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Trial registered on ANZCTR


Registration number
ACTRN12620000219987p
Ethics application status
Submitted, not yet approved
Date submitted
5/01/2020
Date registered
24/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between two measurement methods for total hemoglobin in Malawian pregnant women
Scientific title
A comparison between two measurement methods for total hemoglobin in Malawian pregnant women
Secondary ID [1] 299958 0
None
Universal Trial Number (UTN)
Trial acronym
REVAMP Observe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 315403 0
Condition category
Condition code
Blood 313702 313702 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women presenting to the study clinics with haemoglobin >=10g/dL will be referred for enrolment in this cohort. Participants will be recruited from second trimester of pregnancy until 12 months post partum.
We will use several analysers to measure haemoglobin concentration.
The test analyser is: Non-invasive - Masimo Rad-67
Intervention code [1] 316224 0
Diagnosis / Prognosis
Comparator / control treatment
Haemoglobin analyses via:
1. Gold standards - automated haematology analysers (Sysmex and Beckman Coulter)
2. Point of Care - HemoCue 301+
Control group
Active

Outcomes
Primary outcome [1] 322131 0
Agreement between SpHb (measured non invasively via Masimo Rad-67) and venous Hb (measured by automated analyser using the Sysmex and Beckman Coulter instruments) in
pregnant women.
Timepoint [1] 322131 0
Recruitment (Visit 1, Day 0), 4-week follow-up (Visit 2, Day 28 ± 2 days) and at the pre-delivery follow-up (Visit 4, 36 weeks’ gestation ± 2 days)
Primary outcome [2] 322721 0
Specificity of SpHb (Masimo Rad-67) for a diagnosis of anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [2] 322721 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)
Secondary outcome [1] 377446 0
Sensitivity of SpHb (Masimo Rad-67) for a diagnosis of anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [1] 377446 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)
Secondary outcome [2] 378416 0
Birth weight (as a continuous variable) using infant scales
Timepoint [2] 378416 0
Within 24 hours of birth
Secondary outcome [3] 378418 0
Low birth weight (birth weight <2500g) as a dichotomous variable
Timepoint [3] 378418 0
Within 24 hours of birth
Secondary outcome [4] 378419 0
Gestational-age (based on baseline ultrasound dating of pregnancy) adjusted birth weight
Timepoint [4] 378419 0
<24 hours following birth
Secondary outcome [5] 378420 0
Small for gestational age as a dichotomous variable (<10th centile) based on birthweight measured on scales.
Timepoint [5] 378420 0
<24 hours following birth
Secondary outcome [6] 378421 0
Abortion - pregnancy loss before 28 completed weeks of gestation, as reported by patient or based on clinical records, or as observed by study staff.
Timepoint [6] 378421 0
<28 weeks gestation
Secondary outcome [7] 378422 0
Stillbirth – defined as the birth of a baby showing no signs of life after 28 weeks of gestation (>28 weeks), as reported by patient, based on clinical records, or as observed by study staff..
Timepoint [7] 378422 0
>28 weeks gestation
Secondary outcome [8] 378423 0
Gestation duration based on calculated duration of gestation, using dating at baseline ultrasound examination to date of actual delivery.
Timepoint [8] 378423 0
Delivery visit
Secondary outcome [9] 378424 0
Premature birth – neonate born prior to 37 completed weeks of gestation (including 36weeks and 6 days), based on gestation duration according to date of birth compared with expected data of delivery.
Timepoint [9] 378424 0
Delivery visit
Secondary outcome [10] 378425 0
Severe medical events: shock (systolic blood pressure <90mmHg), need for blood transfusion, ICU admission, or mortality: individually and as a composite outcome, based on direct clinical observation by study staff,
Timepoint [10] 378425 0
From recruitment to 4 weeks post partum
Secondary outcome [11] 378426 0
Severe anaemia requiring blood transfusion as defined by clinical notes
Timepoint [11] 378426 0
From recruitment till 4 weeks post partum
