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Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035059
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
University Hospital, Zürich
Cantonal Hospital of Aarau, Switzerland
Vienna General Hospital
Paracelsus Medical University
University Hospital Freiburg
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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).

Condition or disease
Pregnancy Gestational Diabetes Mellitus

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.

Study Design
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Study Type : Observational
Actual Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Women with/without gestational diabetes
Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood Saliva

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Women
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Women's Hospital, University Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital, Zürich
Cantonal Hospital of Aarau, Switzerland
Vienna General Hospital
Paracelsus Medical University
University Hospital Freiburg
Investigators
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Study Director: Evelyn Huhn, MD Women's Hospital, University Basel
Principal Investigator: Irene Hösli, MD Women's Hospital, University Basel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02035059    
Other Study ID Numbers: EKBB195/13
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by University Hospital, Basel, Switzerland:
Oral Glucose Tolerance Test
Fibronectin
Adiponectin
Copeptin
Cortisol
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications