National Pregnancy in Diabetes Audit Report 2013 - NHS Digital [PDF]

National Pregnancy in Diabetes Audit Report 2013 England, Wales and the Isle of Man

Prepared in collaboration with: The Healthcare Quality Improvement Partnership (HQIP). The National Pregnancy in Diabetes Audit is commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit Programme (NCA). HQIP is led by a consortium of the Academy of Medical Royal Colleges, the Royal College of Nursing and National Voices. Its aim is to promote quality improvement, and in particular to increase the impact that clinical audit has on healthcare quality in England and Wales. HQIP holds the contract to manage and develop the NCA Programme, comprising more than 30 clinical audits that cover care provided to people with a wide range of medical, surgical and mental health conditions. The programme is funded by NHS England, the Welsh Government and, with some individual audits, also funded by the Health Department of the Scottish Government, DHSSPS Northern Ireland and the Channel Islands. The Health and Social Care Information Centre (HSCIC) is the trusted source of authoritative data and information relating to health and care. The HSCIC managed the publication of the 2013 annual report.

Diabetes UK is the largest organisation in the UK working for people with diabetes, funding research, campaigning and helping people live with the condition.

The National Pregnancy in Diabetes Audit is supported by The national cardiovascular intelligence network (NCVIN) is a partnership of leading national cardiovascular organisations which analyses information and data and turns it into meaningful timely health intelligence for commissioners, policy makers, clinicians and health professionals to improve services and outcomes.

National Pregnancy in Diabetes Audit 2013 National Summary

Key findings about the quality of care and outcomes for women with diabetes who become pregnant in England, Wales and Isle of Man Report for the audit period 2013 Copyright © 2014, Health and Social Care Information Centre. All rights reserved.

3

Contents Acknowledgements

5

Foreword

6

Key findings

7

Key messages from the audit

7

Recommendations

8

Introduction

9

Methodology

10

Participation

11

Characteristics of women included in the audit

14

Type of diabetes

14

Age and body mass index (BMI) of women

14

Ethnicity and deprivation

15

Were women adequately prepared for pregnancy?

16

Folic acid supplement

16

HbA1c control

16

Diabetes treatment regimen prior to pregnancy

17

Care in pregnancy and HbA1c control

19

Gestation at first contact with specialist antenatal diabetes team

19

HbA1c control

19

Were adverse fetal/infant outcomes minimised?

21

Pregnancy outcomes

21

Babies

23

Discussion

26

Were women adequately prepared for pregnancy?

26

Minimising risk during pregnancy

26

Pregnancy outcomes

27

Conclusions

27

Further information

28

References

29

Appendix 1

30

Characteristics of women included in the audit Appendix 2 Confidence intervals Appendix 3 Organisations submitting data to the audit

Copyright © 2014, Health and Social Care Information Centre. All rights reserved.

30 31 31 32 32

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Acknowledgements The National Pregnancy in Diabetes (NPID) Audit is part of the National Diabetes Audit (NDA) programme, and is commissioned by The Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit programme (NCA). The NDA is managed by the Health and Social Care Information Centre (HSCIC) in partnership with Diabetes UK and is supported by Public Health England (PHE). Throughout the development of the audit there has been invaluable support from patients and their representatives, clinical staff and other health professionals. In particular, we would like to express our thanks to all the patients, clinical staff and commissioners for contributing to this valuable piece of work. Development and delivery of the NPID audit is guided by a multi-professional national group of obstetricians, midwives, diabetes specialist nurses, diabetologists, public health physicians, and service user representatives chaired by Dr Nick Lewis-Barned. Our thanks also go to Catherine Sylvester and Paula Curnow at the HSCIC and Ruth Bell and Danielle Crowder at the Regional Maternity Survey Office at Newcastle University for producing the analysis within this report. The NPID Advisory Group members include: Nick Lewis-Barned Consultant Physician, Northumbria Healthcare NHS Trust (Chair) Bob Young Specialist Clinical Lead, National Diabetes Audit Ruth Bell Associate Director, Regional Maternity Survey Office, Newcastle University Richard Holt Professor and Honorary Consultant in Diabetes and Endocrinology, University of Southampton Emma Adams NPID Audit Manager, Health and Social Care Information Centre (HSCIC)


Laura Fargher NDA Engagement Manager, Diabetes UK Bob Fraser Honorary Reader in Obstetrics and Gynaecology, University of Sheffield Catherine Sylvester Analyst, Health and Social Care Information Centre (HSCIC) Shaida Tanweer Audit Coordinator, Health and Social Care Information Centre (HSCIC) Mike Maresh Consultant Obstetrician, St Mary’s Hospital, Manchester Emily Angiolini Patient representative Jane Hawdon Consultant Neonatologist, University College London Hospitals Naomi Holman Head of Health Intelligence, National Cardiovascular Intelligence Network, Public Health England Rosemary Temple Consultant Physician in Diabetes and Endocrinology Di Todd Diabetes Specialist Midwife, University Hospitals Leicester NHS Trust Helen Murphy Honorary Consultant/Senior Research Associate, University of Cambridge Margery Morgan Consultant Obstetrician and Gynaecologist, Singleton Hospital, Swansea Gillian Peace Patient representative

