Clinical practice guidelines for diabetes in pregnancy 2017 ( Thực hành lâm sàng Đái tháo đường trong thai kỳ 2017)

Thực hành lâm sàng Đái tháo đường trong thai kỳ 2017 của Malaysia, Hướng dẫn chi tết, dễ hiểu dễ áp dụng thực hành lâm sàng.Clinical practice guidelines for diabetes in pregnancy 2017 Thực hành lâm sàng Đái tháo đường trong thai kỳ 2017

CLINICAL PRACTICE GUIDELINES 2017 MOH/P/PAK/xxx.17(GU) MANAGEMENT OF DIABETES IN PREGNANCY Ministry of Health Malaysia Malaysian Endocrine & Metabolic Society Obstetrical and Gynaecological Society of Malaysia (OGSM) i Academy of Medicine Malaysia CPG Management of Diabetes in Pregnancy 2017 Published by: Malaysia Health Technology Assessment Section (MaHTAS) Medical Development Division, Ministry of Health Malaysia Level 4, Block E1, Precinct Federal Government Administrative Centre 62590, Putrajaya, Malaysia Copyright The copyright owner of this publication is MaHTAS Content may be reproduced in any number of copies and in any format or medium provided that a copyright acknowledgement to MaHTAS is included and the content is not changed, not sold, nor used to promote or endorse any product or service, and not used in an inappropriate or misleading context ISBN: Available on the following websites: http://www.moh.gov.my http://www.acadmed.org.my http://www.mems.my http://www.ogsm.org.my Also available as an app for Android and IOS platform: MyMaHTAS STATEMENT OF INTENT These clinical practice guidelines (CPG) are meant to be guides for clinical practice, based on the best available evidence at the time of development Adherence to these guidelines may not necessarily guarantee the best outcome in every case Every healthcare provider is responsible for the management of his/her unique patient based on the clinical picture presented by the patient and the management options available locally Every care is taken to ensure that this publication is correct in every detail at the time of publication However, in the event of errors or omissions, corrections will be published in the web version of this document, which is the definitive version at all times This version can be found on the websites mentioned above UPDATING THE CPG These guidelines were issued in 2017 and will be reviewed in a minimum period of four years (2021) or sooner if new evidence becomes available When it is due for updating, the Chairman of the CPG or National Advisor of the related specialty will be informed about it A discussion will be done on the need for a revision including the scope of the revised CPG A multidisciplinary team will be formed and the latest systematic review methodology used by MaHTAS will be employed ii CPG Management of Diabetes in Pregnancy No Title Key Recommendations Levels of Evidence and Formulation of Recommendation Guidelines Development and Objectives Development Group Review Committee External Reviewers Algorithm A: Screening and Diagnosis of Diabetes in Pregnancy Algorithm B: Intrapartum Glucose Monitoring for Diabetes in Pregnancy in Active Labour Algorithm C: Insulin Infusion and Titration in Active Labour Algorithm D: Management of Neonatal Hypoglycaemia 2017 Page v vii viii x xi xii INTRODUCTION SCREENING AND DIAGNOSIS MANAGEMENT IN PREGNANT WOMEN AT RISK OF DEVELOPING GDM 3.1 Medical Nutrition Therapy 3.2 Exercise 6 MANAGEMENT IN WOMEN WITH PRE-EXISTING DIABETES 4.1 Pre-conception Care and Counselling 4.2 Contraception 4.3 Glycaemic Control 4.4 Folic Acid Supplementation 9 9 10 ANTENATAL MANAGEMENT OF DIABETES IN PREGNANCY 5.1 Glycaemic Control 5.2 Medical Nutrition Therapy 5.3 Oral Antidiabetic Agents 5.4 Insulin 5.5 Pre-eclampsia Prophylaxis 5.6 Assessment of Diabetes Complications 5.7 Fetal Surveillance 5.8 Timing and Mode of Delivery 11 11 12 13 14 16 16 17 18 INTRAPARTUM GLYCAEMIC CONTROL FOR DIABETES IN PREGNANCY 19 POST-PARTUM MANAGEMENT OF DIABETES IN PREGNANCY 7.1 Post-partum Glucose Monitoring 7.2 Post-partum Use of Metformin 7.3 Breastfeeding 7.4 Post-partum Contraception 7.5 Post-partum Lifestyle Intervention 19 19 20 20 20 20 MANAGEMENT OF NEONATES OF MOTHERS WITH DIABETES 21 MANAGEMENT OF SPECIAL CONDITIONS IN