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Trial registered on ANZCTR
Registration number
ACTRN12614001089628
Ethics application status
Approved
Date submitted
30/09/2014
Date registered
13/10/2014
Date last updated
16/06/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of blood collection tubes for blood glucose testing in the diagnosis of gestational diabetes.
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Scientific title
For pregnant women, does blood collection into a citrate test tube, when compared to the standard collection procedure of using a fluoride test tube, produce more accurate venous plasma glucose results.
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Secondary ID [1]
285423
0
Nil known
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Universal Trial Number (UTN)
U1111-1162-3227
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
gestational diabetes
293177
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Condition category
Condition code
Reproductive Health and Childbirth
293453
293453
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0
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Fetal medicine and complications of pregnancy
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Public Health
293454
293454
0
0
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Health service research
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Metabolic and Endocrine
293487
293487
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Interventional study comparing 'new' citrate tubes with conventional fluoride tubes for measuring venous plasma glucose levels during the oral glucose tolerance test in pregnancy. Pregnant women will have blood drawn into three test tubes at each time-point (0-hour, 1-hour, and 2-hour) of their routine oral glucose tolerance test taken between 24-28 weeks' gestation. The usual fluoride tube, the 'new' citrate tube, and a gel tube for the reference glucose.
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Intervention code [1]
290342
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Diagnosis / Prognosis
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Intervention code [2]
290426
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Early detection / Screening
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Comparator / control treatment
Pregnant women will have blood drawn into three test tubes at each time-point of their routine oral glucose tolerance test. The three tubes will include the usual fluoride tube, the 'new' citrate tube, and a gel tube for the reference glucose. Each woman will be her own control.
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Control group
Active
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Outcomes
Primary outcome [1]
293272
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The difference in venous plasma glucose levels measured in mmol/L between the three types of test tube at each time-point (0-hour, 1-hour, and 2-hours) of the oral glucose tolerance test.
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Assessment method [1]
293272
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Timepoint [1]
293272
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At the time of enrolment between 24-28 weeks' gestation, at each time-point (0-hour, 1-hour, and 2-hours) of the oral glucose tolerance test.
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Secondary outcome [1]
310699
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% difference in venous plasma glucose levels measured in the three types of test tube at each time point (0-hour, 1-hour, and 2-hours) of the oral glucose tolerance test.
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Assessment method [1]
310699
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Timepoint [1]
310699
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At the time of enrolment between 24-28 weeks' gestation, at each time-point (0-hour, 1-hour, and 2-hours) of the oral glucose tolerance test.
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Eligibility
Key inclusion criteria
Pregnant women attending for a routine oral glucose tolerance test to screen for gestational diabetes.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
nil
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/11/2014
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Actual
15/12/2014
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Date of last participant enrolment
Anticipated
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Actual
31/05/2015
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Date of last data collection
Anticipated
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Actual
31/05/2015
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Sample size
Target
15
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Accrual to date
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Final
16
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Recruitment outside Australia
Country [1]
6384
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New Zealand
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State/province [1]
6384
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Funding & Sponsors
Funding source category [1]
290027
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University
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Name [1]
290027
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University of Otago Summer Studentship
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Address [1]
290027
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University of Otago Christchurch School of medicine, Christchurch Hospital, Private Bag 4710, Christchurch 8140, Canterbury
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Country [1]
290027
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New Zealand
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Primary sponsor type
Individual
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Name
Ruth Hughes
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Address
Department of Obstetrics and Gynaecology,
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
288719
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Individual
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Name [1]
288719
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Dr Helen Lunt
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Address [1]
288719
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Department of Medicine,
Christchurch Hospital
Private Bag 4710
Christchurch 8140
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Country [1]
288719
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291735
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New Zealand Southern health and disability ethics committee
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Ethics committee address [1]
291735
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Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington
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Ethics committee country [1]
291735
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New Zealand
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Date submitted for ethics approval [1]
291735
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02/10/2014
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Approval date [1]
291735
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16/10/2014
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Ethics approval number [1]
291735
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14/NTA/167
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Summary
Brief summary
This study will see if ‘new’ blood tubes (citrate tubes) are better than the ‘usual’ tubes (fluoride tubes) to test glucose levels. All pregnant women are offered a test for gestational diabetes (GDM) at 24-28 weeks. This is usually with a glucose challenge test (GCT) and / or an oral glucose tolerance test (OGTT). At present, we collect blood samples for these tests into fluoride tubes.
We know that glucose levels may fall in the fluoride tubes in the first hour after the blood is taken. This is important, as there is usually a slight delay between blood collection and laboratory testing of glucose levels. This can result in the measured glucose level being lower than it really is in the body. We might then miss some women with GDM who have a falsely ‘normal’ result. In non-pregnant people, the ‘new’ citrate tubes give results that are more accurate. No one has studied the ‘new’ tubes in pregnancy. We will compare the ‘new’ citrate and ‘usual’ fluoride tubes with a third way of testing glucose that measures the glucose level straight after the blood sample is taken. This third way of testing glucose is the best, but it is not in everyday use as it takes a lot of time to do properly.
We think that the new citrate tubes will be better at detecting GDM than the current system. Missed and untreated cases of GDM can harm the baby. If we show that the ‘new’ citrate tubes are better, then changing to these tubes could mean that we miss fewer women with GDM in the future.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
51798
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Dr Helen Lunt
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Address
51798
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Department of medicine,
Christchurch Hospital,
Private bag 4710,
Christchurch 8140
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Country
51798
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New Zealand
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Phone
51798
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+64 3 3640640
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Fax
51798
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Email
51798
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[email protected]
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Contact person for public queries
Name
51799
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Dr Helen Lunt
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Address
51799
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Department of medicine,
Christchurch Hospital,
Private bag 4710,
Christchurch 8140
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Country
51799
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New Zealand
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Phone
51799
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+64 3 3640640
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Fax
51799
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Email
51799
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[email protected]
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Contact person for scientific queries
Name
51800
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Dr Helen Lunt
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Address
51800
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Department of medicine,
Christchurch Hospital,
Private bag 4710,
Christchurch 8140
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Country
51800
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New Zealand
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Phone
51800
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+64 3 3640640
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Fax
51800
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Email
51800
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[email protected]
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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.
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