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Foreword The hazards of pregnancy in women with diabetes have long been recognised. The reductions in risk achievable by pregnancy preparation and multidisciplinary antenatal and obstetric care have been embedded in national guidance (National Service Framework (NSF) for Diabetes1, National Service Framework (NSF) for Diabetes in Wales2, National Institute for Health and Clinical Excellence (NICE) Clinical Guidelines3 and NICE Quality Standards for Diabetes4). We welcome, therefore, this new module of the National Diabetes Audit (NDA), the National Pregnancy in Diabetes (NPID) audit. For the first time this offers a mechanism to measure implementation of national guidance about pregnancy management in women with diabetes and to monitor adverse outcomes. It is encouraging that in the first year 128 services participated in the audit and that more have signed up since. The outcome data confirm the continuing adverse impact of pre-existing diabetes on pregnancy with high levels of congenital anomalies, stillbirths, neonatal deaths and babies that are large for gestational age. The data also show that there are substantial opportunities for improvement through, for example, enabling more women to achieve lower glucose levels before conception and throughout pregnancy and ensuring that all women with diabetes contemplating pregnancy are taking folic acid supplements. We are grateful to the NDA team and all the first year participants for their efforts in establishing this important national audit. We look forward to witnessing the improvement programmes that will follow on from publication of the results and to the reductions in poor pregnancy outcomes that will ensue.

Professor Jonathan Valabhji MD FRCP National Clinical Director for Obesity and Diabetes, NHS England

Dr Catherine Calderwood MA MRCOG FRCP Edin National Clinical Director for Maternity and Women's Health, NHS England

Consultant Physician, Diabetologist and Endocrinologist, Imperial College Healthcare NHS Trust Adjunct Professor of Diabetes and Endocrinology, Imperial College London


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Key findings The National Pregnancy in Diabetes Audit Report 2013 is the first annual national picture of the quality of care and outcomes for women with diabetes who become pregnant. This will matter to the public, especially those with diabetes, to service providers, planners and policy makers, as well as to local teams delivering care. It forms a foundation for quality improvement in this important area.

Key messages from the audit • Information on over 1,700 pregnancies in women with diabetes across 128 participating organisations was submitted to the first year of the audit. • The audit confirms the growing proportion of pregnancies in women with Type 2 diabetes (44.9 per cent) when compared with the CEMACH5 survey 10 years ago (27.3 per cent). • Only 33.0 per cent of women were taking the recommended 5mg dose of folic acid prior to pregnancy, and a further 7.1 per cent were taking 400mcg of folic acid. • Folic acid use was higher among women with Type 1 diabetes, with 42.6 per cent of women taking the 5mg dose, and a further 4.6 per cent taking 400mcg. Among women with Type 2 diabetes, only 24.7 per cent were taking the 5mg dose, with a further 9.7 per cent taking 400mcg. • Only a minority of women had HbA1c measurements in the first trimester of pregnancy below the NICE target of 43 mmol/mol (6.1%) (5.1 per cent of women with Type 1 diabetes and 18.5 per cent of women with Type 2 diabetes).

• Women who had a stillbirth or neonatal death (without a congenital anomaly) were more likely to have higher HbA1c measurements in late pregnancy (only 39.1 per cent had a measurement below 53 mmol/mol (7.0%), compared with 70.8 per cent of women who had a live birth that was alive at 28 days post delivery). • Women with diabetes continue to have babies that are large for gestational age i.e. above the 90th birthweight centile (46.0 per cent of babies born to women with Type 1 diabetes; 23.4 per cent of babies born to women with Type 2 diabetes). A substantial proportion of babies were above the 97.7th birthweight centile (28.6 per cent of babies whose mother had Type 1 diabetes, 12.5 per cent of babies whose mother had Type 2 diabetes). • 70.3 per cent of babies did not require intensive or specialist neonatal care, a significant improvement compared with the CEMACH survey 10 years previously (when only 42.8 per cent of babies were cared for on a postnatal ward with their mother). Over the next few years the audit will encourage all organisations caring for women with diabetes who become pregnant to participate to support the measurement of key indicators of performance and outcomes. Participating organisations are encouraged to use the findings in this report alongside regional analysis to help them identify key areas for improvement and to support the quality improvement cycle.

• Nearly 1 in 10 women with Type 2 diabetes (9.4 per cent) were taking blood glucose medications that may be harmful in pregnancy at their last menstrual period.


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Recommendations In view of the extremely high risk nature of pregnancies in women with diabetes who become pregnant, renewed commitments are needed by every diabetes and maternity service: • to become part of the measurement process • and to develop local improvement initiatives to reduce pregnancy risk. Specifically, units should: • urgently develop a strategic focus on improving preparation for pregnancy, including engaging with primary care teams locally to raise awareness and enhance pregnancy planning • develop plans to incorporate training about pregnancy into patient education programmes especially for women with Type 2 diabetes • focus on improving glycaemic control during pregnancy for women with both Type 1 and Type 2 diabetes to avoid late adverse fetal outcomes. This will require cooperation between local service providers and a clear plan for change. It is also clear that close collaboration and a coordinated approach are needed from commissioners, healthcare providers and professional bodies to work across the system if outcomes are to be improved.