DIABETES IN PREGNANCY 9.1 Continuous Subcutaneous Insulin Infusion 9.2 Corticosteroids 9.3 Fasting 21 21 21 22 10 REFERRAL TO SECONDARY / TERTIARY CARE 22 iii CPG Management of Diabetes in Pregnancy No 11 Title IMPLEMENTING THE GUIDELINES 2017 Page 23 REFERENCES 24 Appendix 1: Appendix 2: Appendix 3: 30 31 32 33 37 38 39 41 42 43 43 43 Examples of Search Strategy Clinical Questions Carbohydrate Content of Common Malaysian Foods Food Groups and Exchange Lists Glycaemic Index List Sample Menu Appendix 4: Medication Table Appendix 5: Insulin Infusion Preparation List of Abbreviations Acknowledgement Disclosure Statement Source of Funding iv CPG Management of Diabetes in Pregnancy 2017 KEY RECOMMENDATIONS The following recommendations were highlighted by the guidelines Development Group as the key clinical recommendations that should be prioritised for implementation Screening  Screening for gestational diabetes mellitus based on risk factors using 75 gram oral glucose tolerance test (OGTT) should be done at booking o If the test is negative, it should be repeated at 24-28 weeks of gestation  For women at the age of 25 or more with no other risk factors, OGTT should be done at 24-28 weeks of gestation  Overt diabetes in pregnancy should be managed as pre-existing diabetes Pre-conception Care  Pre-conception care of women with pre-existing diabetes which involve multidisciplinary team should be fully implemented in all healthcare facilities a Antenatal Management of Diabetes in Pregnancy  Self-monitoring of blood glucose (SMBG) should be done in diabetes in pregnancy The blood glucose targets should be as the following: o fasting or pre-prandial: ≤5.3 mmol/L o 1-hour post-prandial: ≤7.8 mmol/L o 2-hour post-prandial: ≤6.7 mmol/L  The frequency of SMBG should be individualised in diabetes in pregnancy  Pregnant women with pre-existing diabetes on multiple daily insulin (MDI) injection regimen should perform home blood glucose monitoring (HBGM) at least three times daily It can be done at fasting, pre-prandial, 1-hour post-prandial or bedtime  Women with gestational diabetes mellitus (GDM) on MDI injection regimen should perform HBGM two to three times daily, for two to three days a week  Pregnant women with type diabetes mellitus or GDM on diet and exercise therapy, oral antidiabetic agents (OAD), single-dose intermediate-acting or long-acting insulin should perform fasting and 1-hour post-prandial HBGM at least once daily until glucose targets are reached  Pregnant women who are on insulin or OAD should maintain their capillary plasma glucose level above 4.0 mmol/L  Pregnant women with diabetes should be given individualised medical nutrition therapy which includes carbohydrate-controlled meal plan and monitoring of gestational weight gain  In gestational diabetes mellitus, oral antidiabetic agents (OAD) should be offered when medical nutrition therapy fails o OAD should be prescribed after consultation with specialists o Metformin is the preferred OAD  OAD should be continued in women who are already on the treatment before pregnancy v CPG Management of Diabetes in Pregnancy 2017  Insulin therapy can be initiated at outpatient setting in pregnant women with diabetes  The preferred choice of insulin regime in diabetes in pregnancy is multiple daily injections  Insulin analogues should be continued during pregnancy in women with pre-existing diabetes who are already on the treatment  Rapid insulin analogue may be considered as an option, particularly in patients with frequent hypoglycaemia or post-prandial hyperglycaemia using human insulin during pregnancy  Pregnant women with pre-existing diabetes should be offered ultrasound scan: o at 11-14 weeks of gestation for dating and major structural malformation o at 18-20 weeks of gestation for detailed structural anatomy scan (by a trained specialist or ultrasonographer)  In women with pre-existing diabetes and gestational diabetes mellitus, serial growth scan should be performed every four weeks from 28 to 36 weeks of gestation  In women with pre-existing diabetes or gestational diabetes mellitus who develop maternal or fetal complications, elective