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WHO 2013 Criteria for Diagnosis of Gestational Diabetes Mellitus in Low-Risk Women in Early Pregnancy: An International Prospective Cohort Study

26 Pages Posted: 24 Jan 2022

See all articles by Evelyn A. Huhn

Evelyn A. Huhn

University of Basel - Department of Obstetrics and Gynaecology

Christian S. Göbl

Medical University of Vienna - Department of Obstetrics and Gynaecology

Thorsten Fischer

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology

Monya Todesco Bernasconi

Cantonal Hospital Aarau - Department of Obstetrics and Gynaecology

Martina Kreft

University Hospital Zurich - Department of Obstetrics and Gynaecology

Mirjam Kunze

University Hospital Freiburg - Department of Obstetrics and Gynaecology

Deborah R. Vogt

University of Basel - Clinical Trial Unit

Eva Dölzlmüller

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology

Heidi Jaksch-Bogensperger

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology

Sandra Andrea Heldstab

Cantonal Hospital Aarau - Department of Obstetrics and Gynaecology

Wolfgang Eppel

Medical University of Vienna - Department of Obstetrics and Gynaecology

Peter Husslein

Medical University of Vienna - Department of Obstetrics and Gynaecology

Nicole Ochsenbein Kölble

University Hospital Zurich - Department of Obstetrics and Gynaecology

Anne Richter

University Hospital Zurich - Department of Obstetrics and Gynaecology

Elke Bäz

University Hospital Freiburg - Department of Obstetrics and Gynaecology

Bettina Winzeler

University of Basel - Department of Endocrinology, Diabetes and Metabolism

Irene Hoesli

University of Basel - Department of Obstetrics and Gynaecology

More...

Abstract

Objective: To assess the WHO 2013 criteria in early pregnancy for the detection of gestational diabetes mellitus (GDM) diagnosed by a 75g oral glucose tolerance test (OGTT) between 24th to 28th week of gestation.

Methods:

Design: Prospective multi-centre cohort study of diagnostic accuracy

Setting: Six sites in Austria, Germany and Switzerland between March 2015 and January 2019.

Participants: In a low-risk cohort, women aged 18 to 45 years with singleton pregnancies attending first trimester screening and consenting to have an early OGTT 75g in 12th to 15th week of gestation. Participants and health care providers were blinded for the performance of OGTT.

Main outcome measures: Fasting, 1- and 2-hour glucose values after the OGTT 75g in the 12th to 15th and 24th to 28th week of gestation. 

Results: Of 636 women, 74 (12%) developed GDM according to the WHO 2013 criteria between 24-28 week of gestation. Applying the WHO 2013 criteria to the early OGTT using at least one abnormal value of fasting > 5.1 mmol/L, 1-hour > 10.0 mmol/L and/or 2-hour > 8.5 mmol/L resulted in a low sensitivity of 0.35 [0.24-0.47] and a high specificity of 0.96 [0.95-0.98], a positive predictive value (PPV) of 0.57 [0.41-0.71] and a negative predictive value 0.92 [0.89-0.94]).

Conclusion: Glucose values of women who develop GDM are higher in early pregnancy. However, there is a large overlap in glucose values between women who develop GDM and those who do not. The WHO 2013 criteria applied to early pregnancy resulted in low sensitivity and PPV and therefore would not be suitable for screening for GDM in early pregnancy unadapted.

Funding: This study was supported by the Swiss National Fund, Switzerland, the Diabetes Society Basel, Switzerland and the Gottfried and Julia Bangerter- Rhyner-Foundation, Bern, Switzerland. Researchers were independent from funders. The funders did not influence analysis of data, decision of publication or submission of the manuscript

Declaration of Interest: None to declare.

Ethical Approval: The study was approved by each local institutional review board in Basel (Ethikkommission Nordostschweiz (EKNZ)), Zurich, Freiburg, Salzburg and Vienna.

Keywords: Gestational diabetes mellitus, diagnostic accuracy, screening, oral glucose tolerance test, WHO 2013 criteria, early pregnancy

Suggested Citation

Huhn, Evelyn A. and Göbl, Christian S. and Fischer, Thorsten and Todesco Bernasconi, Monya and Kreft, Martina and Kunze, Mirjam and Vogt, Deborah R. and Dölzlmüller, Eva and Jaksch-Bogensperger, Heidi and Heldstab, Sandra Andrea and Eppel, Wolfgang and Husslein, Peter and Ochsenbein Kölble, Nicole and Richter, Anne and Bäz, Elke and Winzeler, Bettina and Hoesli, Irene, WHO 2013 Criteria for Diagnosis of Gestational Diabetes Mellitus in Low-Risk Women in Early Pregnancy: An International Prospective Cohort Study. Available at SSRN: https://ssrn.com/abstract=4016490 or http://dx.doi.org/10.2139/ssrn.4016490

Evelyn A. Huhn

University of Basel - Department of Obstetrics and Gynaecology ( email )

Spitalstrasse 21
Basel, 4031
Switzerland
+49 151 5123 80 38 (Phone)

Christian S. Göbl

Medical University of Vienna - Department of Obstetrics and Gynaecology ( email )

Austria

Thorsten Fischer

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology ( email )

Salzburg
Austria

Monya Todesco Bernasconi

Cantonal Hospital Aarau - Department of Obstetrics and Gynaecology ( email )

Switzerland

Martina Kreft

University Hospital Zurich - Department of Obstetrics and Gynaecology ( email )

Switzerland

Mirjam Kunze

University Hospital Freiburg - Department of Obstetrics and Gynaecology ( email )

Germany

Deborah R. Vogt

University of Basel - Clinical Trial Unit ( email )

Basel
Switzerland

Eva Dölzlmüller

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology ( email )

Salzburg
Austria

Heidi Jaksch-Bogensperger

Paracelsus Medical University Salzburg - Department of Obstetrics and Gynaecology ( email )

Salzburg
Austria

Sandra Andrea Heldstab

Cantonal Hospital Aarau - Department of Obstetrics and Gynaecology ( email )

Switzerland

Wolfgang Eppel

Medical University of Vienna - Department of Obstetrics and Gynaecology ( email )

Austria

Peter Husslein

Medical University of Vienna - Department of Obstetrics and Gynaecology ( email )

Austria

Nicole Ochsenbein Kölble

University Hospital Zurich - Department of Obstetrics and Gynaecology ( email )

Switzerland

Anne Richter

University Hospital Zurich - Department of Obstetrics and Gynaecology ( email )

Switzerland

Elke Bäz

University Hospital Freiburg - Department of Obstetrics and Gynaecology ( email )

Germany

Bettina Winzeler

University of Basel - Department of Endocrinology, Diabetes and Metabolism ( email )

Basel, 4031
Switzerland

Irene Hoesli

University of Basel - Department of Obstetrics and Gynaecology ( email )

Spitalstrasse 21
Basel, 4031
Switzerland

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