Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000679886
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
25/06/2012
Date last updated
25/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
In pregnant women how accurate are haemoglobin levels, when measured by two devices Pronto 7 Pulse CO-Oximeter 'Registered Trademark' and Hemocue 'Registered Trademark', compared to the laboratory
Scientific title
In Pregnant women, agreement between haemoglobin measured by three techniques: the laboratory, non-invasive spectrophotometry (Pronto 7 Pulse CO- Oximeter, Masimo Corp, Irvine USA) & invasive photometry absorbance (HemoCue, Angelholm, Sweden), a method comparison study.
Secondary ID [1] 280720 0
Nil
Universal Trial Number (UTN)
U1111-1132-0178
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemoglobin measurement 286764 0
Pregnancy 286777 0
Condition category
Condition code
Reproductive Health and Childbirth 287068 287068 0 0
Normal pregnancy
Blood 287086 287086 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of haemoglobin concentration in pregnant women assessed for each women at a single time point between 20 weeks gestation and the immediate postpartum period.
In each women three measurement techniques will be used (i) automated laboratory, (ii) non-invasive spectrophotometry (Pronto 7 Pulse CO- Oximeter, Masimo Corp, Irvine USA) & (iii) invasive photometry absorbance (HemoCue, Angelholm, Sweden).
Techniques (i) & (iii) will use a venous blood sample, whilst (ii) uses a transcutaneous probe placed on the patients finger.
Intervention code [1] 285140 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287397 0
Agreement (precision, fixed and proportional bias)
Timepoint [1] 287397 0
at single point in time in women between 20 weeks gestation and 5 days post-partum.
Secondary outcome [1] 298057 0
Nil
Timepoint [1] 298057 0
Nil

Eligibility
Key inclusion criteria
Greater than 20 weeks gestation
Having routine Full Blood examination
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5416 0
3084

Funding & Sponsors
Funding source category [1] 285495 0
Hospital
Name [1] 285495 0
Anaesthetic Department, Mercy Hospital For Women
Country [1] 285495 0
Australia
Primary sponsor type
Individual
Name
Dr Richard Hiscock
Address
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Country
Australia
Secondary sponsor category [1] 284340 0
Individual
Name [1] 284340 0
Dr Scott Simmons
Address [1] 284340 0
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Country [1] 284340 0
Australia
Other collaborator category [1] 276877 0
Individual
Name [1] 276877 0
Dr Grace Seow
Address [1] 276877 0
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Country [1] 276877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287517 0
Mercy Hospital For women
Ethics committee address [1] 287517 0
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Ethics committee country [1] 287517 0
Australia
Date submitted for ethics approval [1] 287517 0
06/11/2011
Approval date [1] 287517 0
06/12/2011
Ethics approval number [1] 287517 0
R11/66

Summary
Brief summary
This study aims to assess the agreement between the laboratory measurement of blood haemoglobin and that obtained from two devices which measure haemoglobin at the patients bedside thus providing rapid results which can be used to guide management. One is the HemoCue 'Registered Trademark' device measures Hb concentration from very small amounts of blood either from a finger prick or the veins, the other is the Masimo Pronto-7 'Registered Trademark' spectrophotometry device measures Hb concentration non-invasively using light sensors on a finger probe similar to those used to measure the amount of oxygen in the blood.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34352 0
Address 34352 0
Country 34352 0
Phone 34352 0
Fax 34352 0
Email 34352 0
Contact person for public queries
Name 17599 0
Richard Hiscock
Address 17599 0
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Country 17599 0
Australia
Phone 17599 0
+61 3 84584113
Fax 17599 0
Email 17599 0
[email protected]
Contact person for scientific queries
Name 8527 0
Richard Hiscock
Address 8527 0
Mercy Hospital For Women
163 Studley Road
Heidelberg Vic 3084
Country 8527 0
Australia
Phone 8527 0
+61 3 84584113
Fax 8527 0
Email 8527 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.