Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)
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|ClinicalTrials.gov Identifier: NCT02035059|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 26, 2019
|Condition or disease|
|Pregnancy Gestational Diabetes Mellitus|
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.
|Study Type :||Observational|
|Actual Enrollment :||820 participants|
|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|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Women with/without gestational diabetes
Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
- Development of Gestational Diabetes in second/third trimester [ Time Frame: 24-28 weeks of gestation ]Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035059
|Women's Hospital, University Basel|
|Basel, Basel-Stadt, Switzerland, 4031|
|Study Director:||Evelyn Huhn, MD||Women's Hospital, University Basel|
|Principal Investigator:||Irene Hösli, MD||Women's Hospital, University Basel|