Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000247178
Ethics application status
Approved
Date submitted
11/02/2019
Date registered
19/02/2019
Date last updated
17/03/2022
Date data sharing statement initially provided
19/02/2019
Date results information initially provided
17/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Haemoglobin measurement using three different techniques in women undergoing planned vaginal birth
Scientific title
An agreement study comparing Masimo SpHb co-oximeter (Rad-67™ Pulse CO-Oximeter®) and HemoCue® (Hb 201+ System) with laboratory haemoglobin in women undergoing planned vaginal birth
Secondary ID [1] 297355 0
None
Universal Trial Number (UTN)
U1111-1228-2808
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstetric haemorrhage 311475 0
Condition category
Condition code
Blood 310120 310120 0 0
Anaemia
Reproductive Health and Childbirth 310241 310241 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will have an intravenous cannula (IVC) inserted and a venous blood sample taken as part of their routine management of labour. The timing of the IVC and venous blood sampling will be when the woman requires an IVC during her labour as part of routine management of labour. This blood will be sent to the laboratory for the laboratory haemoglobin measurement and, at the same time as the venous blood is sampled and from that same sample, one drop of blood will be used to obtain the Hemocue® haemoglobin sample measurement. A HemoCue® measurement of haemoglobin will also be taken at the same time via a finger prick (like a blood glucose finger prick test). At the same time blood is taken for laboratory haemoglobin measurement and Hemocue®, the finger probe of the Rad-67 continuous haemoglobin monitor will be applied to the participant finger or thumb on the same arm as the blood is taken from. The Rad-67 device obtains the haemoglobin via the placement of a finger/thumb probe that rests comfortably on a finger/thumb. The first haemoglobin reading from the Rad-67 device will be recorded as the haemoglobin result from that device.
Staff taking blood samples: one of the study investigators will take the blood samples
Timing of blood samples: samples will all be taken at the same time either at the start or during labour when the IVC is inserted - only one sample at one time using each method will be undertaken
Location of blood samples: blood samples will all be taken from the participant's arm or hand, and the location within the hospital will be one of the acute care areas - birthing suite, emergency department, assessment centre - or wherever the participant has an IVC inserted
Intervention code [1] 313604 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319013 0
Laboratory measured haemoglobin value measured in g/dl
Timepoint [1] 319013 0
At the time of insertion of intravenous cannula at the start or during labour
Primary outcome [2] 319126 0
Haemoglobin value measured in g/dl using the Masimo Rad 67 device
Timepoint [2] 319126 0
At the time of insertion of intravenous cannula at the start or during labour
Primary outcome [3] 319143 0
Haemoglobin value measured in g/dl using the HemoCue®
Timepoint [3] 319143 0
At the time of insertion of intravenous cannula at the start or during labour
Secondary outcome [1] 367104 0
The number of women who have a laboratory haemoglobin value of less than 11 g/dl
Timepoint [1] 367104 0
At the time of insertion of intravenous cannula at the start or during labour

Eligibility
Key inclusion criteria
Any women planning on having a vaginal birth including those having planned induction of labour, women who have their labour augmented and women experiencing spontaneous onset of labour.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with:
Abnormal haemoglobin disorders
Hyperbilirubinaemia
Raynaud’s or Peripheral Vascular Disease

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The level of agreement will be assessed between laboratory haemoglobin and Masimo SpHb co-oximeter, and laboratory haemoglobin and HemoCue® (both venous sample and capillary sample) as two separate analyses. Bland Altman methodology will be used. Bias will be calculated as the mean difference between the two measurements, and the limits of agreement will be defined as mean difference plus or minus 1.96 SD of the mean difference.

Sample size:
The sample size was calculated using the method described by Lu et al 2016 using MedCalc Statistical Software version 18.11 (MedCalc Software bvba, Ostend, Belgium; https://www.medcalc.org; 2018). A preliminary study in pregnancy has shown that the mean difference between laboratory haemoglobin measurement and Masimo SpHb co-oximeter is 1.22 g/dl and the standard deviation of the differences is 1.0 g/dl (Carvalho 2012).