8

Introduction The National Pregnancy in Diabetes (NPID) Audit is part of the National Diabetes Audit (NDA) programme, and is commissioned by The Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit programme (NCA). The NDA is managed by the Health and Social Care Information Centre (HSCIC) in partnership with Diabetes UK and is supported by Public Health England (PHE). This report is the first of a planned annual rolling audit of the care and outcomes for women with diabetes who become pregnant. The inclusion of over 1700 pregnancies from 128 participating organisations across England, Wales and the Isle of Man is a huge achievement. It is testimony to the hard work and commitment of local teams and the participating organisations and to the passion and value that is placed on this by professionals and women with diabetes. The audit is a measurement system to support improvement in the quality of care for women with diabetes who are pregnant or planning pregnancy and seeks to address the three key questions: • Were women adequately prepared for pregnancy? • Were adverse maternal outcomes minimised? • Were adverse fetal/infant outcomes minimised? The audit measures relate to national standards (National Institute for Health and Clinical Excellence (NICE) Clinical Guideline (CG) 633, NICE Quality Standard (QS) for Diabetes 64). The NICE guideline on diabetes in pregnancy (CG63)3 contains recommendations for the management of diabetes and its complications in women of child bearing age, planning pregnancy or already pregnant. (This guideline is being updated, and is currently under consultation with stakeholders prior to publication of the updated guideline in February 2015.)

i

The results of the audit will be used to monitor the quality of care provided for women with diabetes who become pregnant against the NICE guideline. Two factors have limited the scope of the audit in its first year. Firstly, access to retinopathy screening data has proved difficult for many centres; this is now being addressed by NHS Diabetes Eye Screening. Secondly, it has not been possible to link data about hospital admissions during pregnancy for this report because of the temporary moratorium on Hospital Episode Statistics data use during the review of data release processes within the HSCICi. These limitations mean that the second audit question regarding adverse maternal outcomes is not addressed in this report. The linked data is expected to be available for future reports – in addition to adverse maternal outcomes, the linked data will provide information on the mode of delivery and onset of labour. This report provides national aggregate reporting. Most key adverse measures are too infrequent to be reported annually at individual unit level, so local information will be published at regional level. It is hoped that this will stimulate collaboration and learning that can be shared and generalised. This report presents the findings of the 2013 audit from participating organisations reporting on women with diabetes who became pregnant where the first specialist antenatal clinic contact during their pregnancy was on or after 1st July 2012 and where their pregnancy was completed between 1st January 2013 and 31st December 2013. Pregnancies recorded where the first contact with the specialist antenatal team was after 1st July 2012 and the pregnancy ended before 31st December 2012 are not included. It is supported by regional reports that can be downloaded from the audit website at www.hscic.gov.uk/npid

www.hscic.gov.uk/datareview


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Methodology The National Pregnancy in Diabetes (NPID) Audit is an ongoing data collection managed by hospital teams in England, Wales and the Isle of Man. The audit collects demographic and clinical information on women with diabetes who become pregnant. Participating organisations (outside the North East of England) were asked to collect the required information on all eligible women where the first contact with specialist antenatal services after their last menstrual period was on or after 1st July 2012. A copy of the data collection form can be found on the audit website at www.hscic.gov.uk/npid

For the 2013 NPID audit, these data items were obtained from the NDA collections for 2012-13 and 2011-12. It has not been possible to obtain these data items from the NDA for 164 pregnancy records from the NPID audit (9.6 per cent of all pregnancies recorded in the NPID audit for 2013). Possible reasons for this include: • The woman was not registered at a GP practice or specialist diabetes service at the relevant time • The GP practice or specialist diabetes service where the woman was registered had opted not to submit data to the NDA

Patients were provided with an information leaflet outlining the audit and the process for collecting information, and explicit patient consent was obtained prior to data being submitted to the audit. Where the patient did not provide consent their information was not submitted to the audit.

• The woman had asked the GP practice or specialist diabetes service to exclude her data from their NDA data submission

Participating organisations added the data they collected to the audit database using the web based NPID online submission tool.

There were also a small number of NDA records where the woman’s diabetes type was recorded as ‘Not specified’.

The deadline for submissions for inclusion in this report was 7th February 2014.

In each of the tables in this report, the ‘All pregnancies’ or ‘All babies’ column includes these pregnancies with an unknown diabetes type.

Following data quality checks, submitting organisations had an opportunity to update or amend their data, and this report is based on the data recorded at 8th June 2014. This data was cleaned to remove inconsistent date entries and related items prior to analysis. For women in the North East of England, the information collected in the NPID audit is already collected in the Northern Diabetes in Pregnancy (NorDIP) Survey6 managed by the Regional Maternity Service Office on behalf of Public Health England. To reduce the burden of data submission, this report uses data collected in the NorDIP survey and provided to the HSCIC on an aggregated basis. For users of the NPID online submission tool, the burden of data submission was minimised by obtaining the following data for the women included in the audit from the National Diabetes Audit (NDA):

• The woman was diagnosed with diabetes after 31 March 2013.

Although the majority of the questions on the data collection form and online submission tool were mandatory, there were some non-mandatory questions, and also some missing data in the NorDIP survey. Some mandatory items for a small number of records were treated as missing data following the data cleaning. The analysis in each table and chart in this report uses as much of the submitted data as possible by including all records where the relevant data item has been completed, even where there is missing information elsewhere in that record. In each table, N shows the number of records in the audit for which a response has been entered or obtained for the relevant data item. For example, in Table 5 ‘Maternal age at completion of pregnancy’ was available for 1,703 of the 1,704 pregnancies included in the audit, while ‘Age at diagnosis’ was available for 1,413 pregnancies.

• Diabetes type • Year of diabetes diagnosis • Ethnicity • Indices of Multiple Deprivation score for residence.


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Participation The 2013 audit received completed pregnancy data from 128 submitting organisations in England, Wales and the Isle of Man incorporating data on the clinical care of 1,697 women.

Figure 1 shows the geographical distribution of organisations that submitted audit data for 2013, including organisations that submitted completed pregnancy records using the online submission tool, organisations that have started to submit records using the online submission tool but did not record any completed pregnancies in the audit period, and organisations in North East England that provided data via the Northern Diabetes in Pregnancy Survey (NorDIP)6.

