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

NCT05656352 | Completed FDA Device

• 1 other identifier: SpHb 2022
• Study Type: observational
• Target: 900
• Locations: 3 countries
• Sites: 4

Brief 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

Keywords

Hemoglobin; Pregnancy

Outcome Measures

Primary Outcomes (5)

• Hemoglobin (<20 weeks gestation)

  Hemoglobin levels will be assessed using the Masimo device and via complete blood count (5 part autoanalyzer) during pregnancy: \<20 weeks gestation

  <20 weeks gestational age

• Hemoglobin (20 weeks gestation)

  Hemoglobin levels will be assessed using the Masimo device and via complete blood count (5 part autoanalyzer) during pregnancy: 20 weeks

  18-25 weeks gestational age

• Hemoglobin (28 weeks gestation)

  Hemoglobin levels will be assessed using the Masimo device and via complete blood count (5 part autoanalyzer) during pregnancy: 28 weeks

  26-30 weeks gestational age

• Hemoglobin (36 weeks gestation)

  Hemoglobin levels will be assessed using the Masimo device and via complete blood count (5 part autoanalyzer) during pregnancy: 36 weeks.

  34 weeks gestational age until delivery

• Hemoglobin (6 weeks postpartum)

  Hemoglobin levels will be assessed using the Masimo device and via complete blood count (5 part autoanalyzer) at 6 weeks postpartum

  6-12 weeks postpartum

Study Arms (3)

Pakistan Cohort

Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count

Kenya Cohort

Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count

Zambia Cohort

Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count

Interventions

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

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

Kenya Cohort; Pakistan Cohort; Zambia Cohort

Complete Blood Count DIAGNOSTIC_TEST

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.

Kenya Cohort; Pakistan Cohort; Zambia Cohort

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant participants from the PRiSMA study

You may qualify if:

• Lives within the study catchment area;
• Meets minimum age requirement in study site country:
• Kenya: 18 years of age or those who meet the criteria of emancipated minors;
• Pakistan: 15 years of age or those who meet the criteria of emancipated minors;
• Zambia: 15 years of age;
• Intrauterine pregnancy \<20 weeks gestation verified via ultrasound at enrollment;
• Provides informed consent.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (4)

Kenya Medical Research Institute-Center for Global Health Research

Kisumu, Kenya

Location

Aga Khan University

Karachi, Pakistan

Location

Kamwala District Health Centre

Lusaka, Zambia

Location

Women and Newborn Hospital of the University Teaching Hospitals

Lusaka, Zambia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood sample

MeSH Terms

Interventions

Blood Cell Count

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 19, 2022
• Study Start: September 22, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

PA (1); ZA (2); KE (1)