- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656352
Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emily R Smith, ScD, MPH
- Phone Number: 2029943589
- Email: emilysmith@gwu.edu
Study Contact Backup
- Name: Fouzia Farooq, PhD, MPH
- Email: fouziafarooq@gwu.edu
Study Locations
-
-
-
Kisumu, Kenya
- Recruiting
- Kenya Medical Research Institute-Center for Global Health Research
-
Contact:
- Gregory Ouma, MD
- Email: GOuma@kemri.go.ke
-
-
-
-
-
Karachi, Pakistan
- Recruiting
- Aga Khan University
-
Contact:
- Zahra Hoodbhoy, MBBS, MEd, PhD
- Email: zahra.hoodbhoy@aku.edu
-
-
-
-
-
Lusaka, Zambia
- Recruiting
- Kamwala District Health Centre
-
Contact:
- Bridget Spelke, MD
- Email: bspelke@email.unc.edu
-
Lusaka, Zambia
- Not yet recruiting
- Women and Newborn Hospital of the University Teaching Hospitals
-
Contact:
- Bridget Spelke, MD
- Email: bspelke@email.unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pakistan Cohort
|
Masimo Radical-67® Pulse CO-Oximeter and rainbow® sensors.
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
|
Masimo Radical-67® Pulse CO-Oximeter and rainbow® sensors.
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.
|
Zambia Cohort
|
Masimo Radical-67® Pulse CO-Oximeter and rainbow® sensors.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin (<20 weeks gestation)
Time Frame: <20 weeks gestational age
|
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)
Time Frame: 18-25 weeks gestational age
|
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)
Time Frame: 26-30 weeks gestational age
|
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)
Time Frame: 34 weeks gestational age until delivery
|
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)
Time Frame: 6-12 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SpHb 2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy, High Risk
-
Yalda Afshar, MD, PhDUniversity of California, Los AngelesRecruiting
-
George Washington UniversityUniversity of North Carolina, Chapel Hill; Aga Khan University; Kenya Medical... and other collaboratorsRecruitingPregnancy, High RiskPakistan, Ghana, Kenya, India, Zambia
-
London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia
-
University of AarhusCopenhagen University Hospital, HvidovreCompletedAn Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.Pregnancy, High RiskDenmark
-
Ain Shams UniversityCompletedHigh Risk PregnancyEgypt
-
University Hospital, LilleCompletedPregnancy, High RiskFrance
-
Istituto Giannina GasliniRecruiting
-
Lo.Li.Pharma s.r.lCompletedPregnancy, High RiskItaly
-
Indiana UniversityCompletedPregnancy, High RiskUnited States
-
Oregon Health and Science UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
Clinical Trials on Masimo Total Hemoglobin SpHb® Continuous Non-invasive Hemoglobin Monitoring Device
-
The Cleveland ClinicAlertgyCompletedType 2 DiabetesUnited States
-
EclypiaRecruiting
-
Bulent Ecevit UniversityCompletedHemorrhage | Bleeding | Hemodynamic InstabilityTurkey
-
University Hospital, LinkoepingCompleted
-
Society for the Advancement of Blood Management...UnknownSurgeryUnited States, France, Italy, Japan
-
The University of Texas Medical Branch, GalvestonCompletedAnemia in PregnancyUnited States
-
St. Justine's HospitalUnknownEvaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive Monitor
-
Northwestern UniversityCompletedPostpartum Hemorrhage | Postsurgical Bleeding | Abdominal Ultrasound | FAST Scan | Non-invasive Hemoglobin MeasurementUnited States
-
University of North Carolina, Chapel HillCompletedHemoglobin ResultsUnited States