Skip to content

Predictability of Gestational Diabetes Mellitus in First and Second Trimester

Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02035059
Acronym
GDMPredict
Enrollment
820
Registered
2014-01-14
Start date
2014-05-01
Completion date
2018-12-31
Last updated
2019-04-26

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

Conditions

Gestational Diabetes Mellitus, Pregnancy

Keywords

Oral Glucose Tolerance Test, Fibronectin, Adiponectin, Copeptin, Cortisol

Brief summary

The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

Detailed description

It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels. The primary outcome will be development of gestational diabetes mellitus in the second or third trimester. The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Interventions

None listed

Sponsors

University Hospital, Zürich
CollaboratorOTHER
Cantonal Hospital of Aarau, Switzerland
CollaboratorOTHER
Vienna General Hospital
CollaboratorOTHER
Paracelsus Medical University
CollaboratorOTHER
University Hospital Freiburg
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy singleton pregnancies * Women at least 18 years old and not under guardianship

Exclusion criteria

* Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus * Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment * Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Development of Gestational Diabetes in second/third trimester24-28 weeks of gestationDevelopment of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026