Figure 1 Participating organisations

Submitted completed NPID records using online system Began submitting partial data using online system Provided data via the NorDIP survey London

Ordnance Survey Licence Number 100044406. © Crown copyright and database right, 2014

Organisations chose whether to participate in the NPID audit at hospital level or at Trust/Local Health Board level. Table 1 shows the number of organisations participating in the audit during 2013.

ii

The data collection is continuous; organisations were able to start participating part way through 2013, the first year of the NPID audit. Registration for the audit is ongoing; a further threeii organisations have begun submitting data in 2014.

As at 6 August 2014.


11

Table 1 Organisations submitting data to the audit, 2013 Number of organisations submitting completed pregnancy records

Number of organisations starting to record pregnancy data

Total number of participating organisations

124

5

129

4

0

4

128

5

133

England (including the Isle of Man) Wales England and Wales

The type of diabetes was identified for 88.9 per cent of women included in the audit. (Where the diabetes type is not known, this is because either the woman’s details were not recorded in the NDA for 2011-12 or 2012-13, or her diabetes type was recorded as ‘Not specified’.) Among the women for whom their diabetes type was recorded, 54.3 per cent had Type 1 diabetes, and 45.0 per cent had Type 2 diabetes. Table 2 Women, pregnancies and babies included in the audit, 2013

Women

All women

Women with Type 1 diabetes

Women with Type 2 diabetes

Other women with diabetesa

1,697

819

678

200

Pregnancies

1,704b

823

680

201

Total pregnancy outcomesc

1,731d

832

698

201

Pregnancies ongoing after 24 completed weeks of gestation

1,578

769

631

178

Live births after 24 completed weeks of gestation

1,576

767

638

171

26

11

9

6

1,602

778

647

177

Stillbirths Total infants born after 24 completed weeks of gestation Live births delivering before 24 completed weeks of gestation Live births with gestation unknown Total registered births

1

0

1

0

11

4

5

2

1,614

782

653

179

Women recorded as having maturity onset diabetes of the young (MODY), ‘Other’ diabetes types or whose diabetes type was not recorded. b Seven women had two pregnancies recorded within the audit period. c Total pregnancy outcomes includes live births, stillbirths, terminations of pregnancy and miscarriages. Each fetus/baby is counted, so a twin pregnancy is counted as two outcomes. d There were 27 twin pregnancies recorded in the audit. a

Pregnancies recorded in the audit accounted for an estimated 0.4 per cent of all hospital deliveries in those Trusts/Local Health Boards participating in the NPID audit for which provisional Hospital Episode Statistics (HES) data and Patient Episode Database for Wales (PEDW) data covering the audit period was available at the time this report was preparediii.

iii

The denominator for this percentage is based on all delivery episodes recorded in the final 2012-13 HES figures and provisional Month 13 2013-14 HES figures for those Trusts where at least one hospital participated in the NPID audit, and all delivery episodes recorded in PEDW for those Local Health Boards where at least one hospital participated. As organisations began participating in the NPID audit throughout the calendar year, the count of delivery episodes from HES/PEDW for each Trust/Local Health Board is limited to deliveries in the months beginning with the first pregnancy completion date recorded in the NPID audit by a hospital within that Trust/Local Health Board. Hospital Episode Statistics are held by the Health and Social Care Information Centre, and the Patient Episode Database for Wales is held by the NHS Wales Informatics Service.


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Table 3 shows the regional distribution of the pregnancies included in the audit. Table 3 Regional distributiona of pregnancies in the audit, 2013 Region

Number of submitting organisations

All pregnancies

Pregnancies in women with Type 1 diabetes


Pregnancies in other womenb with diabetes

Number

Number

Percentage

Number

Percentage

Number

Percentage

124

1,681

812

48.3

670

39.9

199

11.8

8

154

74

48.1

63

40.9

17

11.0

East of England

16

185

105

56.8

62

33.5

18

9.7

London

11

165

48

29.1

80

48.5

37

22.4

North East

10

159

87

54.7

69

43.4

3

1.9

North Westc

27

338

161

47.6

121

35.8

56

16.6

England East Midlands

South East

16

203

117

57.6

71

35.0

15

7.4

South West

12

179

93

52.0

60

33.5

26

14.5

West Midlands

13

151

55

36.4

75

49.7

21

13.9

Yorkshire and the Humber

11

147

72

49.0

69

46.9

6

4.1

4

23

11

47.8

10

43.5

2

8.7

Wales a b c

Based on the location of the organisation recording the pregnancy care data (which may differ from the delivery location). Women recorded as having maturity onset diabetes of the young (MODY), ‘Other’ diabetes types or whose diabetes type was not recorded. Data for the participating hospital in the Isle of Man have been included in the North West Region and the England total.


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Characteristics of women included in the audit This report covers women with diabetes who had pregnancies ending between 1st January 2013 and 31st December 2013. Participating organisations were encouraged to invite all women attending their services from the time they commenced participation to be included in the audit. Tables 4, 5 and 6 and Appendix 1 provide a description of the 1,704 pregnancies in the 1,697 women included in the audit. (There were a small number of women (seven) with more than one completed pregnancy in 2013; for consistency throughout the report the count of pregnancies includes the two pregnancies for each of these women.)

Type of diabetes The woman’s diabetes type was recorded for 1,514 of the 1,704 pregnancies included in the audit. (See the methodology section for further details.) 823 pregnancies (54.4 per cent) were in women with Type 1 diabetes and 680 (44.9 per cent) were in women with Type 2 diabetes. Table 4 provides a breakdown of the pre-pregnancy diabetes treatment regimen for the women with Type 2 diabetes in the audit. Of the 661 pregnancies in women with Type 2 diabetes where their diabetes treatment regimen was known, 27.4 per cent had been on insulin prior to their last menstrual period and 59.5 per cent were not on insulin but were taking an oral hypoglycaemic drug.

