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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001089628
Enrollment
16
Registered
2014-10-13
Start date
2014-12-15
Completion date
2015-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Ruth Hughes
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

Pregnant women attending for a routine oral glucose tolerance test to screen for gestational diabetes.

Exclusion criteria

nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026