Therefore, a minimum sample size of 169 women is required for the Bland-Altman analysis at 80% power and 0.05 two-sided level of significance with an expected mean difference of 1.0 g/dl, standard deviation of differences at 1.5 g/dl, and a predefined clinical agreement limit for the maximum allowed difference between the two methods set at 4.5 g/dl. Acceptable agreement will be defined as a clinical agreement limit of less than or equal to 4.5 g/dl. Marginal agreement will be defined as a clinical agreement limit of 4.6 to 5.0 g/dl, and unacceptable agreement will be defined as a clinical agreement limit of greater than 5.0 g/dl. We will aim to collect data for 180 women to allow for a minimum of 5% missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2019
Actual
30/03/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
29/07/2021
Date of last data collection
Anticipated
31/12/2021
Actual
29/07/2021
Sample size
Target
180
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13082 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 25591 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 301919 0
Hospital
Name [1] 301919 0
Royal Women's Hospital
Country [1] 301919 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Locked Bag 300, Corner Grattan Street and Flemington Road, Parkville, Victoria, Australia 3052
Country
Australia
Secondary sponsor category [1] 301676 0
None
Name [1] 301676 0
Address [1] 301676 0
Country [1] 301676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302604 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302604 0
The Royal Women's Hospital, Locked Bag 300, Corner Grattan Street and Flemington Road, Parkville, Victoria, Australia 3052
Ethics committee country [1] 302604 0
Australia
Date submitted for ethics approval [1] 302604 0
09/01/2019
Approval date [1] 302604 0
20/03/2019
Ethics approval number [1] 302604 0
HREC 19_03

Summary
Brief summary
We aim to compare two bedside haemoglobin (Hb) measurement techniques (Rad-67™ Pulse CO-Oximeter® and HemoCue® with laboratory Hb measurements in women undergoing planned vaginal birth. Each woman will have a blood sample taken to measure Hb as part of routine care as well as a finger prick blood Hb sample (HemoCue®), and a monitor Hb measurement that is attached to the woman's finger (Rad-67™ Pulse CO-Oximeter®). The finger prick and monitor Hb measurements will be compared to the laboratory Hb sample to see if they give the same reading. The purpose of this study is to determine whether a bedside test of Hb is accurate enough to replace laboratory based Hb testing in pregnant women. The hypothesis is that these bedside tests will be able to replace laboratory Hb measurements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90794 0
A/Prof Alicia Dennis
Address 90794 0
The Royal Women's Hospital, Locked Bag 300, Corner Grattan Street and Flemington Road, Parkville, Victoria, Australia 3052
Country 90794 0
Australia
Phone 90794 0
+61 3 8345 2000
Fax 90794 0
+61 3 8345 2371
Email 90794 0
[email protected]
Contact person for public queries
Name 90795 0
A/Prof Alicia Dennis
Address 90795 0
The Royal Women's Hospital, Locked Bag 300, Corner Grattan Street and Flemington Road, Parkville, Victoria, Australia 3052
Country 90795 0
Australia
Phone 90795 0
+61 3 8345 2000
Fax 90795 0
+61 3 8345 2371
Email 90795 0
[email protected]
Contact person for scientific queries
Name 90796 0
A/Prof Alicia Dennis
Address 90796 0
The Royal Women's Hospital, Locked Bag 300, Corner Grattan Street and Flemington Road, Parkville, Victoria, Australia 3052
Country 90796 0
Australia
Phone 90796 0
+61 3 8345 2000
Fax 90796 0
+61 3 8345 2371
Email 90796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Yes we will make the de-identified individual participant data underlying the published results available as a supplemental file with the publication. These data will be available with the publication with no end date and available to any researcher who wishes to access it for their research or clinical purpose.
When will data be available (start and end dates)?
These data will be available with the publication with no end date and available to any researcher who wishes to access it for their research or clinical purpose.
Available to whom?
These data will be available with the publication with no end date and available to any researcher who wishes to access it for their research or clinical purpose.
Available for what types of analyses?
These data will be available with the publication with no end date and available to any researcher who wishes to access it for their research or clinical purpose.
How or where can data be obtained?
These data will be available with the publication (published as an appendix to the publication) with no end date and available to any researcher who wishes to access it for their research or clinical purpose.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4116Plain language summaryNo Basic English summary is presented in the publishe... [More Details]
4755Study results articleYes Caulfield, K.C., McMahon, O. and Dennis, A.T. (202... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of haemoglobin concentration measured using three different techniques in pregnant people undergoing vaginal birth.2023https://dx.doi.org/10.1016/j.ijoa.2023.103672
N.B. These documents automatically identified may not have been verified by the study sponsor.