Table 4 Diabetes treatment regimen for women with type 2 diabetes in the audit, 2013 Number (N=661)

Percentage

On insulin only

Diabetes treatment regimen

90

13.6

On insulin and oral hypoglycaemic medicationa

91

13.8

393

59.5

87

13.2

On oral hypoglycaemic medication Not on insulin or oral hypoglycaemic medication a

Oral hypoglycaemic medication for this table includes metformin, sulphonylurea or glitinide, gliptin, GLP-1 analogue and pioglitazone.

Age and body mass index (BMI) of women The average age of women at completion of their pregnancy was 31.4 years; women with Type 2 diabetes were older at the end of their pregnancy, and had a shorter duration of diabetes compared with those with Type 1 diabetes (Table 5).

These figures are in line with the CEMACH5 study conducted in 2002-03, which reported that the average age (median) at delivery was 31.0 years, 33.5 years for women with Type 2 diabetes and 30.0 years for women with Type 1 diabetes.

Table 5 Characteristics of pregnancies in the audit, 2013

Average (mean) maternal age in years at completion of pregnancy N Average (mean) age in years at diagnosis N Average (mean) duration of diabetes (years) N Average (mean) Body Mass Index (BMI), kg/m2 N a

All pregnancies



31.4

29.5

33.6

1,703

822

680

21.6

15.5

29.1

1,413

766

628

9.5

13.9

4.3

1,413

766

628

29.9

26.9

33.1

1,690

815

674

All women aged 16-44 in the NDAa

Women aged 16-44 with Type 1 diabetes in the NDAa

Women aged 16-44 with Type 2 diabetes in the NDAa

27.3

16.8

33.6

7.7

13.9

4.2

31.8

26.6

34.8

The age range 16-44 has been used for the comparison to the 2012-13 NDA data as there were very few women aged over 44 in the NPID audit.


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Figure 2 shows the age distribution of those women included in the audit by diabetes type. 78.8 per cent of women with Type 2 diabetes were aged 30 years and over, compared with 51.2 per cent of women with Type 1 diabetes. Figure 2 Age group distribution of women in the audit, 2013 Percentage Pregnancies in women with Type 1 diabetes Pregnancies in women with Type 2 diabetes

40 34.4

35

31.5

31.3

30

28.0

25 20

17.3

12.2

10 5 0

16.4

15.9

15 5.0

3.5

3.3

0.3 15 to19

0.2 20 to 24

25 to 29

30 to 34

35 to 39

40 to 44

0.7

45 to 49

Maternal age at completion of pregnancy (years)

Ethnicity and deprivation The distribution of the residences of women included in the audit within these quintiles is shown in Table 6. Women resident in Wales or the Isle of Man were excluded from this analysis.

Table 6 shows the ethnicity of the women in the audit. There was a higher percentage of women with a minority ethnic origin of Black or Asian among women with Type 2 diabetes compared with those with Type 1 diabetes (37.1 per cent and 4.6 per cent respectively).

The percentage of women with Type 2 diabetes resident in the most deprived areas was higher than for those with Type 1 diabetes (41.8 per cent compared with 22.2 per cent).

Index of Multiple Deprivation (IMD) scores mapped from postcodes are ranked and split into five equal groups to give quintiles of deprivation for the population in England. 7

Table 6 Ethnicity and deprivation of women in the audit, 2013 Ethnicity

Pregnancies in women with Type 1 diabetes (N=823)

All pregnancies (N=1,540)a


Number

Percentage

Number

Percentage

Number

Percentage

White

985

64.0

641

77.9

321

47.2

Mixed

15

1.0

5

0.6

9

1.3

Asian

207

13.4

18

2.2

186

27.4

Black

88

5.7

20

2.4

66

9.7

Other

30

1.9

8

1.0

19

2.8

215

14.0

131

15.9

79

11.6

Not stated / not known Deprivationb

All pregnancies (N=1,510)a



Number

Percentage

Number

Percentage

Number

Percentage

1st quintile (least deprived)

189

12.5

128

15.9

56

8.4

2nd quintile

222

14.7

151

18.7

66

9.9

3rd quintile

290

19.2

172

21.3

110

16.5

4th quintile

340

22.5

176

21.8

156

23.4

5th quintile (most deprived)

469

31.1

179

22.2

279

41.8

or data collected via the NPID online submission tool, ethnicity and deprivation quintile is only available where the woman’s details are included in the 2011-12 F or 2012-13 NDA. b The index of multiple deprivation (IMD) quintiles are based on the postcode of the woman’s place of residence and are only available for England. a


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Were women adequately prepared for pregnancy? The NICE guideline for diabetes in pregnancy (CG63)3 states that women with diabetes should be informed of the importance of good glycaemic control to reduce the risk of miscarriage, congenital abnormality, stillbirth and neonatal death, as well as a recommendation to take high dose folic acid (5mg daily).

Less than half of the women in the audit (40.1 per cent) had been taking any folic acid prior to their last menstrual period (Table 7). The percentage taking folic acid was higher in women with Type 1 diabetes than women with Type 2 diabetes (47.3 per cent compared with 34.4 per cent).

This section of the report provides evidence of achievement against the NICE guideline looking in particular at folic acid supplement and HbA1c control.

Although there is no change in the overall percentage of women using folic acid compared with the CEMACH5 study (39.2 per cent), the figures by diabetes type indicate that uptake has increased for women with each diabetes type (in the CEMACH study 42.9 per cent of women with Type 1 diabetes and 29.4 per cent of women with Type 2 diabetes were documented as taking folic acid).

Folic acid supplement Women with diabetes have an increased risk of having a pregnancy affected by a neural tube defect and NICE guidance is that they should take a higher dose of 5 milligrams (5mg) of folic acid while planning pregnancy and then up to 12 weeks gestation to reduce the risk of having a baby with a neural tube defect. Table 7 Use of folic acid supplement prior to pregnancy in the audit, 2013 All pregnancies (N=1,704)



Number

Percentage

Number

Percentage

Number

Dose 400mcg

121

7.1

38

4.6

66

9.7

Dose 5mg

562

33.0

351

42.6

168

24.7

All doses

683

40.1

389

47.3

234

34.4

Not taken

756

44.4

316

38.4

333

49.0

Not knowna

265

15.6

118

14.3

113

16.6

a

Percentage

‘Not known’ in this table includes women who were recorded to be taking folic acid but with an unknown dose.

HbA1c control Women with diabetes who are planning to become pregnant should aim to establish good glycaemic control before conception and continue this throughout pregnancy (NICE CG633). This reduces the risk of miscarriage, congenital anomalies, stillbirth and neonatal death. 1,207 of the 1,704 pregnancies included in the audit had an HbA1c measurement recorded in the first trimester (the first 13 weeks of pregnancy).

Table 8 shows these first trimester HbA1c measurements. A NICE recommended first trimester HbA1c level of less than 43 mmol⁄mol (6.1%) was recorded in 131 pregnancies (10.9 per cent of all pregnancies). Only 5.1 per cent of pregnancies in women with Type 1 diabetes had an HbA1c measurement below the NICE recommended target, compared with 18.5 per cent of pregnancies in women with Type 2 diabetes. 10.8 per cent of women with Type 1 diabetes and 8.6 per cent of women with Type 2 diabetes had a first trimester HbA1c measurement of 86 mmol/mol (10.0%) or more, the level at which the NICE guideline says women with diabetes should be strongly advised to avoid pregnancy.

Table 8 First trimester HbA1c measurement in the audit, 2013 All pregnancies (N=1,207) Number


Percentage

Number


Percentage

Percentage

61.8

Result 86 mmol/mol (10%)

123

10.2

68

10.8

39

8.6


64.5

Number

Mean HbA1c value (mmol/mol)

58.2 18.5

16

In this report we define ‘adequately prepared for pregnancy’ as taking folic acid (400mcg or 5mg) prior to pregnancy, and having a first trimester HbA1c measurement of less than 53 mmol/mol (7.0%). Of the 683 women taking 400mcg or 5mg of folic acid, 221 (32.4 per cent) achieved a first trimester HbA1c level of less than 53 mmol/mol (7.0%). Of the 1,067 women who had a first trimester HbA1c value and details of whether they were taking folic acid prior to pregnancy recorded in the audit, 221 (20.7 per cent) were adequately prepared for pregnancy. Among women with Type 1 diabetes, 18.4 per cent were adequately prepared, while 25.1 per cent of women with Type 2 diabetes were adequately prepared.

Diabetes treatment regimen prior to pregnancy Table 9 shows the number of women on selected diabetic treatment regimens prior to their last menstrual period. The only medications known to be safe in pregnancy are insulin and metformin. Therefore, almost one in ten women with Type 2 diabetes became pregnant while taking a potentially hazardous glucose lowering medication. Table 9 Diabetes treatment regimen prior to the last menstrual period in the audit, 2013a All pregnancies (N=1,704)



Number

Percentage

Number

Percentage

Number

Percentage

On insulin only

915

53.7

756

91.9

90

13.2

On insulin and metformin only

117

6.9

28

3.4

82

12.1

On metformin only

407

23.9

6

0.7

330

48.5

73

4.3

3

0.4

64

9.4

On other diabetes medicationsb a b

There are other diabetes treatment combinations not shown in this table. ‘Other diabetes medications’ in this table are sulphonylurea or glitinide, gliptin, GLP-1 analogue and pioglitazone, irrespective of whether the woman was also taking metformin and/or insulin.

There were 915 women on insulin alone as their diabetes treatment regimen at the start of their pregnancy. Table 10 shows the number of women on each insulin treatment where this is known. Table 10 Insulin treatment of women on insulin only in the audit, 2013a All pregnancies (N=843)



Number

Percentage

Number

Percentage

Number

Percentage

Basal bolus insulin regimen

572

67.9

466

67.7

49

57.0

Mixed insulin or basal insulin only

127

15.1

86

12.5

34

39.5

Insulin pump therapy

140

16.6

132

19.2

3

3.5

4

0.5

4

0.6

0

0.0

Multiple insulin treatments a

ata on the type of insulin treatment are collected differently in the NPID online submission tool and the NorDIP survey. This table includes information collected D via the NPID online submission tool only.


