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©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
Estimated impact of introduction of new diagnostic criteria for gestational diabetes mellitus
Leon de Wit, Anna B Zijlmans, Doortje Rademaker, Christiana A Naaktgeboren, J Hans DeVries, Arie Franx, Rebecca C Painter, Bas B van Rijn
Leon de Wit, Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht 3584 EA, Netherlands
Anna B Zijlmans, Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede 6716 RP, Netherlands
Doortje Rademaker, Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers- Location AMC, Amsterdam 1105 AZ, Netherlands
Christiana A Naaktgeboren, Rebecca C Painter, Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers–Location AMC, Amsterdam 1105 AZ, Netherlands
J Hans DeVries, Department of Endocrinology, Amsterdam University Medical Centers–Location AMC, Amsterdam 1105 AZ, Netherlands
Arie Franx, Bas B van Rijn, Department of Obstetrics and Fetal Medicine, Erasmus MC Sophia Children Hospital, Rotterdam 3015 GD, Netherlands
Author contributions: van Rijn BB contributed to the conception of the study and is the guarantor for the contents of the article, and as such, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the analyses performed; de Wit L and Zijlmans AB collected the data, performed the analyses, drafted the manuscript and coordinated revisions; Statistical support was provided by Naaktgeboren CA; All authors have contributed to the design of the study, performed interpretation of the data and critical revision of the article for important intellectual content and approved the final version of the manuscript for publication.
Institutional review board statement: This study was exempt from approval of the Medical Research Ethics Committee of the University Medical Center Utrecht (reference number 16-711/C), which granted a waiver after reviewing the protocol because the Dutch Medical Research Involving Human Subjects Act (WMO) did not apply to this study.
Informed consent statement: With this document we would like to inform you that for the manuscript regarding our study entitled ’Estimated impact of introduction of new diagnostic criteria for gestational diabetes mellitus’ no individual informed consent forms have been signed by participants as approved by our Institutional Review Board (MREC of the University Medical Center Utrecht). See the attached Institutional Review Board Approval Form.
Conflict-of-interest statement: The authors declare that there is no duality of interest associated with this manuscript.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
http://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Bas B van Rijn, MD, MSc, PhD, Assistant Professor, Department of Obstetrics and Fetal Medicine, Erasmus MC Sophia Children Hospital, Doctor Molewaterplein 40, Rotterdam 3015 GD, Netherlands. b.vanrijn@erasmusmc.nl
Received: February 2, 2021
Peer-review started: February 2, 2021
First decision: February 25, 2021
Revised: March 12, 2021
Accepted: April 25, 2021
Article in press: April 25, 2021
Published online: June 15, 2021
BACKGROUND
Implementation of new diagnostic criteria for gestational diabetes mellitus (GDM) are still a subject of debate, mostly due to concerns regarding the effects on the number of women diagnosed with GDM and the risk profile of the women newly diagnosed.
AIM
To estimate the impact of the World Health Organization (WHO) 2013 criteria compared with the WHO 1999 criteria on the incidence of gestational diabetes mellitus as well as to determine the diagnostic accuracy for detecting adverse pregnancy outcomes.
METHODS
We retrospectively analyzed a single center Dutch cohort of 3338 women undergoing a 75 g oral glucose tolerance test where the WHO 1999 criteria to diagnose GDM were clinically applied. Women were categorized into four groups: non-GDM by both criteria, GDM by WHO 1999 only (excluded from GDM), GDM by WHO 2013 only (newly diagnosed) and GDM by both criteria. We compared maternal characteristics, pregnancy outcomes and likelihood ratios for adverse pregnancy outcomes.
RESULTS
Retrospectively applying the WHO 2013 criteria increased the cohort incidence by 13.1%, from 19.3% to 32.4%. Discordant diagnoses occurred in 21.3%; 4.1% would no longer be labelled as GDM, and 17.2% were newly diagnosed. Compared to the non-GDM group, women newly diagnosed were older, had higher rates of obesity, higher diastolic blood pressure and higher rates of caesarean deliveries. Their infants were more often delivered preterm, large-for-gestational-age and were at higher risk of a 5 min Apgar score < 7. Women excluded from GDM were older and had similar pregnancy outcomes compared to the non-GDM group, except for higher rates of shoulder dystocia (4.3% vs 1.3%, P = 0.015). Positive likelihood ratios for adverse outcomes in all groups were generally low, ranging from 0.54 to 2.95.
CONCLUSION
Applying the WHO 2013 criteria would result in a substantial increase in GDM diagnoses. Newly diagnosed women are at increased risk for pregnancy adverse outcomes. This risk, however, seems to be lower than those identified by the WHO 1999 criteria. This could potentially influence the treatment effect that can be achieved in this group. Evidence on treatment effects in newly diagnosed women is urgently needed.
Core Tip: The World Health Organization 2013 criteria would increase the number of women diagnosed with gestational diabetes mellitus to almost one third of the population tested. Our data confirm that the new criteria indeed identify women at risk, implying potential for treatment. However, we also show that implementation of the criteria would result in a great increase of women diagnosed with gestational diabetes mellitus, resulting in over half of the women to be subjected to unevaluated treatment, as evidenced by the treatment effect in this group is currently absent. This stresses the need for randomized trials to evaluate the new criteria prior to implementation.