delivery before 37+0 weeks should be considered Intrapartum Management of Diabetes in Pregnancy  In women with diabetes, capillary blood glucose should be maintained between 4.0-7.0 mmol/L during labour and delivery Post-partum Management of Diabetes in Pregnancy  In women with history of gestational diabetes mellitus, oral glucose tolerance test should be performed at weeks after delivery to detect diabetes and pre-diabetes vi CPG Management of Diabetes in Pregnancy 2017 LEVELS OF EVIDENCE Level Study design I Evidence from at least one properly randomised controlled trial II -1 Evidence obtained from well-designed controlled trials without randomisation II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or group II-3 Evidence from multiple time series with or without intervention Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence III Opinions of respected authorities based on clinical experience; descriptive studies and case reports; or reports of expert committees SOURCE: US / CANADIAN PREVENTIVE SERVICES TASK FORCE 2001 FORMULATION OF RECOMMENDATION In line with new development in CPG methodology, the CPG Unit of MaHTAS is in the process of adapting Grading Recommendations, Assessment, Development and Evaluation (GRADE) in its work process The quality of each retrieved evidence and its effect size are carefully assessed/reviewed by the CPG Development Group In formulating the recommendations, overall balances of the following aspects are considered in determining the strength of the recommendations: overall quality of evidence  balance of benefits versus harms  values and preferences  resource implications  equity, feasibility and acceptability vii CPG Management of Diabetes in Pregnancy 2017 GUIDELINES DEVELOPMENT AND OBJECTIVES GUIDELINES DEVELOPMENT The members of the Development Group (DG) for these CPG were from the Ministry of Health (MoH) and Ministry of Higher Education (MoHE) There was active involvement of a multidisciplinary Review Committee (RC) during the process of the CPG development A systematic literature search was carried out using the following electronic databases/platform: Guidelines International Network (G-I-N), Medline via Ovid, Cochrane Database of Systemic Reviews (CDSR) and Pubmed Refer to Appendix for Example of Search Strategy) The inclusion criteria are all diabetes in pregnancy regardless of study design The search was limited to literature published in the last 10 years and on humans and in English In addition, the reference lists of all retrieved literature and guidelines were searched and experts in the field contacted to identify relevant studies All searches were conducted from October 2015 to 21 March 2016 Literature search was repeated for all clinical questions at the end of the CPG development process allowing any relevant papers published before 30 June 2017 to be included Future CPG updates will consider evidence published after this cut-off date The details of the search strategy can be obtained upon request from the CPG Secretariat Reference was also made to other guidelines as listed below:  Ministry of Health Malaysia - CPG on Management of Type Diabetes Mellitus (5th Edition) (December 2015)  National Institute for Clinical Excellence (NICE) - Diabetes in Pregnancy: Management of Diabetes and its Complications from Pre-conception to the Postnatal Period (February 2015)  New Zealand Guideline Group (NZGG) - Screening, Diagnosis and Management of Gestational Diabetes in New Zealand (December 2014) These CPGs were evaluated using the Appraisal of Guidelines for Research and Evaluation (AGREE) II prior to it being used as reference A total of 13 clinical questions were developed under different sections Members of the DG were assigned individual questions within these sections Refer to Appendix for Clinical Questions The DG members met 22 times throughout the development of these guidelines All literatures retrieved were appraised by at least two DG members using Critical Appraisal Skill Programme checklist, presented in evidence tables and further discussed in each DG meetings All statements and recommendations