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.

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.

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

Substances

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

Associated data

  • ClinicalTrials.gov/NCT02035059