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Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial

Huhn, Evelyn Annegret and Fischer, Thorsten and Gobl, Christian S. and Todesco Bernasconi, M. and Kreft, Martina and Kunze, Mirjam and Schoetzau, Andreas and Dolzlmuller, Eva and Eppel, W. and Husslein, P. and Ochsenbein-Koelble, Nicole and Zimmermann, R. and Baz, Elke and Prömpeler, Heinrich and Bruder, Elisabeth and Hahn, Sinuhe and Hoesli, Irene. (2016) Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial. BMJ Open, 6 (10). e012115.

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Official URL: https://edoc.unibas.ch/61783/

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Abstract

INTRODUCTION: As the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an 'early' oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort. METHODS AND ANALYSIS: In a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany. Women are screened for pre-existing diabetes mellitus and GDM by an 'early' OGTT 75 g and/or the new biomarker, glyFn, at 12-15 weeks of gestation. Different screening strategies are compared to evaluate the impact on detection of GDM by an OGTT 75 g at 24-28 weeks of gestation as recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). A new screening algorithm is created by using multivariable risk estimation based on 'early' OGTT 75 g and/or glyFn results, incorporating maternal risk factors. Recruitment began in May 2014. ETHICS AND DISSEMINATION: This study received ethical approval from the ethics committees in Basel, Zurich, Vienna, Salzburg and Freiburg. It was registered under http://www.ClinicalTrials.gov (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02035059.
Faculties and Departments:03 Faculty of Medicine > Departement Biomedizin > Department of Biomedicine, University Hospital Basel > Prenatal Medicine (Hahn)
UniBasel Contributors:Hahn, Sinuhe
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BMJ Publishing Group
e-ISSN:2044-6055
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:28 Jul 2020 13:22
Deposited On:23 Jul 2020 13:18

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