Secondary outcome [12] 378427 0
Maternal iron deficiency (defined by i) ferritin<15mg/L using automated biochemistry analysis
Timepoint [12] 378427 0
4 weeks post recruitment, 36 weeks, at delivery, 4 weeks post partum
Secondary outcome [13] 378428 0
Maternal cognitive function using digit span forward and backward test, and mental rotation tests.
Timepoint [13] 378428 0
4 weeks post intervention (for both IV iron and commencement of oral iron), 4 weeks post partum
Secondary outcome [14] 378429 0
Maternal haemoglobin as measured on venous blood via automated analyser.
Timepoint [14] 378429 0
4 weeks post intervention (for both IV iron and commencement of oral iron), week 36, at delivery, 4 weeks post partum
Secondary outcome [15] 378430 0
Maternal fatigue measured by the Piper Fatigue Scale-12
Timepoint [15] 378430 0
4 weeks post recruitment, 36 weeks gestation, 4 weeks post partum
Secondary outcome [16] 378432 0
Maternal anaemia (Hb<11g/dL) as measured on venous blood via automated analyser.
Timepoint [16] 378432 0
4 weeks post recruitment, 36 weeks, at delivery, 4 weeks post partum
Secondary outcome [17] 378433 0
Incidence of placental malaria at delivery based on placental histologic examination
Timepoint [17] 378433 0
Delivery
Secondary outcome [18] 378434 0
Prevalence of malaria parasitaemia based on blood film microscopy at each scheduled visit
Timepoint [18] 378434 0
4 weeks post recruitment, 36 weeks, at delivery, 4 weeks post partum, 3 months, 6 months, 9 months, 12 months
Secondary outcome [19] 378435 0
Child neurocognitive development (Bayley Scales of infant development, CREDI)
Timepoint [19] 378435 0
Children, 6 and 12 months of age
Secondary outcome [20] 378436 0
Child weight (digital scales)
Timepoint [20] 378436 0
6 weeks, 3 months, 6 months, 9 months, 12 months of age
Secondary outcome [21] 378437 0
Child length (infantometer)
Timepoint [21] 378437 0
6 weeks, 3 months, 6 months, 9 months, 12 months of age
Secondary outcome [22] 378438 0
Child neurocognitive development (Evoked Reponsive Potentials using EEG)
Timepoint [22] 378438 0
6 months of age
Secondary outcome [23] 378439 0
Maternal Post-Partum Depression using the Edinburgh Postpartum Depression Scale and the DASS-21
Timepoint [23] 378439 0
3, 6, 9, 12 months post part
Secondary outcome [24] 378440 0
Unscheduled sick visits - mother, measured by data collected by study team related to unscheduled visits to study and other clinics.
Timepoint [24] 378440 0
From recruitment to 12 months post partum
Secondary outcome [25] 378441 0
Unscheduled sick visits - baby, measured by data collected by study team related to unscheduled visits to study and other clinics.
Timepoint [25] 378441 0
From birth to 12 months of age
Secondary outcome [26] 378442 0
Health systems costs of providing the treatments and follow-up for the intervention and comparator based on measurement of resource use and costing of relevant resources, with direct measurement of health care resource utilisation.
Timepoint [26] 378442 0
Each planned visit that coincides with a pregnancy visit (baseline (second trimester), week 36, delivery), unplanned visits (e.g. during any episode of infection requiring management).
Secondary outcome [27] 379443 0
Sensitivity of SpHb (Masimo Rad-67) for a diagnosis of moderate anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [27] 379443 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)
Secondary outcome [28] 379444 0
Specificity of SpHb (Masimo Rad-67) for a diagnosis of moderate anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [28] 379444 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)
Secondary outcome [29] 379445 0
Sensitivity of SpHb (Masimo Rad-67) for a diagnosis of severe anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [29] 379445 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)
Secondary outcome [30] 379446 0
Specificity of SpHb (Masimo Rad-67) for a diagnosis of severe anaemia (as diagnosed by the gold standard using Sysmex and Beckman Coulter instruments)
Timepoint [30] 379446 0
Across all timepoints (baseline during the second trimester, +4 weeks, week 36 of pregnancy)

