The unmet need for universal testing for

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Article Type: Commentary Commentary

The unmet need for universal testing for hyperglycemia in pregnancy and the FIGO Guideline.

Anil Kapur*1, Tahir Mahmood#1 and Moshe Hod‡2 *

Chairman World Diabetes Foundation

#

President European Board and College of Obstetrics and Gynecology



President European Association of Perinatal Medicine

1

Member FIGO Working Group on Hyperglycemia in Pregnancy

2

Chairman FIGO Working Group on Hyperglycemia in Pregnancy

Corresponding Author: Prof Moshe Hod Email: [email protected] Tel: 00972528888899

Running head: The FIGO universal testing for hyperglycemia in pregnancy

Key Words: Hyperglycemia in Pregnancy; Europe; FIGO Guideline

Tweetable abstract: The impact of hyperglycemia in pregnancy on perinatal outcomes and future burden of NCDs in Europe

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/1471-0528.14659 This article is protected by copyright. All rights reserved.

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The St. Vincent's Declaration1 outlined commitments to improve diabetes care in Europe. One amongst its several ambitious goals was to achieve pregnancy outcomes in women with diabetes that approximate those of women without diabetes. Given that most European governments were co-signatories and the declaration had support of the World Health Organization (WHO) Regional Office for Europe and the International Diabetes Federation (IDF), it was reasonable to expect that swift action would be taken. Alas, even after a quarter of a century most targets including the one on pregnant women with diabetes remain elusive2. Like elsewhere in the world, the prevalence of diabetes in Europe, among all age groups, including people in the reproductive age, is increasing. It already affects about 60 million people, and is projected to increase to 71 million people by 2040. There is an equally high burden of pre-diabetes approximately 32 million which is likely to increase to about 37million by 2040.3 . Overweight, obesity and increasing maternal age increase the risk for hyperglycemia in pregnancy (HIP), Approximately one in three pregnant women in Europe are obese or overweight4. The age at childbirth continues to rise and in many countries, over 20% of births are to women aged 35 years or more4. More than one third of people with diabetes and a majority of people with prediabetes remain undiagnosed; particularly the young and women, as they have never been tested given that diabetes is mistakenly believed to only affect the elderly. As a consequence, apart from the rising rates of gestational diabetes mellitus, Europe has to also contend with the increasing burden of previously undiagnosed type 2 diabetes in pregnancy (DIP). It should therefore be no surprise that hyperglycemia in pregnancy (HIP) is one of the most common medical conditions affecting women during pregnancy. According to IDF, an estimated 14% of live births in Europe may be impacted by hyperglycemia during pregnancy3. Non-white immigrant mothers that account for a significant proportion of pregnancies4 are even more vulnerable. Although higher weight and maternal age are risk factors for HIP, in practice, only half of the women with HIP have these. The sensitivity to detect GDM using risk factors is poor, thus supporting the need for universal testing5. There is no consensus on the optimal approach to testing for HIP in Europe6 particularly, on the utility of continued use of risk-based testing versus universal testing. There is evidence of both immediate and long term health and economic benefits of testing, diagnosis and management of HIP and providing post-partum preventive care. However, some physicians express concerns that universal testing and (consequently) increased diagnosis of GDM would place additional logistical and economic challenges to healthcare systems, as oral glucose tolerance tests (OGTT) are time-consuming and incur costs. On the other hand, the problem of complex protocols for testing based on risk factors, which places high demands on healthcare providers, with the consequent lower compliance and missed diagnosis has not been acknowledged. Inadequately managed (and by corollary undiagnosed) HIP significantly increases risk of pregnancy complications: hypertension, obstructed labor, postpartum hemorrhage, infections, still births, premature delivery, both large and small for gestational age babies, congenital anomalies, newborn deaths due to respiratory problems, hypoglycemia and birth injuries7. The risk and number of these complications are directly related to level of maternal hyperglycemia 8. While infant and maternal mortality in Europe is generally quite low and continues to decline, perinatal mortality and morbidity remains a major concern. The incidence of pre-term and very preterm births, fetal growth restriction, and congenital anomalies has increased in many countries,

