Optimisation of the (pre)analysis for diabetes gravidarum.

Completed

• Conditions: Diabetes gravidarum; pregnancy diabetes; 10018424; 10010273

• Registration Number: NL-OMON40427
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1) Stability of in vitro glucose levels after phlebotomy under a variety<br /><br>of (pre)analytical variables, such as the choice of the collection tube and<br /><br>the optimal turn-around-time. Part 2) the applicability of POCT testing in the<br /><br>diagnosis of GDM in comparison with phlebotomy and determination of the<br /><br>possible clinical misdiagnosis of GDM if one deviates from the optimal<br /><br>(pre)analytical variables.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>None</p><br>