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.
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Huhn EA
Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
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Fischer T
Department of Obstetrics and Gynaecology, Salzburger Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria.
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Göbl CS
Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
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Todesco Bernasconi M
Department of Obstetrics and Gynaecology, Cantonal Hospital Aarau, Aarau, Switzerland.
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Kreft M
Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
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Kunze M
Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
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Schoetzau A
Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
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Dölzlmüller E
Department of Obstetrics and Gynaecology, Salzburger Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria.
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Eppel W
Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
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Husslein P
Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
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Ochsenbein-Koelble N
Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
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Zimmermann R
Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
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Bäz E
Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
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Prömpeler H
Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
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Bruder E
Department of Pathology, University Hospital Basel, Basel, Switzerland.
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Hahn S
Department of Biomedicine, Laboratory of Perinatology, University Basel, Basel, Switzerland.
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Hoesli I
Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
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English
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.
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Language
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Open access status
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gold
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Persistent URL
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https://sonar.ch/global/documents/134676
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