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Pregnancy, High RiskNCT05656352

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

An observational study of Pregnancy, High Risk, run by George Washington University at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, High Risk
What is being tested?
Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device and Complete Blood Count
Type of treatment
Medical device
How many people
900 participants
Where
4 sitesin 3 countries
Study dates
22 Sep 2022to 24 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Pregnant participants from the PRiSMA study

Inclusion Criteria: Any participant that is eligible for the PRiSMA parent study is also considered eligible for this study. Inclusion criteria for the PRiSMA study is as follows:

  1. Lives within the study catchment area;
  2. 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;
  1. Intrauterine pregnancy <20 weeks gestation verified via ultrasound at enrollment;
  2. Provides informed consent.

Exclusion Criteria: Research staff may exclude women from the substudy based on the presence of injury, deformity, tattoo, or birthmark that interferes with Masimo sensor placement or performance or a finger size that does not appropriately fit the device.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Zambia2 sites

  • Kamwala District Health Centre

    Lusaka

  • Women and Newborn Hospital of the University Teaching Hospitals

    Lusaka

Other trials in Zambia

Kenya1 site

  • Kenya Medical Research Institute-Center for Global Health Research

    Kisumu

Other trials in Kenya

Pakistan1 site

  • Aga Khan University

    Karachi

Other trials in Pakistan

About this study

Official title: Comparison of Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device With Laboratory Complete Blood Count Measurement Using Venous Sample: A Substudy of the Pregnancy Risk Stratification Innovation and Measurement Alliance Maternal and Newborn Health (PRiSMA MNH) Study

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.

Read the detailed description

Anemia, a condition that affects an estimated 613 million (33%) women of reproductive age worldwide and is classified as a moderate to severe public health problem in many countries, is a secondary outcome in the PRiSMA MNH study. Three current PRiSMA MNH study sites conduct non-invasive and continuous hemoglobin monitoring with a Masimo device (Kenya, Pakistan, Zambia). 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 measurement takes under one minute and does not require blood samples or laboratory testing. These characteristics make it a particularly promising medical technology for low-resource areas.

Previous research studies have found that SpHb is able to accurately detect hemoglobin levels in adult patients with a similar degree of bias and standard deviation to point-of-care (PoC) invasive method (e.g., HemoCue device) measurements. However, high variability in bias and in limits of agreements for the Masimo device was found in a study involving pregnant patients.

The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and CBC assessed via 5-part autoanalyzer throughout pregnancy and at six weeks postpartum.

This study is nested in the Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) study. PRISMA MNH is a population-based, open-cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes in five countries in sub-Saharan Africa and Southeast Asia. Three study sites (located in Zambia, Kenya, and Pakistan) will participate and collect hemoglobin data at five time points (<20 weeks, 20 weeks, 28 weeks, 36 weeks gestation, and six weeks postpartum). The investigators will measure hemoglobin using a venous blood sample via auto-analyzer (gold standard) and the non-invasive device. The investigators will assess agreement between Masimo total hemoglobin and complete blood count and on a continuous scale using Intraclass Correlation Coefficient and Bland-Altman Analysis. The second objective is to assess agreement between the two measures on a binary scale using Positive Percentage Agreement and Negative Percentage Agreement, Cohen's Kappa, and McNemar Test. On an ordinal scale, agreement will be measured using Weighted Cohen's Kappa and Harrel's Concordance Index. Lastly, the investigators will assess factors that might affect the accuracy of Masimo total hemoglobin using linear mixed models.

Being tested
Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device, Complete Blood Count
Keywords
Hemoglobin, Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring DeviceDevice

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

  • Complete Blood CountDiagnostic 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.

Study groups in NCT05656352
Study groupRoleWhat they receive
Pakistan CohortNot described
Receives: Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count
Kenya CohortNot described
Receives: Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count
Zambia CohortNot described
Receives: Device: Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device; Diagnostic Test: Complete Blood Count

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: <20 weeks gestational age

  2. 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

    Measured: 18-25 weeks gestational age

  3. 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

    Measured: 26-30 weeks gestational age

  4. 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.

    Measured: 34 weeks gestational age until delivery

  5. 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

    Measured: 6-12 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start22 Sep 2022
  3. Primary completion24 Jan 2024
  4. Study completion24 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05656352
Sponsor's protocol ID
SpHb 2022
Status last verified
Jun 2025
First submitted
2 Nov 2022
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Farooq F, Smith ER, Pan Q, Glass Baumann S, Akelo V, Jehan F, Kasaro M, Nisar I, Ouma G, Vwalika B, Spelke MB, Price JT, Hoodbhoy Z. Comparison of Masimo Total Hemoglobin SpHb(R) 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 Maternal and Newborn Health (PRISMA MNH) study. Gates Open Res. 2024 Feb 5;7:50. doi: 10.12688/gatesopenres.14499.2. eCollection 2023.

    PubMed 37868333

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, High Risk, run by George Washington University at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Zambia, Kenya, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin (<20 weeks gestation) (time frame: <20 weeks gestational age). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05656352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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