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. 2016 Oct 12;6(10):e012115. doi: 10.1136/bmjopen-2016-012115.


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 (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number: NCT02035059.

Keywords: diagnosis; gestational diabetes mellitus; glycosylated fibronectin; oral glucose tolerance test; pregnancy; screening.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Austria / epidemiology
  • Blood Glucose / analysis
  • Blood Glucose / metabolism*
  • Diabetes, Gestational / blood*
  • Diabetes, Gestational / diagnosis*
  • Diabetes, Gestational / epidemiology
  • Early Diagnosis
  • Female
  • Fibronectins / blood*
  • Germany / epidemiology
  • Glucose Tolerance Test / methods*
  • Glycation End Products, Advanced
  • Humans
  • Mass Screening / methods
  • Maternal-Child Health Centers*
  • Practice Guidelines as Topic
  • Pregnancy
  • Prevalence
  • Prospective Studies
  • Risk Factors
  • Switzerland / epidemiology


  • Blood Glucose
  • Fibronectins
  • Glycation End Products, Advanced
  • glycated fibronectin

Associated data