Comparison of blood collection tubes for blood glucose testing in the diagnosis of gestational diabetes.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001089628
• Date of registration: 13/10/2014
• Prospective Registration: Yes
• Primary sponsor: Ruth Hughes
• Public title: Comparison of blood collection tubes for blood glucose testing in the diagnosis of gestational diabetes.
• 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.
• Date of first enrolment: 15/12/2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001089628.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Dr Helen Lunt

• Name: Dr Helen Lunt

Key inclusion & exclusion criteria

Inclusion criteria: Pregnant women attending for a routine oral glucose tolerance test to screen for gestational diabetes.
Exclusion criteria: nil

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Public Health - Health service research

gestational diabetes;
gestational diabetes

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

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.

Primary Outcome(s)

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.[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.]

Secondary Outcome(s)

% 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. [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.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

University of Otago Summer Studentship

Secondary Sponsor(s)

Dr Helen Lunt

Ethics review

Status: Approved
Approval date:
Contact:

New Zealand Southern health and disability ethics committee