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Diabetes in pregnancy
Management of diabetes and its complications
from preconception to the postnatal periodNICE guideline NG3
Methods, evidence and recommendations
Wednesday February 25th, 2015
FinalCommissioned by the National Institute for
Health and Care Excellence
December 2020: NICE's original guidance on diabetes in pregnancy was published in 2015. It was updated in 2018 and 2020. See the NICE website for the guideline recommendations and the evidence reviews for the 2020 updates. This document preserves evidence reviews and committee discussions for areas of the guideline that were not updated in 2018 or 2020. © 2015 National Collaborating Centre for Women's and Children's HealthDiabetes in pregnancy
Contents
Disclaimer
Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and/or their guardian or carer.Copyright
© 2015 National Collaborating Centre for Women's and Children's HealthFunding
Registered charity no. 213280
Diabetes in pregnancy
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 4Contents
1 Introduction ........................................................................................................................... 36
1.1 2008 Guideline ............................................................................................................... 36
1.1.1 Diabetes in pregnancy ........................................................................................ 36
1.1.2 Aim of the guideline ............................................................................................ 37
1.1.3 Areas outside the remit of the guideline .............................................................. 37
1.1.4 For whom is the guideline intended? ................................................................... 37
1.1.5 Other relevant documents ................................................................................... 38
1.1.6 Other relevant documents ................................................................................... 39
1.1.7 Guideline methodology ....................................................................................... 39
1.1.8 Schedule for updating the guideline .................................................................... 45
1.1.9 Stakeholder involvement in the guideline development process .......................... 45
1.2 2015 guideline update development methodology
1.2.1 Introduction
1.2.2 Developing review questions and protocols and identifying evidence .................. 46
1.2.3 Reviewing and synthesising evidence ................................................................. 46
1.2.4 Assessing cost effectiveness .............................................................................. 49
1.2.5 Evidence to recommendations ............................................................................ 50
1.2.6 Stakeholder involvement ..................................................................................... 51
1.2.7 Specific considerations for this guideline ............................................................. 51
1.3 Schedule for updating the 2015 guideline ....................................................................... 52
1.4 Explaining the changes in the partial update of the 2015 guideline ................................. 52
2 Summary of recommendations and care pathway .............................................................. 53
2.1.1 Intrapartum care .................................................................................................. 55
2.1.2 Postnatal care ..................................................................................................... 55
2.1 Key research recommendations ..................................................................................... 55
2.2.1 Preconception care for women with diabetes: insulin pump therapy and continuous
glucose monitoring .............................................................................................. 55
2.2.2 Testing for gestational diabetes .......................................................................... 55
2.2.3 Barriers to achieving blood glucose targets before and during pregnancy ........... 56
2.2.4 Risk of fetal death for women with diabetes ........................................................ 56
2.2.5 Postnatal treatment for women diagnosed with gestational diabetes ................... 56
2.2 Recommendations ......................................................................................................... 57
2.3 Care pathway ................................................................................................................. 61
3 Preconception care ............................................................................................................... 62
3.1 Outcomes and risks for woman and baby ....................................................................... 62
3.1.1 Description of the evidence ................................................................................. 62
3.1.2 How diabetes affects pregnancy ......................................................................... 62
3.1.3 How pregnancy affects diabetes ......................................................................... 63
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 53.1.4 Ethnicity .............................................................................................................. 63
3.1.5 Evidence statement ............................................................................................ 63
3.1.6 Existing guidance ................................................................................................ 64
3.1.7 From evidence to recommendations ................................................................... 64
3.1.8 Recommendations .............................................................................................. 64
3.1.9 Research recommendations ............................................................................... 64
3.2 The importance of planning pregnancy and the role of contraception ............................. 64
3.2.1 General advice .................................................................................................... 64
3.2.2 Description of the evidence ................................................................................. 64
3.2.3 Evidence statement ............................................................................................ 67
3.2.4 From evidence to recommendations ................................................................... 67
3.2.5 Recommendations .............................................................................................. 68
3.3 Oral contraception .......................................................................................................... 68
3.3.1 Review questions ................................................................................................ 68
3.3.2 Introduction ......................................................................................................... 68
3.3.3 Description of included studies ............................................................................ 68
3.3.4 Evidence profiles ................................................................................................. 70
3.3.5 Evidence statements ......................................................................................... 120
3.3.6 Health economics profile ................................................................................... 131
3.3.7 Evidence to recommendations .......................................................................... 131
3.3.8 Consideration of health benefits and resource uses .......................................... 132
3.3.9 Quality of evidence ............................................................................................ 132
3.3.10 Other considerations ......................................................................................... 133
3.3.11 Key conclusions ................................................................................................ 134
3.3.12 Recommendations ............................................................................................ 134
3.3.13 Research recommendations ............................................................................. 134
3.4 Diet, dietary supplements, body weight and exercise .................................................... 136
3.4.1 Description of the evidence ............................................................................... 136
3.4.2 Existing guidance .............................................................................................. 138
3.4.3 Evidence statement .......................................................................................... 139
3.4.4 From evidence to recommendations ................................................................. 139
3.4.5 Recommendations ............................................................................................ 139
3.4.6 Research recommendations ............................................................................. 139
3.5 Monitoring blood glucose and ketones in the preconception period .............................. 139
3.5.1 Blood glucose monitoring .................................................................................. 139
3.5.2 Ketone monitoring ............................................................................................. 141
3.6 Target blood glucose values for women with type 1 or type 2 diabetes planning pregnancy
..................................................................................................................................... 145
3.6.1 Review question ................................................................................................ 145
3.6.2 Introduction ....................................................................................................... 145
3.6.3 Description of included studies .......................................................................... 145
3.6.4 Health economics profile ................................................................................... 145
3.6.5 Evidence to recommendations .......................................................................... 145
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 63.6.6 Key conclusions ................................................................................................ 146
3.6.7 Recommendations ............................................................................................ 147
3.6.8 Research recommendations ............................................................................. 147
3.7 Target HbA1c values for women with type 1 or type 2 diabetes planning pregnancy .... 149
3.7.1 Review question ................................................................................................ 149
3.7.2 Introduction ....................................................................................................... 149
3.7.3 Description of included studies .......................................................................... 150
3.7.4 Evidence profile ................................................................................................ 150
3.7.5 Evidence statements ......................................................................................... 155
3.7.6 Health economics profile ................................................................................... 156
3.7.7 Evidence to recommendations .......................................................................... 156
3.7.8 Key conclusions ................................................................................................ 157
3.7.9 Recommendations ............................................................................................ 157
3.8 Safety of medicines for diabetes before and during pregnancy ..................................... 158
3.8.1 Description of the evidence ............................................................................... 158
3.8.2 Existing guidance .............................................................................................. 164
3.8.3 Evidence statement .......................................................................................... 164
3.8.4 From evidence to recommendations ................................................................. 164
3.8.5 Recommendations ............................................................................................ 164
3.8.6 Research recommendations ............................................................................. 164
3.9 Safety of medicines for diabetic complications before and during pregnancy ............... 164
3.9.1 Description of the evidence ............................................................................... 165
3.9.2 Evidence statement .......................................................................................... 168
3.9.3 From evidence to recommendations ................................................................. 168
3.9.4 Recommendations ............................................................................................ 168
3.10 Removing barriers to the uptake of preconception care and when to offer information . 168
3.10.1 Description of the evidence ............................................................................... 169
3.10.2 From evidence to recommendations ................................................................. 172
3.10.3 Recommendations ............................................................................................ 172
3.10.4 Evidence statement .......................................................................................... 172
3.11 Cost-effectiveness of self-management programmes ................................................... 174
3.11.1 From evidence to recommendations ................................................................. 174
3.12 Recommendations ....................................................................................................... 175
3.12.1 Research recommendations ............................................................................. 175
3.13 Retinal assessment in the preconception period ........................................................... 176
3.13.1 Evidence ........................................................................................................... 176
3.13.2 Recommendations ............................................................................................ 176
3.13.3 Research recommendations ............................................................................. 176
3.14 Renal assessment in the preconception period ............................................................ 176
3.14.1 Evidence ........................................................................................................... 176
3.14.2 Recommendations ............................................................................................ 176
3.14.3 Research recommendations ............................................................................. 176
4 Gestational diabetes ........................................................................................................... 177
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 74.1 Introduction .................................................................................................................. 177
4.2 Risk factors for gestational diabetes ............................................................................. 178
4.2.1 Description of the evidence ............................................................................... 178
4.2.2 Evidence statement .......................................................................................... 181
4.2.3 From evidence to recommendations ................................................................. 181
4.2.4 Recommendations ............................................................................................ 182
4.3 Screening for gestational diabetes................................................................................ 182
4.3.1 Introduction ....................................................................................................... 182
4.3.2 Screening for gestational diabetes in the first trimester ..................................... 182
4.3.3 Screening for gestational diabetes in the second trimester ................................ 229
4.4 Diagnostic criteria for gestational diabetes ................................................................... 256
4.4.1 Review question ................................................................................................ 256
4.4.2 Introduction ....................................................................................................... 256
4.4.3 Methods ............................................................................................................ 257
4.4.4 Description of included studies .......................................................................... 257
4.4.5 Evidence profile ................................................................................................ 258
4.4.6 Evidence statements ......................................................................................... 262
4.4.7 Health economics profile ................................................................................... 263
4.4.8 Evidence to recommendations .......................................................................... 263
4.4.9 Key conclusions ................................................................................................ 267
4.4.10 Recommendations ............................................................................................ 268
4.5 Interventions in women with gestational diabetes ......................................................... 268
4.5.1 Information for women with gestational diabetes ............................................... 268
4.5.2 Review question ................................................................................................ 268
4.5.3 Introduction ....................................................................................................... 268
4.5.4 Description of included studies .......................................................................... 269
4.5.6 Evidence statements ......................................................................................... 309
4.5.7 Health economics profile ................................................................................... 315
4.5.8 Evidence to recommendations .......................................................................... 316
4.5.9 Key conclusions ................................................................................................ 321
4.5.10 Recommendations ............................................................................................ 322
4.5.11 Research recommendations ............................................................................. 325
5 Antenatal care ...................................................................................................................... 328
5.1 Monitoring blood glucose and ketones during pregnancy ............................................. 328
5.1.1 Blood glucose monitoring .................................................................................. 328
5.1.2 Ketone monitoring ............................................................................................. 349
5.2 Target blood glucose values for women with type 1, type 2 or gestational diabetes during
pregnancy .................................................................................................................... 353
5.2.1 Review question ................................................................................................ 353
5.2.2 Introduction ....................................................................................................... 354
5.2.3 Description of included studies .......................................................................... 354
5.2.4 Evidence profile ................................................................................................ 355
5.2.5 Evidence statements ......................................................................................... 363
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 85.2.6 Health economics profile ................................................................................... 364
5.2.7 Evidence to recommendations .......................................................................... 364
5.2.8 Recommendations ............................................................................................ 365
5.2.9 Research recommendations ............................................................................. 365
5.3 HbA1c values for women with type 1, type 2 or gestational diabetes during pregnancy
monitoring and target values ......................................................................................... 367
5.3.1 Monitoring ......................................................................................................... 367
5.3.2 Target values .................................................................................................... 370
5.4 Management of diabetes during pregnancy .................................................................. 380
5.4.1 Description of the evidence ............................................................................... 380
5.4.2 Existing guidance .............................................................................................. 382
5.4.3 Evidence statement........................................................................................... 382
5.4.4 From evidence to recommendations ................................................................. 382
5.4.5 Recommendations ............................................................................................ 383
5.4.6 Research recommendations ............................................................................. 383
5.5 Continuous glucose monitoring .................................................................................... 384
5.5 Recommendations ............................................................................................ 390
5.5.1 Research recommendations ............................................................................. 390
5.6 Retinal assessment during pregnancy .......................................................................... 390
5.6.1 Description of the evidence ............................................................................... 391
5.6.2 Current practice ................................................................................................ 395
5.6.3 Existing guidance .............................................................................................. 396
5.6.4 Evidence statement .......................................................................................... 396
5.6.5 From evidence to recommendations ................................................................. 396
5.6.6 Recommendations ............................................................................................ 397
5.6.7 Research recommendations ............................................................................. 397
5.7 Renal assessment during pregnancy ............................................................................ 397
5.7.1 Description of the evidence ............................................................................... 398
5.7.2 Current practice ................................................................................................ 399
5.7.3 Existing guidance .............................................................................................. 399
5.7.4 Evidence statement .......................................................................................... 400
5.7.5 From evidence to recommendations ................................................................. 400
5.7.6 Current practice ................................................................................................ 401
5.7.7 Existing guidance .............................................................................................. 401
5.7.8 Evidence statement .......................................................................................... 401
5.7.9 From evidence to recommendations ................................................................. 402
5.7.10 Recommendations ............................................................................................ 402
5.7.11 Research recommendations ............................................................................. 402
5.8 Screening for congenital malformations ........................................................................ 403
5.8.1 Description of the evidence ............................................................................... 403
5.8.2 First-trimester screening for chromosomal anomalies ....................................... 405
5.8.3 Second-trimester ultrasound screening for structural anomalies ....................... 406
5.8.4 Evidence statement .......................................................................................... 407
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 95.8.5 Cost-effectiveness ............................................................................................ 407
5.8.6 Existing guidance .............................................................................................. 407
5.8.7 From evidence to recommendations ................................................................. 408
5.8.8 Recommendations ............................................................................................ 408
5.8.9 Research recommendations ............................................................................. 408
5.9 Monitoring fetal growth and wellbeing ........................................................................... 409
5.9.1 Description of the evidence ............................................................................... 409
5.9.2 Evidence statement .......................................................................................... 413
5.9.3 Cost-effectiveness ............................................................................................ 413
5.9.4 Existing guidance .............................................................................................. 414
5.9.5 From evidence to recommendations ................................................................. 414
5.9.6 Recommendations ............................................................................................ 414
5.9.7 Research recommendations ............................................................................. 414
5.10 Timetable of antenatal appointments ............................................................................ 415
5.10.1 Description of the evidence ............................................................................... 415
5.10.2 From evidence to recommendations ................................................................. 416
5.10.3 Recommendations ............................................................................................ 422
5.11 Specialist teams ........................................................................................................... 422
5.11.1 Review question ................................................................................................ 422
5.11.2 Introduction ....................................................................................................... 422
5.11.3 Description of included studies .......................................................................... 422
5.11.4 Evidence profile ................................................................................................ 422
5.11.5 Evidence statements ......................................................................................... 430
5.11.6 Health economics profile ................................................................................... 430
5.11.7 Evidence to recommendations .......................................................................... 431
5.11.8 Key conclusions ................................................................................................ 432
5.11.9 Recommendations ............................................................................................ 432
5.12 Preterm labour in women with diabetes ........................................................................ 435
5.12.1 Description of the evidence ............................................................................... 435
5.12.2 Incidence of preterm birth .................................................................................. 435
5.12.3 Evidence statement .......................................................................................... 436
5.12.4 From evidence to recommendations ................................................................. 436
5.12.5 Recommendations ............................................................................................ 436
5.12.6 Research recommendations ............................................................................. 436
6 Intrapartum care .................................................................................................................. 438
6.1 Timing and mode of birth .............................................................................................. 438
6.1.1 Mode of birth ..................................................................................................... 438
6.1.2 Timing of birth ...................................................................................................... 443
6.2 Analgesia and anaesthesia ........................................................................................... 473
6.2.1 Description of the evidence ............................................................................... 473
6.2.2 Existing guidance .............................................................................................. 475
6.2.3 Evidence statement .......................................................................................... 475
6.2.4 From evidence to recommendations ................................................................. 475
Diabetes in pregnancy
Contents
© 2015 National Collaborating Centre for Women's and Children's Health 106.2.5 Recommendations ............................................................................................ 476
6.2.6 Research recommendations ............................................................................. 476
6.3 Glycaemic control during labour and birth ..................................................................... 476
6.3.1 Description of the evidence ............................................................................... 476
6.3.2 Evidence statement .......................................................................................... 480
6.3.3 From evidence to recommendations ................................................................. 480
6.3.4 Recommendations ............................................................................................ 480
6.3.5 Research recommendations ............................................................................. 480
7 Neonatal care ....................................................................................................................... 482
7.1 Initial assessment and criteria for admission to intensive or special care ...................... 482
7.1.1 Description of the evidence ............................................................................... 482
7.1.2 Criteria for admission to intensive/special care .................................................. 484
7.1.3 Current practice ................................................................................................ 486
7.1.4 Existing guidance .............................................................................................. 487
7.1.5 Evidence statement .......................................................................................... 487
7.1.6 From evidence to recommendations ................................................................. 488
7.1.7 Recommendations ............................................................................................ 488
7.1.8 Research recommendations ............................................................................. 488
7.2 Prevention and assessment of neonatal hypoglycaemia............................................... 488
7.2.1 Description of the evidence ............................................................................... 489
7.2.2 Existing guidance .............................................................................................. 494
7.2.3 Evidence statement .......................................................................................... 494
7.2.4 From evidence to recommendations ................................................................. 495
7.2.5 Recommendations ............................................................................................ 496
7.2.6 Research recommendations ............................................................................. 496
8 Postnatal care ...................................................................................................................... 497
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