Eligibility
Key inclusion criteria
1. Confirmed singleton pregnancy at 13-26 weeks gestation
2. Mild or no anaemia (Hb >=10g/dl)
3. Negative malaria parasitaemia
4. Resident in the study catchment area of Blantyre and Zomba district
5. Plan to deliver at a health facility
6. Written informed consent (including assent if <18 years old)
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any injury and/or deformity that interferes with the placement of Masimo sensors or sensor performance.
2. Any nail polish, tattoo, birthmark, etc. that interferes with sensor performance.
3. Finger size does not fit the sensor, as measured by the sensor digit gauge.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
SpHb is currently not intended to be used as a diagnostic parameter for clinical decisions. SpHb data, collected from the main study phase, will be analysed to characterize the agreement between two measurement methods [(1) SpHb and automated analyser (reference devices); and (2) Hemocue and lab analyser] which will characterize the bias and the limits of agreement. Additionally, a threshold analysis will be performed which will exclude the data points that fall into a “Grey Zone.” The “Grey Zone” is an indeterminate zone in the measurement range that will be present due to the imprecision in the device. The thresholds and the “Grey Zone” will be quantified in the calibration phase.
Secondly, we will define the diagnostic test accuracy of the SpHb against venous Hb for diagnosis of i) overall anaemia, ii) moderate anaemia (Hb<10g/dL), and iii) severe anaemia (Hb<7g/dL). SpHb measurements that fall into the “Grey Zone” shall be confirmed with invasive blood measurements for clinical decisions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22155 0
Malawi
State/province [1] 22155 0
Zomba

Funding & Sponsors
Funding source category [1] 304421 0
Charities/Societies/Foundations
Name [1] 304421 0
Bill and Melinda Gates Foundation
Address [1] 304421 0
PO Box 23350
Seattle, WA 98102
Country [1] 304421 0
United States of America
Primary sponsor type
University
Name
University of Malawi, College of Medicine
Address
College of Medicine,
Private Bag 360,
Chichiri,
Blantyre 3
Malawi
Country
Malawi
Secondary sponsor category [1] 304678 0
None
Name [1] 304678 0
Address [1] 304678 0
Country [1] 304678 0
Other collaborator category [1] 281079 0
University
Name [1] 281079 0
Walter and Eliza Hall Institute of Medical Research
Address [1] 281079 0
1G Royal Parade
Parkville VIC 3052
Country [1] 281079 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304856 0
College of Medicine Research and Ethics Committee COMREC
Ethics committee address [1] 304856 0
COMREC
College of Medicine
3rd Floor, John Chiphangwi Learning Resource Centre
Private Bag 360
Chichiri
Blantyre 3
Malawi
Ethics committee country [1] 304856 0
Malawi
Date submitted for ethics approval [1] 304856 0
24/05/2019
Approval date [1] 304856 0
Ethics approval number [1] 304856 0
Ethics committee name [2] 304859 0
The Walter and Eliza Hall Institute of Medical Research Human Research Ethics Committee
Ethics committee address [2] 304859 0
1G Royal Pde
Parkville VIC 3052
Australia
Ethics committee country [2] 304859 0
Australia
Date submitted for ethics approval [2] 304859 0
31/01/2019
Approval date [2] 304859 0
Ethics approval number [2] 304859 0
18/02

Summary
Brief summary
Masimo has developed technology to measure total hemoglobin noninvasively (SpHb). This technology potentially offers promise in the global health context, especially in pregnancy where anemia is highly prevalent and contributes to critical outcomes including maternal mortality and low birth weight. Appropriate evaluation of SpHb in the sub-Saharan African antenatal context could provide opportunities to triage and provide appropriate care to women. This sub-study to the main REVAMP trial will be conducted to evaluate the potential of non-invasive hemoglobin measurements in pregnant women.
This sub-study will recruit additional subjects that are mildly anemic and non-anemic to obtain a broad range of hemoglobin (Hb) concentrations and to examine agreement of these values with the SpHb measurements obtained by the Masimo device. These additional subjects will be the REVAMP-Observe cohort. SpHb will be compared to venous Hb at different time points across the pregnancy. The SpHb value will not be used to make any study decisions or decision regarding the clinical care of the subject.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98422 0
Dr Sant-Rayn Pasricha
Address 98422 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 98422 0
Australia
Phone 98422 0
+61393452618
Fax 98422 0
Email 98422 0
pasricha.s@wehi.edu.au
Contact person for public queries
Name 98423 0
Dr Sant-Rayn Pasricha
Address 98423 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 98423 0
Australia
Phone 98423 0
+61393452618
Fax 98423 0
Email 98423 0
pasricha.s@wehi.edu.au
Contact person for scientific queries
Name 98424 0
Dr Sant-Rayn Pasricha
Address 98424 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 98424 0
Australia
Phone 98424 0
+61393452618
Fax 98424 0
Email 98424 0
pasricha.s@wehi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided. TBD.
What supporting documents are/will be available?
No other documents available
Summary results
No Results