NCT05656352View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

900

Participants

Timeline

Start Date

September 22, 2022

Primary Completion Date

January 24, 2024

Study Completion Date

January 24, 2024

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.

Trial Locations (4)

Unknown

Kenya Medical Research Institute-Center for Global Health Research, Kisumu

Aga Khan University, Karachi

Kamwala District Health Centre, Lusaka

Women and Newborn Hospital of the University Teaching Hospitals, Lusaka

All Listed Sponsors
lead

George Washington University

OTHER