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NCT02035059 Clinical Trial

Predictability of Gestational Diabetes Mellitus in First and Second Trimester

Pregnancy Clinical Trial

— GDMPredict  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02035059
Other study ID # EKBB195/13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2014
Est. completion date December 31, 2018

Study information
Verified date April 2019
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 820
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Women`s Hospital, University Basel Basel Basel-Stadt

Sponsors (6)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Cantonal Hospital of Aarau, Switzerland, Paracelsus Medical University, University Hospital Freiburg, University Hospital, Zürich, Vienna General Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of Gestational Diabetes in second/third trimester Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g 24-28 weeks of gestation
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