks postpartum.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison of Masimo Total Hemoglobin SpHb® continuous non-invasive hemoglobin monitoring device with laboratory complete blood count measurement using venous sample: Protocol for an observational substudy of the Pregnancy Risk and Infant Surveillance and Measurement Alliance Mat
Farooq F, Smith ER, Pan Q, Glass Baumann S, et al · · 2023 · cited 2× · PMID 37868333 · DOI 10.12688/gatesopenres.14499.2
Verify or expand the search:
- PubMed search for NCT05656352
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other George Washington University trials
Trials by the same sponsor.
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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 NCT05656352 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by George Washington University
- Last refreshed: 19 June 2025
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/NCT05656352.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing