title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02035059.
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
authors.forename: E A
authors.initials: EA
authors.lastname: Huhn
authors.affiliation: Department of Obstetrics and Gynaecology, Salzburger Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria.
authors.forename: T
authors.initials: T
authors.lastname: Fischer
authors.affiliation: Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
authors.forename: C S
authors.initials: CS
authors.lastname: Göbl
authors.affiliation: Department of Obstetrics and Gynaecology, Cantonal Hospital Aarau, Aarau, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Todesco Bernasconi
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Kreft
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Kunze
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: Schoetzau
authors.affiliation: Department of Obstetrics and Gynaecology, Salzburger Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria.
authors.forename: E
authors.initials: E
authors.lastname: Dölzlmüller
authors.affiliation: Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
authors.forename: W
authors.initials: W
authors.lastname: Eppel
authors.affiliation: Division of Obstetrics and Feto-maternal Medicine, Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Husslein
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Ochsenbein-Koelble
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Zimmermann
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Bäz
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Prömpeler
authors.affiliation: Department of Pathology, University Hospital Basel, Basel, Switzerland.
authors.forename: E
authors.initials: E
authors.lastname: Bruder
authors.affiliation: Department of Biomedicine, Laboratory of Perinatology, University Basel, Basel, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Hahn
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
authors.forename: I
authors.initials: I
authors.lastname: Hoesli
mesh_terms: D000328:Adult; D001317:Austria / Q000453:epidemiology; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism*; D016640:Diabetes, Gestational / Q000097:blood* / Q000175:diagnosis* / Q000453:epidemiology; D042241:Early Diagnosis; D005260:Female; D005353:Fibronectins / Q000097:blood*; D005858:Germany / Q000453:epidemiology; D005951:Glucose Tolerance Test / Q000379:methods*; D017127:Glycation End Products, Advanced; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008430:Maternal-Child Health Centers; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D013557:Switzerland / Q000453:epidemiology; D000093844:Glycated Proteins
chemical_list: D001786:Blood Glucose; D005353:Fibronectins; D017127:Glycation End Products, Advanced; C045099:glycated fibronectin; D000093844:Glycated Proteins
keywords: diagnosis; gestational diabetes mellitus; glycosylated fibronectin; oral glucose tolerance test; pregnancy; screening