formulated after that were agreed upon by both the DG and RC Where evidence was insufficient, the recommendations were made by consensus of the DG and RC Any differences in opinion are resolved consensually The CPG was based largely on the findings of systematic reviews, meta-analyses and clinical trials, with local practices taken into consideration The literatures used in these guidelines were graded using the US/Canadian Preventive Services Task Force Level of Evidence (2001) while the grading of recommendation was done using the principles of GRADE (refer to the preceding page) The writing of the CPG follows strictly the requirement of AGREE II On completion, the draft CPG was reviewed by external reviewers It was also posted on the MoH Malaysia official website for feedback from any interested parties The draft was finally presented to the Technical Advisory Committee for CPG, and the HTA and CPG Council MoH Malaysia for review and approval Details on the CPG development by MaHTAS can be obtained from Manual on Development and Implementation of Evidence-based Clinical Practice Guidelines published in 2015 (available at :http://www.moh.gov.my/penerbitan/ mymahtas/CPG_MANUAL_MAHTAS.pdf) viii CPG Management of Diabetes in Pregnancy 2017 OBJECTIVES The objectives of the CPG are to provide evidence-based recommendations on diabetes in pregnancy on these aspects: i Screening and diagnosis ii Management (pre-pregnancy, antenatal, intrapartum and post-partum period) CLINICAL QUESTIONS Refer to Appendix TARGET POPULATION Inclusion Criteria i Women with diabetes planning for pregnancy ii Pregnant women at risk of diabetes iii Pregnant women with pre-existing diabetes Exclusion Criteria Pregnant women with secondary causes of diabetes TARGET GROUP/USER This CPG intends to guide those involved in the management of diabetes in pregnancy either in primary or secondary/tertiary care namely: i Medical officers and specialists in public and private practice ii Allied health professionals iii Trainees and medical students iv Patients and their advocates v Professional societies HEALTHCARE SETTINGS Outpatient, inpatient and community settings ix CPG Management of Diabetes in Pregnancy 2017 DEVELOPMENT GROUP Chairperson Dr Nurain Mohd Noor Consultant Endocrinologist Hospital Putrajaya, Putrajaya Members (alphabetical order) Assoc Prof Dr Barakatun Nisak Mohd Yusof Lecturer & Dietician Department of Nutrition and Dietetic Faculty of Medicine and Health Sciences Universiti Putra Malaysia, Selangor Madam Nazatul Syima Idrus Pharmacist & Principal Assistant Director Pharmaceutical Services Division Ministry of Health Malaysia Dr Hanin Farhana Kamaruzaman Senior Principal Assistant Director Health Technology Assessment Section Ministry of Health Malaysia, Putrajaya Dr Noor Lita Adam Consultant Endocrinologist Hospital Tuanku Ja’afar, Negeri Sembilan Dr Hoong Farn Weng Michael Consultant Obstetrician & Gynaecologist Hospital Wanita & Kanak-kanak Sabah Assoc Prof Dr Norasyikin Abdul Wahab Lecturer & Consultant Endocrinologist Faculty of Medicine Universiti Kebangsaan Malaysia, Kuala Lumpur Professor Dr Imelda Balchin Consultant Maternal Fetal Medicine Faculty of Medicine Universiti Malaya, Kuala Lumpur Assoc Prof Dr Norlaila Mustafa Lecturer & Consultant Endocrinologist Faculty of Medicine Universiti Kebangsaan Malaysia, Kuala Lumpur Dr Lili Zuryani Marmuji Family Medicine Specialist Klinik Kesihatan Gunung Rapat, Perak Dr Ranjit Singh Dhalliwal Obstetrician & Gynaecologist Hospital Ampang, Selangor Dr Mastura Ismail Family Medicine Consultant Klinik Kesihatan Seremban 2, Negeri Sembilan Assoc Prof Dr Rohana Abdul Ghani Lecturer & Consultant Endocrinologist Faculty of Medicine Universiti Teknologi MARA, Selangor Dr Mohd Aminuddin Mohd Yusof Head of CPG Unit & Public Health Physician Health Technology Assessment Section Ministry of Health Malaysia, Putrajaya x CPG Management of Diabetes in Pregnancy 2017 90 Nor Azlin MI, Adam R, Sufian SS, et al Safety and tolerability of once or twice daily neutral protamine hagedorn insulin in fasting pregnant women with diabetes during Ramadan J Obstet Gynaecol Res 2010 