17

Women with diabetes have increased risks of kidney and cardiovascular disease so may be prescribed statins, angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs), drugs that are known to have potential to cause fetal harm. NICE recommends3 that these drugs should be discontinued before pregnancy or as soon as pregnancy is confirmed. The following tables (Table 11 and 12) detail the recorded use of these drugs at conception among the women included in the audit. Table 11 Use of statins prior to last menstrual period in the audit, 2013 All pregnancies (N=1,704) On statins Not on statins Not known



Number

Percentage

Number

Percentage

Number

80

4.7

21

2.6

51

Percentage 7.5

1,574

92.4

776

94.3

608

89.4

50

2.9

26

3.2

21

3.1

Table 12 Use of ACE inhibitor/ARB prior to last menstrual period in the audit, 2013 All pregnancies (N=1,704) On ACE inhibitor/ARB Not on ACE inhibitor/ARB Not known



Number

Percentage

Number

Percentage

Number

39

2.3

11

1.3

23

Percentage 3.4

1,611

94.5

787

95.6

630

92.6

54

3.2

25

3.0

27

4.0

6.0 per cent of women were taking either statins or an ACE inhibitor/ARB or both medications when they became pregnant (3.5 per cent of women with Type 1 diabetes and 9.4 per cent of women with Type 2 diabetes).


18

Care in pregnancy and HbA1c control Women with diabetes who become pregnant are at higher risk of having an adverse outcome that includes miscarriage, congenital abnormality, stillbirth and neonatal death. It is therefore important that they have contact with a joint diabetes and antenatal clinic, and that their glycaemic control is assessed regularly.

Gestation at first contact with specialist antenatal diabetes team First contact with a specialist antenatal diabetes team should take place as early as possible in pregnancy to ensure that any pregnancy risks not addressed prepregnancy are corrected promptly. Figure 3 shows that over half (51.2 per cent) of women with Type 1 diabetes had their first contact with the specialist team prior to 8 weeks gestation, but only just over one third (36.6 per cent) of women with Type 2 diabetes had their first contact with the team within this time. There were a small number of pregnancies where the initial contact with the team is after the first trimester. The average gestation at first contact was 8.2 weeks for women with Type 1 diabetes and 9.7 weeks for women with Type 2 diabetes. Figure 3 Gestation (completed weeks) at first contacta with specialist antenatal diabetes team, 2013

0 to 1

4 to 5

0.6

0.1

0.5

0.5

0.3

0.1

0.5

0.4

0.5

0.3

1.1

2.8

0.8

1.9

6.0

7.3 6 to 7

1.6

22.9

2.4

1.1

1.1

2 to 3

0.3

0

0.8

5

0.6

10

13.2

15

13.6

20

22.3

30.1 25.0

25

12.4


30 19.3


35

9.8

Percentage

8 to 9 10 to 11 12 to 13 14 to 15 16 to 17 18 to 19 20 to 21 22 to 23 24 to 25 26 to 27 28 to 29 30 and over Completed weeks gestation at first contact

a

Very early appointments are likely to be preconception care appointments already in place before the woman knew she was pregnant.

HbA1c control Table 13 shows HbA1c control during pregnancy by completed weeks of gestation. The first and last HbA1c measurements in pregnancy were recorded as part of the audit, these have been grouped by gestation, and where the two measurements were in the same gestation period the last measurement has been used (Tables 8, 13 and 18).


19

Table 13 HbA1c control during pregnancy by completed weeks of gestation, 2013 Completed weeks of gestation 86 mmol/mol (10.0%)

78

12.4

11

12.6

2

3.8

13

2.2

68

10.8

3

3.4

0

0.0

14

2.4

Pregnancies in women with Type 2 diabetes Mean HbA1c (mmol/mol)

58.2

49.2

48.0

44.5

Number of pregnancies where HbA1c recorded

453

84

64

443

HbA1c measurement

Number

Percentage

Number

Percentage

Number

Percentage

Number

84

18.5

29

34.5

26

40.6

224

50.6

43-52 mmol/mol (6.1% - 6.9%)

124

27.4

29

34.5

20

31.3

133

30.0 15.1

< 43 mmol/mol (6.1%)

Percentage

53-63 mmol/mol (7.0% - 7.9%)

105

23.2

14

16.7

12

18.8

67

64-74 mmol/mol (8.0% - 8.9%)

63

13.9

6

7.1

3

4.7

14

3.2

75-85 mmol/mol (9.0% - 9.9%) >86 mmol/mol (10.0%)

38

8.4

5

6.0

1

1.6

5

1.1

39

8.6

1

1.2

2

3.1

0

0.0

The table shows that the average HbA1c value falls as the pregnancies progress in both women with Type 1 and Type 2 diabetes; from 64.5 mmol/mol in the first trimester to 51.9 mmol/mol in the gestation period beyond 24 weeks for women with Type 1 diabetes and from 58.2 mmol/mol to 44.5 mmol/mol for women with Type 2 diabetes. HbA1c falls physiologically in pregnancy because of changes in iron transport and red cell turnover8, so it is not possible to say whether this fall represents an improvement in glycaemic control. (The NICE guideline3 states that HbA1c should not be used routinely for assessing glycaemic control in the second and third trimesters of pregnancy.)


20

Were adverse fetal/infant outcomes minimised? This section looks at the reported outcome of the pregnancies and whether any adverse outcomes occurred.

Pregnancy outcomes There were 1,731 pregnancy outcomes recorded in the audit in 2013, of which 1,677 were singleton pregnancies. Table 14 shows that there were 771 live births from 782 registered births for women with Type 1 diabetes (98.6 per cent) and 644 (98.6 per cent) registered births for women with Type 2 diabetes were live births. In England and Wales, 99.5 per cent of all registered births in 2013 were live birthsiv. Table 14 Pregnancy outcomes in the audit, 2013 Outcome Total

Live birth

Stillbirth

Miscarriage

Termination of pregnancy

All pregnancies All pregnancies

1,731

1,588

26

97

20


832

771

11

40

10


698

644

9

38

7

Pregnancies continuing at 24 weeks gestationa 1,606

1,576

26

4b

0


All pregnancies

778

767

11

0

0


650

638

9

3

0

a b

Excludes pregnancies with unknown gestation length at delivery. These pregnancy outcomes may not be correctly classified as miscarriages as the gestation length was recorded as 24 completed weeks or more.

