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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
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
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