Feb;37(2):132-7 91 Ismail NA, Olaide Raji H, Abd Wahab N, et al Glycemic Control among Pregnant Diabetic Women on Insulin Who Fasted During Ramadan Iran J Med Sci 2011 Dec;36(4):254-9 29 CPG Management of Diabetes in Pregnancy 2017 Appendix EXAMPLE OF SEARCH STRATEGY Clinical Question: What are the effective and safe screening strategies for diabetes in pregnancy? DIABETES, GESTATIONAL/ (gestational adj1 diabetes mellitus).tw (diabetes adj1 (pregnancy-induced or pregnancy induced or gestational)).tw PREGNANCY IN DIABETICS/ pregnancy in diabet*.tw DIABETES MELLITUS/ diabetes mellitus.tw DM.tw DIABETES MELLITUS, TYPE 1/ 10 Iddm.tw 11 (diabetes mellitus adj1 (insulin-dependent or insulin dependent or insulin-dependent or insulin dependent or type 1)).tw 12 DIABETES MELLITUS, TYPE 2/ 13 Niddm.tw 14 (diabetes mellitus adj1 (non-insulin-dependent or noninsulin-dependent or noninsulin dependent or non insulin dependent or type 2)).tw 15 or or or or 10 or 11 or 12 or 13 or 14 16 PREGNANCY/ 17 pregnanc*.tw 18 16 or 17 19 15 and 18 20 or or or or or 19 21 MASS SCREENING/ 22 screen*.tw 23 (mass adj1 screen*).tw 24 21 or 22 or 23 25 20 and 24 26 limit 25 to (english language and humans and yr="2006 -Current") 30 CPG Management of Diabetes in Pregnancy 2017 Appendix CLINICAL QUESTIONS What are the effective and safe screening strategies for diabetes in pregnancy? What are the methods to diagnose GDM? Are the following interventions effective and safe in pre-existing diabetes? (preconception care and counselling, exercise, contraception, glycaemic/metabolic control, supplementations) Are the following antenatal management effective and safe in non-diabetic pregnant women at risk of gestational diabetes? (lifestyle modification, exercise, medical nutrition therapy [MNT]) Are the following antenatal management effective and safe in pre-existing diabetes and gestational diabetes? (glycaemic/metabolic control, timing and mode of delivery, preeclampsia prophylaxis, MNT, foetal surveillance, screening for congenital malformation) Is oral hypoglycaemic agent effective and safe in pre-existing diabetes and gestational diabetes? Is insulin analogue effective and safe in pre-existing diabetes and gestational diabetes? Are the following intrapartum management (spontaneous vaginal delivery/caesarean section) effective and safe in pre-existing diabetes and gestational diabetes? (blood glucose target, insulin regime) Are the following post-partum management effective and safe in pre-existing diabetes and gestational diabetes? (post-partum glucose monitoring, modification of the treatment, breastfeeding, contraception counseling) 10 What are the effective and safe management of specific conditions in pregnancy? (use of corticosteroids, use of insulin pumps, fasting) 11 What are the effective and safe management for infants of diabetic mothers? 12 What are the indications for referral to secondary/tertiary care? 31 CPG Management of Diabetes in Pregnancy 2017 Appendix CARBOHYDRATE CONTENT OF COMMON MALAYSIAN FOODS Foods Serving Calories (kcal) CHO content (g) Approx CHO exchanges* Cooked rice bowl (159g) 207 48 Roti canai piece (95g) 301 46 Chappati piece (100g) 300 47 Curry mee bowl (450g) 549 55 Fried noodles (mee/mee hoon) plate (30g) 281 41 Bread (white/wholemeal) slice (30g) 70 15 Biscuits, unsweetened pieces (18g) 80 14 Curry puff piece (40g) 128 17 >1 medium (90g) 90 16 ½ cup (98g) 98 64 Full cream milk cup (250ml) 187 18 Low fat milk cup (250ml) 131 12 Skim milk powder tablespoon (28g) 100 16 Condensed milk, sweetened tablespoon (40g) 126 21 1.5 medium (114g) 40 5.3mmol/L Start 0.2units/kg of intermediate-acting insulin at bedtime, increase by units every days until targets are reached 1-hr post-prandial >7.8mmol/L 2-hr post-prandial >6.7mmol/L Start units of short-acting insulin, increase by units every days until targets are reached If pre-prandial short acting insulin dose exceeds 16 units TDS, consider adding 6-10 units intermediate-acting insulin in the morning and titrate accordingly until targets are achieved Estimation of total daily insulin requirement by gestation/trimester Pregnancy gestation