The NICE guideline3 states that pregnant women with diabetes who have a normally grown fetus should be offered elective birth through induction of labour, or by elective caesarean section if indicated, after 38 completed weeks. Figure 4 shows how the gestation length was distributed for pregnancies ongoing at 24 completed weeks in Type 1 and Type 2 women in the audit. Figure 4 Gestation length of pregnancies by diabetes type for singleton live births and stillbirths in the audit, 2013 Percentage

50 44.0

45 Pregnancies in women with Type 1 diabetes

40


30

33.7

35 25.0

23.6

25

21.9

20 15

12.6

10 5 0

12.3

7.0 0.1

1.3

24 to 27

1.8

1.3

28 to 30

3.3

1.0

31 to 32

4.7

2.3 33 to 34

0.8 35 to 36

37

38

39

3.4

40 and over

Completed weeks gestation at delivery iv

Source: Office for National Statistics, Births in England and Wales, 20139


21

spontaneous labour or elective intervention. This data is expected to be included in future reports.

The mean gestational age at delivery for singleton pregnancies ongoing at 24 weeks was 36.6 weeks for women with Type 1 diabetes and 37.2 weeks for women with Type 2 diabetes.

28.8 per cent of pregnancies recorded in the audit where the pregnancy was ongoing at 24 completed weeks were delivered preterm. In the 2002–03 CEMACH5 study, 35.8 per cent of pregnancies ongoing at 24 weeks had a preterm delivery. The audit shows a higher proportion (36.3 per cent) of pregnancies in women with Type 1 diabetes were delivered preterm compared with the proportion of preterm deliveries (19.7 per cent) in women with Type 2 diabetes.

A greater proportion (59.6 per cent) of women with Type 2 diabetes had pregnancies continuing at 38 weeks gestation than women with Type 1 diabetes (39.2 per cent). Babies delivered before 37 completed weeks of gestation are classed as preterm. For this report, we do not have data on whether the preterm deliveries result from

Table 15 Gestation at delivery by outcome, for singleton live and stillbirths after 24 completed weeks in the audit, 2013a All births (N=1,561) Completed weeks gestation

Births to women with Type 1 diabetes (N=764)

Alive at 28 days

Stillbirth

Neonatal death

24-27

4

3

28-30

21

3

31-32

38

33-34

Births to women with Type 2 diabetes (N=618)

Alive at 28 days

Stillbirth

Neonatal death

Alive at 28 days

Stillbirth

Neonatal death

2

0

1

0

4

1

2

0

12

1

0

5

1

0

1

0

25

0

0

6

0

0

69

0

1

46

0

1

14

0

0

35-36

262

7

0

166

5

0

69

2

0

37-38

884

8

8

408

3

5

382

2

3

39-40

147

1

3

38

0

0

88

1

3

41-42

4

0

0

2

0

0

1

0

0

10

1

0

4

0

0

4

1

0

1,439

24

14

701

10

6

573

8

8

Unknown Total a

84 live births for which the ‘Alive at 28 days’ status was recorded as ‘Not known’ are excluded from this table.

Table 16 Stillbirth and neonatal mortality in the audit, 2013 Number

Rate

95% confidence interval lower limit

95% confidence interval upper limit

Stillbirth (rate per 1,000 live and stillbirths)

26

16.1

10.5

23.6

Neonatal death (rate per 1,000 live births)

17

10.7

6.2

17.1

In 2012 in England and Wales, the stillbirth rate for all births was 4.9 per 1,000 live and stillbirthsv, and the neonatal death rate was 2.8 per 1,000 live birthsvi.

the age distribution of the women in the NPID audit compared with all women giving birth, and the geographical coverage of the NPID audit in its first year is less complete than the CEMACH study.

Comparisons between the NPID rates (Table 16) and other rates should be made cautiously – for example, the national rates have not been adjusted to take into account Table 17 Congenital anomalies by diabetes type, 2013a All pregnancy outcomes (N=1,648) Congenital anomaly No congenital anomaly Not known

Outcomes for women with Type 1 diabetes (N=795)

78

36

32

1,491

722

602

79

37

34

a

Includes live births and terminations at any stage of the pregnancy, stillbirths, and miscarriages after 20 weeks.

v

Source: Office for National Statistics, Births in England and Wales, 201210 Source: Office for National Statistics, Childhood, Infant and Perinatal Mortality In England and Wales,201211

vi


Outcomes for women with Type 2 diabetes (N=668)

22

The rate of congenital anomalies in the pregnancies recorded in the audit was 48.3 per 1,000 live and stillbirths (with a 95 per cent confidence interval of (38.2, 60.3)). The British Isles Network of Congenital Anomaly Registers (BINOCAR)15 reported an anomaly rate of 21.9 per 1,000 live and still births for 2011. When comparing these rates, it should be noted that differences in the recording methods of the audit and the Registers may contribute to the difference in rates.

For example, the counts for the NPID audit include all pregnancies where any congenital anomaly was reported, irrespective of type, whereas the BINOCAR rate specifically excludes certain anomalies (see Appendix B of the BINOCAR report). Table 18 illustrates the relationship between HbA1c measurement by gestation period linked to outcomes of the pregnancy.

Table 18 HbA1c control at various stages in pregnancy and pregnancy outcomes in the audit, 2013 Completed weeks of gestation