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Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia

NCT05656352 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2025-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy, High Risk

Interventions

DEVICE

Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device

Masimo Radical-67® Pulse CO-Oximeter and rainbow® sensors.

DIAGNOSTIC_TEST

Complete Blood Count

The test will be done using venous blood collected in EDTA tubes. Samples will be analyzed within 6 hours of collection or stored at 2 to 8C and analyzed within 24 hours. Analysis will be done using a five-part differential hematology analyzer.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2024-01-24
Completion
2024-01-24
FDA Device
Yes

Countries

  • Kenya
  • Pakistan
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656352 on ClinicalTrials.gov