Total daily insulin requirement st 0.7 units/kg/day nd 0.8 units/kg/day rd 0.9 units/kg/day trimester trimester trimester Blood Glucose Targets in Pregnancy Timing of Blood Glucose Target Value (mmol/L) Fasting or pre-prandial 5.3 hour after the start of a meal 7.8 hours after the start of a meal 6.7 Sources: Malaysian Endocrine & Metabolic Society and Ministry of Health Malaysia Management of Type Diabetes Mellitus (5th Edition) Kuala Lumpur: MEMS & MOH; 2015 Malaysian Endocrine & Metabolic Society and Ministry of Health Malaysia Practical Guide to Insulin Therapy Kuala Lumpur: MEMS & MOH; 2011 (Available at: http://www.mems.my/file_dir/3308086634dc0e0f9e1c72.pdf) 40 CPG Management of Diabetes in Pregnancy 2017 Appendix INSULIN INFUSION PREPARATION Principles of the infusion: Glucose is infused intravenously at a fixed rate Insulin is administered intravenously at a variable rate CBG is checked hourly and insulin infusion rate adjusted accordingly to maintain target CBG range Women with T1DM need to have some insulin in their system at all times to avoid diabetic ketoacidosis Those with T2DM or GDM may or may not require insulin infusion Insulin requirements decrease after delivery of the placenta Intravenous insulin infusion protocol: Dilute insulin to a concentration of unit/mL Use either 20 units short-acting human insulin (Actrapid) made up to 20 mL with 0.9% saline solution in a 20 mL syringe or 50 units shortacting human insulin made up to 50 mL with 0.9% saline solution in a 50 mL syringe Administer insulin infusion via a syringe pump Based on serum potassium (K+) result, prepare a separate dextrose-potassium chloride (KCl) mixture as below: K+ result Amount of KCl to add to 500 mL of 5% dextrose solution 4.5 mmol/L g (13 mmol) Note: One ampoule of 10 mL KCl 10% contains 13.4 mmol of K+  Initiate IV insulin infusion as detailed in Algorithm C  Maintain a constant infusion of dextrose-KCl over six hours, at a rate 83 mL/hour  The patient would require one dedicated IV cannula with both infusions administered concurrently through infusion pumps, connected via a 3-way stopcock to the IV cannula 41 CPG Management of Diabetes in Pregnancy LIST OF ABBREVIATIONS BG BMI CI CPG CSII DG FA FPG GDM HbA1c HPT HR IAsp IOL IV LGA MaHTAS NICE NICU NPH OGTT OHA PG PIH RC RCT RR SC SGA SMBG T1DM T2DM 2HPP Blood glucose Body mass index Confidence interval Clinical practice guidelines Continuous subcutaneous insulin infusion Development Group Folic acid Fasting plasma glucose Gestational diabetes mellitus Glycosylated haemoglobin hypertension Hazard ratio Insulin aspart Induction of labour Intravenous Large for gestational age Malaysian Health Technology Assessment Section National Institute for Health and Care Excellence Neonatal intensive care unit Neutral protamine Hagedorn Oral glucose tolerance test Oral hypoglycaemic agent Plasma glucose Pregnancy-induced hypertension Review Committee Randomised controlled trial Relative risk / risk ratio Subcutaneous Small for gestational age Self-monitoring blood glucose Type diabetes mellitus Type diabetes mellitus 2-hour post-prandial 42 2017 CPG Management of Diabetes in Pregnancy 2017 ACKNOWLEDGEMENT The members of CPG DG would like to express their gratitude and appreciation to the following for their contributions:  Panel of external reviewers who reviewed the draft  Technical Advisory Committee of CPG for their valuable input and feedback  Madam Rosnani Abdul Latip, Information Specialist MaHTAS  Ms Noormah Darus, Pharmacist of MaHTAS  Dr Matthew Chong Hon Loon, Neonatologist, Hospital Putrajaya  CPG Technical Advisory Committee for their valuable input and feedback  All those who have contributed directly or indirectly to the development of the CPG DISCLOSURE STATEMENT The panel members of both Development Group and Review Committee had completed disclosure forms None held shares in pharmaceutical firms or acts as consultants to such firms (Details are available upon request from the CPG Secretariat) SOURCE OF FUNDING The development of the CPG on Management of Diabetes in Pregnancy was supported financially by Ministry of Health Malaysia 43