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reflecting limited achievements in preventing high risk situations4. About one-third of all fetal deaths and 40% of all neonatal deaths in Europe were among babies born before 28 weeks of gestation4. The proportions of live births with birth weight under 2500 g vary from under 4% to slightly over 9%. Stillbirths have also declined less rapidly, and in many cases their causes remain unknown4. Increased clinical and community awareness of the risks associated with common pre-gestational and gestational medical disorders (e.g., diabetes and hypertension) and implementation of best practice guidelines might improve management and lower associated stillbirth rates9. Most of the maternal deaths in Europe, as elsewhere in the world are directly due to hemorrhage, hypertension, thromboembolic disease, sepsis and obstructed labor, the risk for which is considerably increased with HIP. With the introduction of targeted interventions, there are declining rates of direct maternal deaths within Europe. Therefore efforts to further improve maternal health will have to be refocused on reduction of maternal morbidity and indirect causes of mortality. Addressing obesity and HIP may help lower maternal and newborn morbidity and mortality by lowering the risk of pregnancy complications such as pre-term births, still births, congenital anomalies, small and large babies which are critical problems for maternal and child health in Europe4. Without preventive care, almost half of women with gestational diabetes go on to develop type 2 diabetes and a significant proportion develops premature cardiovascular disease within 10 years of childbirth10-12. Children born to women with HIP are also at very high risk of obesity, early onset type 2 diabetes and cardiovascular disease whereby, HIP perpetuates these conditions into the next generation. Focusing on maternal obesity and HIP screening during pregnancy provides a unique opportunity to integrate services which would lower traditional maternal and perinatal morbidity and mortality indicators and address inter-generational prevention of obesity, diabetes, hypertension and CVD. But how can we achieve this when we bury our heads in sand and continue to disregard the basic premise of testing all pregnant women for hyperglycemia? It is unbelievable, that health care funding has not been prioritized for this and for targeted, preventive post-partum care and health promotion for high-risk mother and child pairs. An important reason for the lack of progress on the St. Vincent's goal related to pregnancy in women with diabetes perhaps was the lack of ownership and involvement of obstetricians. Most of the attention on gestational diabetes including setting diagnostic cut off values in the past has been based on the future risk of type 2 diabetes with scant attention paid to the perinatal outcomes particularly among women with the so called "mild gestational hyperglycemia". Studies in the last decade have shown significant associations between adverse pregnancy outcomes and levels of maternal glucose considered within the nondiabetic range8, 13. Meta-analysis of randomized control trials shows that treatment of gestational hyperglycemia improves pregnancy outcomes14. Therefore the recent focus of the International Federation of Gynecology and Obstetrics (FIGO) on hyperglycemia in pregnancy, resulting in the release of pragmatic guidelines5 at the FIGO World Congress in Vancouver in 2015 and the subsequent setting up a working group on HIP is very welcome.

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FIGO demands greater attention on the links between maternal health and non-communicable diseases in the sustainable developmental goals agenda; in particular, to gestational hyperglycemia and its propensity to fuel the global diabetes, obesity and cardiovascular disease pandemic. FIGO also asks for public health measures to increase awareness, access, affordability, and acceptance of preconception counseling, and prenatal and postnatal services for women of reproductive age to be prioritized. This stance is in line with the UN Declaration on non-communicable diseases15 and the policy brief of the European Institute of Women’s Health (EIWH) (http://eurohealth.ie/wpcontent/uploads/2013/02/women_and_diabetes_policy_brief.pdf). FIGO also recommends that all pregnant women should be tested for hyperglycemia during pregnancy using a one-step procedure as a minimum standard and encourages all countries and its member associations to adapt and promote strategies to ensure this. Following a pregnancy complicated by GDM, the postpartum period provides an important platform to initiate beneficial health practices for both mother and child to reduce the future burden of obesity, diabetes and cardiovascular diseases. FIGO recommends that obstetricians should establish links with family physicians, internists, pediatricians, and other healthcare providers to support postpartum follow-up of mothers with HIP and their children. A follow-up program linked to the child’s vaccination and regular health check-up visits provides an opportunity for continued engagement with the high risk mother child pair. FIGO seeks greater international research collaboration to address the knowledge gaps to better understand the links between maternal health and non-communicable diseases and create evidence-based best practice standards for testing, management, and care of women with GDM. The FIGO guideline has received widespread support and recognition from many professional organizations from across the world particularly from Europe, Australia, Canada and the developing world including organizations in India, China and Africa. The European Association of Perinatal Medicine (EAPM), the European Board and College of Obstetrics and Gynecology (EBCOG) and the International Association of Diabetes in Pregnancy Study Groups (IADPSG) were amongst the first to endorse and support the document. It is about time that health planners and policy makers in Europe pay heed to these recommendations and take appropriate steps to implement the necessary actions. Acknowledgements: The authors wish to acknowledge the support of the International Federation of Gynecology and Obstetrics (FIGO) and colleagues in the FIGO HIP working group. Disclosure of interests: The authors declare no conflict of interest in relation to the topic of this publication. The ICMJE disclosure forms are available as online supporting information. Contribution to authorship: AK prepared the first draft of the commentary which was commented and reviewed by TM and MH. All authors approved the final text. Details of ethics approval: This being a commentary no ethics approval was required Funding: The authors did not receive any funding for writing this paper.

