In this study we will assess the optimal analytical conditions for routine laboratory GDM screening in the Netherlands, possible discrepancies in clinical outcome due to (pre)analytical variation and the applicability of POCT testing in GDM…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1) Stability of in vitro glucose levels after phlebotomy under a variety
of (pre)analytical variables, such as the choice of the collection tube and
the optimal turn-around-time. Part 2) the applicability of POCT testing in the
diagnosis of GDM in comparison with phlebotomy and determination of the
possible clinical misdiagnosis of GDM if one deviates from the optimal
(pre)analytical variables.
Secondary outcome
None
Background summary
Pregnancy diabetes is associated with an increased risk of maternal, foetal and
neonatal mortality and morbidity. In order to prevent this, glucose levels
should be regulated as well as possible, both during preconception and
pregnancy. In the Netherlands, approximately 400 pregnant, type I diabetic
women are treated (frequency 0,2%). Similar numbers are found for type II
diabetics. In addition, approximately 3-5% of all pregnant women develop
diabetes gravidarum (GDM), described as diabetes diagnosed during pregnancy.
Although national guidelines do exist, there is no consensus for the laboratory
analysis of glucose as well as for screening and treatment of GDM.
Study objective
In this study we will assess the optimal analytical conditions for routine
laboratory GDM screening in the Netherlands, possible discrepancies in clinical
outcome due to (pre)analytical variation and the applicability of POCT testing
in GDM screening.
Study design
This study consists of 2 consecutive parts. Part 1) blood will be collected
via venapuncture from healthy volunteers to identify the optimal
(pre)analytical conditions for glucose analysis. Blood will be collected in a
variety of collection tubes (sodium-fluoride(NaF)-EDTA, NaF-oxalate, NaF-EDTA
Citrate and lithium-heparin) and compared to recommended procedures. Glucose
levels will be determined after set time points to mimic routine daily
laboratory practice. Part 2) An oral glucose tolerance test GTT (75g) will be
performed in pregnant women. Subjects will be phlebotomized according to the
most optimal protocol (determined in part 1) prior to and 120 minutes after the
start of the GTT and, simultaneously, glucose levels are determined by point of
care testing (POCT). With respect to the current study design; we would like to
stress that the study population will consist of patient in whom GTT is already
clinically indicated on forehand, and the inclusion is not part of the study
design.
Study burden and risks
Part 1) The burden will comprise a single phlebotomy. Part 2) Phlebotomy/POCT
during OGTT. Apart from the POCT testing, the GTT does not deviate from the
standard operating procedure in pregnant women.
Molengracht 21
Breda 4800 RK
NL
Molengracht 21
Breda 4800 RK
NL
Listed location countries
Age
Inclusion criteria
Part 1. Healthy volunteers.;Part 2. Pregnant women with an indication (as determined by a gynaecologist) to undergo an oral glucose tolerance test.
Exclusion criteria
In the first part of the experiment, there are no exclusion criteria, as the sampled population should (ideally) represent a random population.;In the second part of the experiment, subjects are excluded from analysis if the OGTT is not completed for any reason. To assess pregnancy diabetes, it is important to discriminate from a prior underlying diabetes; therefore, patients will be excluded when diabetes was already present before pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46462.015.13 |