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Optimisation of the (pre)analysis for diabetes gravidarum.

Optimisation of the (pre)analysis for diabetes gravidarum. - Optimisation of the (pre)analysis for diabetes gravidarum.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40427
Enrollment
120
Registered
2014-06-17
Start date
2014-09-15
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Diabetes gravidarum pregnancy diabetes

Interventions

None listed

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)