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References 1. WHO/IDF Saint Vincent Declaration WorkingGroup. Diabetes Mellitus in Europe: a Problemat all Ages in all Countries. A Model forPrevention and Self Care. ActaDiabetol 1990;27:181-3 2. Colstrup M, Mathiesen ER, Damm P, Jensen DM, Ringholm L. Pregnancy in women with type 1 diabetes: have the goals of St. Vincent declaration been met concerning foetal and neonatal complications? J Matern Fetal Neonatal Med. 2013 Nov;26(17):1682-6. doi: 10.3109/14767058.2013.794214. Epub 2013 May 15 3. International Diabetes Federation IDF Diabetes Atlas 7th Edition http://www.diabetesatlas.org/ 4. EUROPEAN PERINATAL HEALTH REPORT. Health and Care of Pregnant Women and Babies in Europe in 2010.http://www.europeristat.com/reports/european-perinatal-health-report2010.html(accessed on 28th November 2016) 5. Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, Cabero Roura L, McIntyre HD, Morris JL, Divakar H. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on Gestational Diabetes Mellitus: A Pragmatic Guide for Diagnosis, Management, and Care. International Journal of Gynecology and Obstetrics 131 S3 (2015) S173–S211 6. Benhalima K, Mathieu C, Van Assche A, Damm P, Devlieger R, Mahmood T, Dunne F. Screening for gestational diabetes in Europe: where do we stand and how to move forward?: A scientific paper commissioned by the European Board & College of Obstetrics and Gynaecology (EBCOG).Eur J Obstet Gynecol Reprod Biol. 2016 Jun; 201:192-6. doi: 10.1016/j.ejogrb.2016.04.002. Epub 2016 Apr 11 7. Lim CC, Mahmood T. Obesity in Pregnancy (in) Obesity in Pregnancy (eds) Sabaratnam Arulkumaran: Best Practice and Research Clinical obstetrics & Gynaecology:309-319;29(3), 2015. Elsevier 8. HAPO Study Cooperative Research Group. Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991–2002. 9. Flenady V, Koopmans L, Middleton P, Frøen JF, Smith GC, Gibbons K, Coory M, Gordon A, Ellwood D, McIntyre HD, Fretts R, Ezzati M. Major risk factors for stillbirth in high-income countries: a systematic review and meta-analysis. Lancet. 2011 Apr 16;377(9774):1331-40. doi: 10.1016/S0140-6736(10)62233-7 10. Waters TP, Dyer AR, Scholtens DM, Dooley SL, Herer E, Lowe LP, Oats JJ, Persson B, Sacks DA, Metzger BE, Catalano PM; HAPO Cooperative Study Research Group.Maternal and Neonatal Morbidity for Women Who Would Be Added to the Diagnosis of GDM Using IADPSG Criteria: A Secondary Analysis of the Hyperglycemia and Adverse Pregnancy Outcome Study.Diabetes Care. 2016 Dec;39(12):2204-2210. Epub 2016 Sep 15 11. Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, et al. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab 2008;93(12):4774–9. 12. Aroda VR, Christophi CA, Edelstein SL, Zhang P, Herman WH, Barrett-Connor E, et al The effect of lifestyle intervention and metformin on preventing or delaying diabetes among

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women with and without gestational diabetes: the diabetes prevention program outcomes study 10-year follow-up. J Clin Endocrinol Metab 2015;100(4):1646–53. 13. Bao W, Tobias DK, Bowers K, Chavarro J, Vaag A, Grunnet LG, et al. Physical activity and sedentary behaviors associated with risk of progression from gestational diabetes mellitus to type 2 diabetes mellitus: a prospective cohort study. JAMA Intern Med 2014;174(7):1047– 55. 14. Horvath K, Koch K, Jeitler K, Matyas E, Bender R, Bastian H, Lange S, Siebenhofer A. Effects of treatment in women with gestational diabetes mellitus: systematic review and metaanalysis. BMJ. 2010 Apr 1;340: c1395. doi: 10.1136/bmj.c1395 15. General Assembly Resolution on Prevention and control of non-communicable diseases (A/RES/64/265).http://www.un.org/en/ga/president/65/issues/A-RES-65-238.pdf (accessed on 28th November 2016)

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