Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05656352 |
| Other study ID # |
SpHb 2022 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 22, 2022 |
| Est. completion date |
February 28, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
George Washington University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
