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A Cluster Randomized Noninferiority Field Trial of Gestational Diabetes Mellitus Screening Publisher Pubmed



Ramezani Tehrani F1 ; Behboudigandevani S2 ; Farzadfar F3, 4 ; Hosseinpanah F5 ; Hadaegh F6 ; Khalili D6 ; Soleymanidodaran M7 ; Valizadeh M5 ; Abedini M8 ; Rahmati M1 ; Bidhendi Yarandi R9 ; Torkestani F10 ; Abdollahi Z11 ; Bakhshandeh M12 Show All Authors
Authors
  1. Ramezani Tehrani F1
  2. Behboudigandevani S2
  3. Farzadfar F3, 4
  4. Hosseinpanah F5
  5. Hadaegh F6
  6. Khalili D6
  7. Soleymanidodaran M7
  8. Valizadeh M5
  9. Abedini M8
  10. Rahmati M1
  11. Bidhendi Yarandi R9
  12. Torkestani F10
  13. Abdollahi Z11
  14. Bakhshandeh M12
  15. Zokaee M13
  16. Amiri M1
  17. Bidarpour F14
  18. Javanbakht M15
  19. Nabipour I16
  20. Nasli Esfahani E17
  21. Ostovar A4, 18
  22. Azizi F19
Show Affiliations
Authors Affiliations
  1. 1. Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, 1985717413, Iran
  2. 2. Faculty of Nursing and Health Sciences, Nord University, Bodo, 8049, Norway
  3. 3. Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, 1411713139, Iran
  4. 4. Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, 1411713139, Iran
  5. 5. Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, 1985717413, Iran
  6. 6. Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, 1985717413, Iran
  7. 7. Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, 1445613113, Iran
  8. 8. Infertility and cell therapy office, Transplant & Disease Treatment Center, Ministry of Health and Medical Education, Tehran, 1419943471, Iran
  9. 9. Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, 1985713834, Iran
  10. 10. Shahed University of medical Science, Tehran, 3319118651, Iran
  11. 11. Department of Nutrition, Ministry of Health and Medical Education, Tehran, 1419943471, Iran
  12. 12. Family Health Department, Ministry of Health and Medical Education, Tehran, 1419943471, Iran
  13. 13. Population, family and school health Department, Kurdistan University of Medical Sciences, Sanandaj, 6618634683, Iran
  14. 14. Kurdistan University of Medical Sciences, Sanandaj, 6618634683, Iran
  15. 15. University of Southampton, Hampshire, SO16 7NS, United Kingdom
  16. 16. The Persian Gulf Tropical Medicine Research Center, The Persian Gulf Biomedical Sciences Research Institute, Bushehr University of Medical Sciences, Bushehr, 7514763448, Iran
  17. 17. Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, 1411713139, Iran
  18. 18. Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
  19. 19. Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, 1985717413, Iran

Source: Journal of Clinical Endocrinology and Metabolism Published:2022


Abstract

Context: Although it is well-acknowledged that gestational diabetes mellitus (GDM) is associated with the increased risks of adverse pregnancy outcomes, the optimal strategy for screening and diagnosis of GDM is still a matter of debate. Objective: This study was conducted to demonstrate the noninferiority of less strict GDM screening criteria compared with the strict International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria with respect to maternal and neonatal outcomes. Methods: A cluster randomized noninferiority field trial was conducted on 35528 pregnant women; they were scheduled to have 2 phases of GDM screening based on 5 different prespecified protocols including fasting plasma glucose in the first trimester with threshold of 5.1 mmol/L (92 mg/dL) (protocols A, D) or 5.6 mmol/L (100 mg/dL) (protocols B, C, E) and either a 1-step (GDM is defined if one of the plasma glucose values is exceeded [protocol A and C] or 2 or more exceeded values are needed [protocol B]) or 2-step approach (protocols D, E) in the second trimester. Guidelines for treatment of GDM were consistent with all protocols. Primary outcomes of the study were the prevalence of macrosomia and primary cesarean section (CS). The null hypothesis that less strict protocols are inferior to protocol A (IADPSG) was tested with a noninferiority margin effect (odds ratio) of 1.7. Results: The percentages of pregnant women diagnosed with GDM and assigned to protocols A, B, C, D, and E were 21.9%, 10.5%, 12.1%, 19.4%, and 8.1%, respectively. Intention-to-treat analyses satisfying the noninferiority of the less strict protocols of B, C, D, and E compared with protocol A. However, noninferiority was not shown for primary CS comparing protocol E with A. The odds ratios (95% CI) for macrosomia and CS were: B (1.01 [0.95-1.08]; 0.85 [0.56-1.28], C (1.03 [0.73-1.47]; 1.16 [0.88-1.51]), D (0.89 [0.68-1.17]; 0.94 [0.61-1.44]), and E (1.05 [0.65-1.69]; 1.33 [0.82-2.00]) vs A. There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the 2-step compared with the 1-step screening approaches, considering multiplicity adjustment. Conclusions: The IADPSG GDM definition significantly increased the prevalence of GDM diagnosis. However, the less strict approaches were not inferior to other criteria in terms of adverse maternal and neonatal outcomes. © 2022 The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved.