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Aims/hypothesis Women with diabetes remain at increased risk of adverse pregnancy outcomes associated with poor pregnancy preparation. However, women with type 2 diabetes are less aware of and less likely to access pre-pregnancy care (PPC) compared with women with type 1 diabetes. We developed and evaluated a community-based PPC programme with the aim of improving pregnancy preparation in all women with pregestational diabetes. Methods This was a prospective cohort study comparing pregnancy preparation measures before and during/after the PPC intervention in women with pre-existing diabetes from 1 June 2013 to 28 February 2017. The setting was 422 primary care practices and ten National Health Service specialist antenatal diabetes clinics. A multifaceted approach was taken to engage women with diabetes and community healthcare teams. This included identifying and sending PPC information leaflets to all eligible women, electronic preconception care templates, online education modules and resources, and regional meetings and educational events. Key outcomes were preconception folic acid supplementation, maternal HbA level, use of potentially harmful medications at conception and gestational age at first presentation, before and 1c during/after the PPC programme. Results A total of 306 (73%) primary care practices actively participated in the PPC programme. Primary care databases were used to identify 5075 women with diabetes aged 18–45 years. PPC leaflets were provided to 4558 (89.8%) eligible women. There were 842 consecutive pregnancies in women with diabetes: 502 before and 340 during/after the PPC intervention. During/after the PPC intervention, pregnant women with type 2 diabetes were more likely to achieve target HbA levels ≤48 mmol/mol (6.5%) (44.4% of women before vs 58.5% of women 1c during/after PPC intervention; p = 0.016) and to take 5 mg folic acid daily (23.5% and 41.8%; p = 0.001). There was Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00125-018-4613-3) contains peer-reviewed but unedited supplementary material, which is available to authorised users. * Helen R. Murphy Department of Diabetes and Endocrinology, Bedford Hospital email@example.com NHS Trust, Bedford, UK The Ipswich Diabetes Centre, Ipswich Hospitals NHS Trust, Department of Medicine, Division of Endocrinology and Ipswich, UK Metabolism, University of Calgary, Calgary, Canada East and North Herts Institute of Diabetes and Endocrinology Wolfson Diabetes and Endocrine Clinic, Cambridge University (ENHIDE), East and North Hertfordshire NHS Trust, Stevenage, UK Hospitals NHS Foundation Trust, Cambridge, UK Department of Public Health and Primary Care, School of Clinical Wellcome Trust–Medical Research Council Institute of Metabolic Medicine, University of Cambridge, Cambridge, UK Science, University of Cambridge, Cambridge, UK Department of Diabetes and Endocrinology, Norfolk and Norwich North East Essex Diabetes Service (NEEDS), Colchester Hospital University Hospital, Norwich, UK University NHS Foundation Trust, Colchester, UK Norwich Medical School, Floor 2, Bob Champion Research and Department of Diabetes and Endocrinology, West Suffolk Hospital Education Building, University of East Anglia, Norwich NR4 7UQ, NHS Trust, Bury St Edmunds, UK UK Diabetologia (2018) 61:1528–1537 1529 an almost threefold improvement in ‘optimal’ pregnancy preparation in women with type 2 diabetes (5.8% and 15.1%; p = 0.021). Women with type 1 diabetes presented for earlier antenatal care during/after PPC (54.0% vs 67.3% before 8 weeks’ gestation; p = 0.003) with no other changes. Conclusions/interpretation A pragmatic community-based PPC programme was associated with clinically relevant improve- ments in pregnancy preparation in women with type 2 diabetes. To our knowledge, this is the first community-based PPC intervention to improve pregnancy preparation for women with type 2 diabetes. Data availability Further details of the data collection methodology, individual clinic data and the full audit reports for healthcare professionals and service users are available from https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/our- clinical-audits-and-registries/national-pregnancy-in-diabetes-audit. . . . . . . . . Keywords Antenatal Community-based Diabetes Folicacid Glucose Glycaemiccontrol Pregnancy Pre-pregnancycare Primary care Abbreviations Introduction CCG Clinical commissioning group EAHSN Eastern Academic Health Science Network Women with pregestational diabetes remain at increased risk of EASIPOD East Anglia Study Group for Improving adverse pregnancy outcomes associated with suboptimal preg- Pregnancy Outcomes in Women with Diabetes nancy preparation [1, 2]. A large national cohort in the UK GROW Gestation Related Optimal Weight demonstrated that only 14% of women with type 1 diabetes NICE National Institute for Health and Care Excellence and 37% of women with type 2 diabetes achieve the National NPID National Pregnancy in Diabetes Institute for Health and Care Excellence (NICE) guideline PPC Pre-pregnancy care HbA target of 48 mmol/mol (<6.5%) [3, 4]. Furthermore, 1c only 46% and 23% of women with type 1 and type 2 diabetes 1530 Diabetologia (2018) 61:1528–1537 respectively, were taking 5 mg of folic acid daily prior to con- Methods ception . This leaves much room for improvement. Pre-pregnancy care (PPC) has been shown to improve A multifaceted approach was taken to engage women with pregnancy preparation measures such as preconception folic diabetes (type 1, type 2 and other, including MODY) as well acid supplementation, periconception glycaemic control, as their primary healthcare providers, including primary care avoiding potentially harmful medications and presenting for practitioners and community healthcare teams in the Eastern early antenatal care [5–7]. We previously demonstrated that Academic Health Science Network (EAHSN) (see electronic although women with type 2 diabetes have additional obstetric supplementary material [ESM] for details of participating clin- risk factors (higher age, parity, BMI) compared with women ical commissioning groups [CCGs]). This included identifying who have type 1 diabetes, PPC is as effective in reducing the and sending theoretically guided (balancing the risk of unat- risk of serious adverse pregnancy outcomes in type 2 as in tended pregnancy and benefits of pregnancy preparation) pa- type 1 diabetes [5, 8]. Despite its well-established benefits and tient information leaflets to all eligible women (ESM Fig. 1), widespread recommendation, PPC attendance continues to be providing preconception care templates for use during face-to- low [4–6, 9, 10]. Even in regions with specialist programmes, face primary care visits (ESM Fig. 2), providing online PPC only a third of women with type 2 diabetes attend PPC [5, 6]. education modules and resources, as well as participating in a Conversely, the use of contraception also continues to be low, series of regional and local educational events for patients and with less than half of women with type 1 and type 2 diabetes healthcare professionals. The NPID patient information leaflet on potentially harmful prescribed medications using safe, ef- and consent form met the Health Research Authority require- fective methods of contraception . ments for clinical audit, and research ethics approval was not Most women with type 2 diabetes have routine care in required. primary care settings, where awareness of the specific issues of diabetes pregnancy preparation is limited [8, 12]. This leads Pre-existing regional programme This community-based pro- to low levels of awareness regarding the importance of safe, gramme was established in addition to the existing East effective contraception to avoid an unintended pregnancy and Anglia Study Group for Improving Pregnancy Outcomes in of PPC in women who are thinking about trying for a baby. Women with Diabetes (EASIPOD) programme [5, 8, 14]. Women with type 2 diabetes are more likely to live in areas of EASIPOD was established in 2006 to improve specialist socioeconomic deprivation and belong to ethnic minority PPC clinic attendance. It involved the mailing of leaflets to groups so may have additional financial, cultural and ethnic women with diabetes by the specialist antenatal diabetes barriers to accessing healthcare [8, 12]. teams, and dissemination of information to various healthcare Qualitative interviews suggested that women with type 2 professionals. It was not community based and did not sys- diabetes had common misconceptions about their reproduc- tematically include primary care practitioners. tive potential [13, 14], thinking it was ‘harder to conceive’ with poorly controlled diabetes and high BMI [13, 14]. PPC leaflet Primary care centre databases (SystmOne and Some overweight and obese women were advised that they EMIS) were searched using specific Read codes (https:// had ‘toomanyriskfactors’ for hormonal contraception. digital.nhs.uk/article/1104/Read-Codes) to identify women Others reported concerns regarding the negative views of with diabetes aged 16–45 years. Women who were currently women with type 2 diabetes and pre-pregnancy discussions pregnant, recently widowed, or who had had a previous [13, 15]. Information about diabetes pregnancy was seen as hysterectomy, serious medical and/or psychological problems too ‘risk-focused’ and ‘alarming’, concentrating on ‘all the were excluded. The theoretically guided EASIPOD PPC infor- bad things that could happen’ . Women stated a preference mation leaflet was revised to reflect the feedback from women for clear practical advice about sex and diabetes with less who previously did not attend for PPC . It was deliberately emphasis on ‘preconception and having a baby’ . as inclusive as possible, focusing more on sex and contracep- There is an unmet need to improve women’s and healthcare tion with less emphasis on ‘trying for a baby’, which previous professionals’ awareness about diabetes pregnancy risks and research suggested was a potential barrier for hard-to-reach how they can be minimised by optimal pregnancy preparation women (ESM Fig. 1). Printed and electronic copies of the . To address this, we developed and implemented an inte- revised PPC leaflet were distributed to 422 primary care centres grated community-based PPC programme for women with and ten specialist diabetes maternity clinics. A nominal pay- pregestational diabetes (type 1, type 2 and other), focusing on ment of £20 was offered to participating primary care centres to engaging primary care diabetes teams. This study assesses its cover their administrative costs of identifying eligible women effectiveness on pregnancy preparation measures and pregnan- and mailing the leaflet (database search, stationery, postage). cy outcomes in women with pre-existing diabetes. We hypothesised that a community-based PPC programme would Electronic preconception care templates Preconception care templates were embedded into electronic healthcare records, improve pregnancy preparation in women with type 2 diabetes. Diabetologia (2018) 61:1528–1537 1531 with pop-up alerts as an aide-memoire, to promote use during Data collection Health care professionals at each specialist clinical encounters (ESM Fig. 2). Women not using safe, ef- National Health Service maternity unit completed standardised fective contraception were advised to consider a long-acting National Pregnancy in Diabetes (NPID) web-based data entry reversible contraception method. Women thinking about try- forms (http://content.digital.nhs.uk/media/15927/NPID-Data- ing for a baby were advised to take 5 mg folic acid daily, to Collection-Form-v6/pdf/NPID_Data_Collection_Form_v6. aim for HbA ≤48 mmol/mol (6.5%), have a review of their pdf) for every pregnant woman with pregestational diabetes 1c current medications and their most recent renal, retinal and who delivered between 1 June 2013 and 28 February 2017. thyroid screening results. Specific recommendations for refer- All women provided written informed consent for NPID data ral to a specialist diabetes pre-pregnancy service were made collection. The project midwife ensured timely data collection, for women with HbA >53 mmol/mol (7%), BMI>30 kg/m validation of the data and entry into the study database. When 1c and women with additional medical or obstetric risk factors necessary, the project coordinator contacted individual sites to (ESM Fig. 2). ensure completeness and accuracy of the data. The pregnancy preparation and pregnancy outcome data were reviewed on a Online resources An online diabetes education programme centre-by-centre basis at the quarterly regional meetings. (Cambridge Diabetes Education programme, www.cdep.org. uk; accessed 1 October 2015) was offered, free of charge, to Definitions and outcomes We defined pre-existing diabetes as all participating primary and specialist care practices. In diabetes that had been diagnosed before pregnancy and ex- addition, practices were invited to participate in a pilot cluded women who presented with diabetes during pregnancy. evaluation of the Diabetes UK preconception information The mother’s diabetes type was added to the NPID data col- prescription www.diabetes.org.uk/professionals/resources/ lection as a mandatory data item from 1 January 2015 and was resources-to-improve-your-clinical-practice/information- obtained by linking to the most recent relevant National prescriptions-qa/information-prescription–diabetes- Diabetes Audit record. Prior to January 2015, the type of contraception-and-pregnancy (accessed 1 May 2016). diabetes was determined by the treating clinicians and manu- ally entered into the NPID database. Where the diabetes type Regional meetings A project midwife was supported by local entered on the NPID system was not known, National project coordinators (each working 1–2 days/week) in seven Diabetes Audit linkage was also used in order to establish a CCG areas. The project coordinators directly engaged with known diabetes type for as many women as possible. All types local CCG leads, family physicians, primary care nurses, spe- of pre-existing diabetes were included. The HbA was mea- 1c cialist diabetes teams, sexual health clinics, community groups sured locally, with the first and last recorded values during and women with diabetes. Regional meetings were held every pregnancy collected as per the NPID audit . Target HbA 1c 4 months to review pregnancy preparation and pregnancy out- was defined as ≤48 mmol/mol (6.5%) in accordance with come data both during the baseline data collection before PPC NICE guidelines . Optimal pregnancy preparation was de- programme implementation (June 2013 to September 2015; fined as having all of the following: on 5 mg folic acid sup- 28 months) and during/after implementation (October 2015 to plementation, not taking any potentially harmful medications February 2017; 17 months). The project midwife, local coordi- prior to last menstrual period, first HbA following confirma- 1c nators and members of the National Health Service specialist tion of a positive pregnancy test ≤48 mmol/mol (6.5%) and diabetes pregnancy teams attended these meetings, which presentation for antenatal diabetes care before 8 weeks’ ges- allowed teams to share experiences about what PPC engage- tation. Medications considered potentially harmful included ment activities worked and/or did not work. secretagogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, thiazolidinediones, Project cost The total cost for this large regional programme angiotensin converting enzyme inhibitors, angiotensin recep- included non-recurring programme management and tor blockers and statins. organisational costs, as well as staff who also delivered several We used standard NPID definitions for congenital anoma- other diabetes improvement programmes. We estimated that ly, stillbirth and neonatal death and collected data on congen- to deliver this model in a general UK population of 750,000 ital anomalies for live births, stillbirths and pregnancy loss individuals including 58,000 with diabetes, the service would after 20 weeks’ gestation. The reported diagnoses for major require recurring salary costs for a 0.25 whole-time equivalent congenital anomaly, as defined by the European Surveillance project manager (£9,589) and three 0.25 whole-time equiva- of Congenital Anomalies (EUROCAT), were obtained from lent diabetes educators / midwives (£28,767), as well as non- the hospital ICD-10 codes (www.who.int/classifications/icd/ recurring initial modest costs for materials development en/). All congenital anomaly coding was reviewed in (£5,000) and primary care database searches, stationery and duplicate. Minor congenital anomalies were not included. postage (£20 × 306 = £6,120). This brings the total estimated Infant birthweight was adjusted for maternal height, intervention cost to £49,476 per annum. weight, infant sex and gestational age using customised 1532 Diabetologia (2018) 61:1528–1537 centile calculators (Gestation Related Optimal Weight Specialist antenatal diabetes care participation Of the 842 [GROW] centile tool v126.96.36.199 [UK] 2015 Gestation women who presented with pregnancies complicated by dia- Network) (www.gestation.net/birthweight_centiles/centile_ betes, 513 (60.9%) had type 1 diabetes, 318 (37.8%) had type object.htm, accessed 8 November 2017). 2 diabetes and 11 (1.3%) had other types of diabetes in preg- nancy. Specialist clinics varied by number of pregnancies in Statistical analysis Differences before and during/after the im- women with pre-existing diabetes, which ranged from 32–173 plementation of the programme were analysed using t tests for women. A total of 502 women who attended before and 340 continuous variables and Fisher’s exact test for categorical women who attended during/after the PPC programme were variables after ensuring test assumptions were met. A two- included. sided p value of <0.05 was considered statistically significant. Analyses were performed using Stata, version 14.1. Maternal characteristics The proportion of women with type 1 and type 2 diabetes remained consistent over time (61.4% before vs 60.3% with type 1 diabetes during/after the pro- gramme; p = 0.77), as did maternal BMI at booking (29.3 ± 2 2 Results 7.2 kg/m vs 29.8 ± 6.9 kg/m ; p = 0.29) (ESM Table 1). Women who attended during/after the implementation of the Primary care participation Out of 422 primary care centres PPC programme were younger (31.4 ± 5.9 vs 32.5 ± 5.9 years; identified, 306 (72.5%) actively participated in the pro- p = 0.0074). Details of maternal characteristics before and gramme. Collectively, they identified 5075 women with during/after intervention are found in ESM Table 1. pregestational diabetes aged 16–45 years, excluded 514 for Less than half of women with type 1 diabetes (41.0% be- whom it was considered inappropriate, and sent the pre- fore and 36.1% during/after PPC; p =0.27) andapproximately pregnancy information leaflet to the remaining 4,558 one in ten with type 2 diabetes (12.4% before and 9.9% (89.8%) (Table 1). The primary care response rate exceeded during/after PPC; p = 0.59) had a BMI in the normal range 75% in five out of seven CCG areas. Details according to each of <24.9 kg/m . Details of maternal characteristics by type CCG area are shown in Table 1. of diabetes (type 1 or type 2) are shown in Table 2. Login codes for the online diabetes education programme For women with type 1 diabetes, 23.1% and 22.4% used (Cambridge Diabetes Education Programme) were created for insulin pump therapy before and during/after PPC respective- up to 1500 users. Of those, 311 individuals registered for the ly, and 7.5% and 10.7% were taking metformin in early preg- programme. This included individuals from primary care nancy before and during/after PPC respectively. For women practices (182), hospitals (57) and other institutions such as with type 2 diabetes, 72.0% and 69.7% respectively were care homes, pharmacies, community trusts etc. (72). A total of taking metformin in early pregnancy. 221 individuals started at least one module and 75 completed at least one module during the 17 month PPC programme Pregnancy preparation Almost two-thirds (64.2–64.6%) of implementation phase. The most popular completed modules women with type 1 diabetes were on folic acid before concep- were: What is diabetes? (n = 63), Hypoglycaemia (n = 52), tion with very few (<4%) taking any potentially harmful med- Hyperglycaemia (n = 39), Screening and early detection of ications before and during/after PPC implementation type 2 diabetes (n = 36) and Preconception care (n =32). (Table 3). In women with type 1 diabetes, only gestational Table 1 Women with diabetes identified and sent PPC leaflets by CCG areas CCG area Primary care Primary care Women with PPC leaflets practices contacted practice replies diabetes identified sent Norfolk and Waveney 110 83 (75.5%) 1438 1246 Cambridgeshire and Peterborough 107 81 (75.7%) 1289 1276 East and North Hertfordshire 59 46 (78%) 699 583 Ipswich and East Suffolk 40 35 (87.5%) 638 549 West Suffolk 25 24 (96.0%) 425 397 Bedfordshire 40 13 (32.5%) 199 176 North East Essex 41 24 (58.5%) 387 331 Total 422 306 (72.5%) 5075 4558 (89.8%) Norfolk and Waveney are comprised of the following CCGs: Norwich, North Norfolk, South Norfolk, West Norfolk, Great Yarmouth and Waveney Diabetologia (2018) 61:1528–1537 1533 Table 2 Maternal characteristics before and during/after implementation of a regional PPC programme by type of diabetes Type 1 diabetes Type 2 diabetes Characteristic Before PPC During/after PPC p value Before PPC During/after PPC p value n=308 n=205 n=186 n=132 Age in years at delivery, mean (SD) 31.2 (5.9) 30.2 (5.8) 0.058 34.7 (5.2) 33.4 (5.4) 0.026 Diabetes treatment at first visit, n (%) Insulin pump 71 (23.1) 46 (22.4) 0.92 0 (0) 0 (0) – Metformin 23 (7.5) 22 (10.7) 0.21 134 (72.0) 92 (69.7) 0.71 Weight at booking in kg, mean (SD) 71.8 (13.8) 74.2 (15.2) 0.068 91.2 (24.5) 90.8 (21.5) 0.87 BMI at booking in kg/m , mean (SD) 26.5 (4.6) 27.3 (5.3) 0.068 34.3 (8.0) 33.9 (7.2) 0.71 Normal (<24.9) 126 (41.0) 74 (36.1) 0.27 23 (12.4) 13 (9.9) 0.59 Overweight (25–29.9) 125 (40.7) 75 (36.6) 0.36 31 (16.7) 28 (21.2) 0.31 Obese (≥30) 56 (18.2) 56 (27.3) 0.017 132 (71.0) 91 (68.9) 0.71 Maternal weight at booking was available for all but one participant with type 1 diabetes before PPC age at booking (8.4 ± 3.5 vs 7.6 ± 3.7 weeks; p =0.020) and In contrast, women with type 2 diabetes were significantly booking prior to 8 weeks’ gestation (54% vs 67.3%; p = more likely to achieve a target HbA ≤48mmol/mol (6.5%) 1c 0.003) improved significantly (Table 3). There was a trend (44.4% before vs 58.5% during/after PPC implementation; towards increasing ‘optimal’ preparation for pregnancy, but p = 0.016) and to take preconception folic acid, both for ‘any this did not reach statistical significance (10.6% vs 16.3%; dose’ (36.6% before vs 48.9% during/after PPC implementa- p =0.086). tion; p = 0.041) and for the NICE recommended 5 mg dose Table 3 Measures of pregnancy preparation before and during/after implementation of a regional PPC programme by type of diabetes Type 1 diabetes Type 2 diabetes Measure Before PPC During/after PPC p value Before PPC During/after PPC p value a a a a n=308 n=205 n=186 n=132 Booking time n =304 n =205 n =185 n =132 Gestational age at booking in weeks, mean (SD) 8.4 (3.5) 7.6 (3.7) 0.020 10.5 (4.5) 9.8 (4.9) 0.25 Booking prior to 8 weeks, n (%) 164 (54.0) 138 (67.3) 0.003 62 (33.5) 53 (40.2) 0.24 HbA n =287 n =198 n =178 n =130 1c HbA at first contact in mmol/mol, mean (SD) 62.2 (18.3) 61.5 (17.3) 0.65 52.2 (14.9) 50.4 (14.8) 0.30 1c HbA at first contact in %, mean (SD) 7.8 (3.8) 7.8 (3.7) 0.65 6.9 (3.5) 6.8 (3.5) 0.30 1c First HbA ≤48mmol/mol, n (%) 62 (21.6) 46 (23.2) 0.74 79 (44.4) 76 (58.5) 0.016 1c Preconception folic acid n =288 n =195 n =164 n =123 Preconception folic acid any dose, n (%) 185 (64.2) 126 (64.6) 1.00 60 (36.6) 60 (48.9) 0.041 Preconception folic acid 5 mg dose daily , n (%) 174 (60.6) 113(58.0) 0.57 38(23.5) 51(41.8) 0.001 Potentially harmful medication n =274 n =204 n =169 n =131 On at least one potentially harmful medication , n (%) 10 (3.7) 3 (1.5) 0.17 27 (16.0) 16 (12.2) 0.41 Two or more potentially harmful medications, n (%) 0 (0) 0 (0) – 7 (4.1) 2 (1.5) 0.31 Optimal pregnancy preparation 0.086 0.021 nn =236 n =190 n =138 n =119 n (%) 25 (10.6) 31 (16.3) 8 (5.8) 18 (15.1) n values are shown below for the number of participants for which these data were available for each category of measures or each individual measure n values for numbers of participants with data for 5 mg daily dose of folic acid are 287 (type 1 diabetes before PPC); 195 (type 1 diabetes during/after PPC); 162 (type 2 diabetes before PPC); 122 (type 2 diabetes during/after PPC) Potentially harmful medications include secretagogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, thiazolidinedione, angiotensin converting enzyme inhibitor / angiotensin receptor blockers and statin Optimal pregnancy preparation defined as first HbA ≤48 mmol/mol (6.5%), on folic acid 5mg daily prior to last menstrual period, booking at ≤8 1c weeks gestation and no harmful medications prior to last menstrual period 1534 Diabetologia (2018) 61:1528–1537 (23.5% before and 41.8% during/after PPC implementation; was effective for improving pregnancy outcomes but was fo- p = 0.001). There was almost a threefold improvement in ‘op- cused on specialist pre-pregnancy clinics and did not adequate- timal’ pregnancy preparation during/after PPC implementa- ly engage with primary care teams . With a 90% increase in tion in women with type 2 diabetes (5.8% before and 15.1% type 2 diabetes over 15 years and increasing numbers of youn- during/after PPC implementation; p = 0.021) (Table 3). ger women with type 2 diabetes, primary care practitioners Overall, 16% of women with pregestational diabetes were (nurses and family physicians) are increasingly providing rou- considered ‘optimally’ prepared for pregnancy during/after tine diabetes care . This programme was primarily focused implementation (ESM Table 2). There was no change in the on raising awareness about the importance of safe, effective proportion of women with type 2 diabetes taking potentially contraception and/or PPC among primary care teams. harmful medications (16% before and 12.2% during/after PPC Measures such as improvement in folic acid preparation implementation; p =0.41). associated with the previous PPC programme have been main- tained over the decade since it was first introduced . Pregnancy outcomes Pregnancy outcomes for the 812 single- Specifically, 46% and 33% of women with type 1 and type ton pregnancies of women with type 1 and type 2 diabetes are 2 diabetes were on preconception folic acid between 2006 and showninTable 4. There were five perinatal deaths in type 1 2009, compared with 64% and 37% respectively prior to the diabetes pregnancies before (three stillbirths and two neonatal current intervention . Thus, there had been ongoing im- deaths) and none during/after PPC implementation. However, provements over time in type 1 diabetes but little or no change there were more congenital anomalies in type 1 diabetes off- in type 2 diabetes pregnancy. This programme demonstrated spring during/after PPC implementation, meaning that the over- clinically relevant improvements in type 2 diabetes pregnancy all rate of serious adverse pregnancy outcome was unchanged. with 49% of women with type 2 diabetes now taking precon- There were no differences in most perinatal morbidity out- ception folic acid. comes before and during/after PPC implementation. There Using the same definitions and data collection procedures was evidence for an overall increase in neonatal intensive care allows us to directly compare our findings with the NPID unit admissions (40.4% before vs 48.9% during/after PPC audit of women with pregestational diabetes in England and implementation; p = 0.022), which is likely due to a trend Wales. Only 15% and 38% of women with type 1 and type 2 towards earlier obstetric intervention (29.7% vs 36.1% pre- diabetes in NPID achieved first trimester HbA <48mmol/ 1c term delivery <37 weeks gestation; p =0.071) (ESM mol (6.5%) . In our study, 23% and 58% of women with Table 3). This was driven mainly by a higher proportion of type 1 and type 2 diabetes, respectively, achieved NICE guide- type 1 diabetes neonates requiring advanced neonatal care line HbA targets during the PPC programme. Similar im- 1c (46.6% before vs 56.7% during/after PPC implementation; provements were seen with 5 mg daily folic acid supplemen- p =0.022) (Table 4). tation, with 42% and 23% of women with type 1 and type 2 diabetes in NPID, compared with 58% and 42%, respectively, during our study. This is almost double the national rates for Discussion pre-pregnancy folic acid supplementation in type 2 diabetes pregnancy. Finally, only one in 12 women nationally were We report on a pragmatic community-based PPC programme considered well prepared for pregnancy (defined as HbA 1c that is simple and effective in improving pregnancy prepara- <48mmol/mol (6.5%), 5 mg folic acid daily and no harmful tion in women with type 2 diabetes. Almost 75% of primary medications). In our study, one in seven women with pre- care centres were actively engaged in identifying women with existing diabetes were considered optimally prepared for preg- diabetes and sending them information about sex, contracep- nancy, which included a more stringent criterion of booking tion and pregnancy. Significant improvements in pregnancy before 8 weeks’ gestation. preparation were seen in women with type 2 diabetes with In our study, more substantial improvements in pregnancy almost 60% reaching target HbA at conception, and 50% preparation were observed in type 2 diabetes compared with 1c taking preconception folic acid. Although most women type 1 diabetes. There may be many reasons for this differ- (85%) with type 2 diabetes were not optimally prepared for ence. First, our programme targeted primary care practitioners pregnancy, there was an overall threefold improvement in and community healthcare teams, which would have had a pregnancy preparation measures. Women with type 1 diabetes bigger impact on women with type 2 diabetes who are more had higher than average rates of folic acid supplementation likely to receive their care in a community setting . Second, before and during/after with the only significant difference women with type 2 diabetes tend to have a shorter duration of being earlier presentation for antenatal care during and after diabetes and a less severe glycaemic disturbance. They can be implementation of the PPC programme. treated more effectively with oral agents and are more likely to This community-based PPC programme was developed to reach target HbA than women with type 1 diabetes. Finally, 1c address the limitations of a previous regional programme which women with type 2 diabetes are more likely to be prescribed Diabetologia (2018) 61:1528–1537 1535 Table 4 Pregnancy outcomes before and during/after implementation of PPC programme by type of diabetes Type 1 diabetes Type 2 diabetes Before PPC During/after PPC p value Before PPC During/after PPC p value a a a a n=302 n=202 n=183 n=131 Pregnancy outcome n =302 n =202 n =183 n =131 Live birth, n (%) 278 (92.1) 187 (92.6) 0.87 172 (94.0) 123 (93.9) 1.00 Miscarriage, n (%) 18 (6.0) 14 (6.9) 0.71 8 (4.4) 5 (3.8) 1.00 Termination, n (%) 3 (1.0) 1 (0.5) 0.65 2 (1.1) 0 (0) 0.51 Delivery n =277 n =187 n =169 n =126 Gestational age at delivery, mean (SD) 36.8 (2.2) 36.9 (1.7) 0.90 37.4 (1.9) 37.3 (1.75) 0.49 Prematurity <37 weeks, n (%) 98(35.4) 79(42.3) 0.15 35(20.7) 35(27.8) 0.17 <34 weeks, n (%) 26 (9.4) 12 (6.4) 0.30 8 (4.7) 4 (3.2) 0.57 Birthweight (g) 0.43 0.85 nn =280 n =185 n =173 n =126 mean (SD) 3379.7 (700.0) 3429.6 (618.5) 3235.2 (665.5) 3249.7 (655.1) Infant birth centiles n =275 n =185 n =169 n =126 Large for gestational age, n (%) 121 (44.0) 86 (46.5) 0.63 32 (18.9) 28 (22.2) 0.56 Extremely large for gestational age, n (%) 80(29.1) 59(31.9) 0.54 17(10.1) 14(11.1) 0.84 Small for gestational age, n (%) 15 (5.5) 8 (4.3) 0.67 29 (17.2) 14 (11.1) 0.18 Advanced neonatal care 0.037 0.21 nn =277 n =187 n =172 n =123 n (%) 129 (46.6) 106 (56.7) 53 (30.8) 47 (38.2) Other pregnancy outcomes Congenital malformation 0.084 0.72 nn =267 n =177 n =168 n =121 n (%) 10 (3.8) 14 (7.9) 4 (2.4) 4 (3.3) Stillbirth 0.28 0.31 nn =281 n =187 n =173 n =126 n (%) 3 (1.1) 0 (0) 1 (0.6) 3 (2.4) Neonatal death 0.52 1.00 nn =269 n =176 n =166 n =112 n (%) 2(0.74) 0(0) 1(0.6) 0(0) Perinatal mortality 0.16 0.40 nn =272 n =176 n =167 n =115 n (%) 5 (1.8) 0 (0) 2 (1.2) 3 (2.6) n =259 n =171 n =163 n =113 Serious adverse outcome , n (%) 14 (5.4) 14 (8.2) 0.32 6 (3.7) 7 (6.2) 0.39 n values are shown for the number of participants for which these data were available for each category of measures or each individual measure Reported on all singleton pregnancies Reported on live and stillbirths Large for gestational age >90th centile, extremely large for gestational age >97.7th centile, small for gestational age <10th centile as per GROW customised centiles Serious adverse outcome: malformation with or without termination of pregnancy, stillbirth or neonatal death medications for hypertension and lipid lowering, offering an compared favourably to national data, but optimising achievable target for improvement in overall pregnancy prep- glycaemic control remains a major hurdle. The recent aration . randomised controlled trial of continuous glucose monitoring In contrast, in women with type 1 diabetes, the rates of folic (CONCEPTT) highlighted that even with high rates of con- acid supplementation and early presentation for antenatal care tinuous glucose monitoring and insulin pump use, only about 1536 Diabetologia (2018) 61:1528–1537 50% of women attending specialist PPC clinics were able to hypothesise that the systematic provision of information to all attain target HbA levels . It also described a high pro- women with diabetes, the face-to-face contact with primary 1c portion (60%) of women with type 1 diabetes who were over- care teams and the electronic preconception care templates weight and obese before pregnancy. Our data suggested an are all relevant. The uptake of other aspects such as the specific increase in body weight and maternal BMI, even over the preconception care module of the online education programme course of the programme, with an average 2.4 kg and 0.8 was disappointing. Our study was likely not large enough or of BMI point increase, even though women were entering preg- long-enough duration to detect differences in pregnancy out- nancy at a younger age. Interestingly, there were no such comes which would have required 580 pregnancies in the changes in women with type 2 diabetes. There is an unmet follow-up period to detect 30% reduction in serious adverse need to develop evidence-based dietary advice and weight- outcomes . Unfortunately, the limited funding arrangements management guidelines for women with type 1 and type 2 did not allow a longer duration of follow up. Because we com- diabetes. pare the programme before and during/after, we are unable to While overall pregnancy preparation improved after the comment on overall rates of PPC attendance and their relation implementation of our programme, 84% of women with to pregnancy outcomes. However, this is a pragmatic approach pregestational diabetes are still not ‘optimally’ prepared for to assessing the programme’s effectiveness. Furthermore, we pregnancy. This highlights that much more needs to be done. are not confounded by potential differences in women who If the programme had been continued for a longer period, may and may not seek PPC. We lack information on other more women may have benefitted. Ideally it would be imple- important confounders including diabetes duration, smoking mented over at least 12–24 months, to allow for maximum and social disadvantage. participation before assessing its impact. Improvements in the PPC remains an area of diabetes care in which measurable use of safe, effective contraception and in folic acid supple- improvements are achievable. We must continue to develop mentation for women not using appropriate contraception and implement strategies such as electronic preconception should be prioritised in primary care. Also, further improve- care templates that improve the uptake of safe, effective ments would be achieved if women with type 2 diabetes and methods of contraception and/or access to PPC for all women healthcare teams were more aware of the importance of im- with diabetes. The suboptimal glycaemic control and rising mediate referral for antenatal care following confirmation of rates of obesity in type 1 diabetes also require attention. pregnancy. In specialist care, more attention is required in These types of programmes should be funded, implemented helping women optimise glycaemic control. and studied in additional settings and populations. Our study has some important strengths. We describe an Acknowledgements We would like to acknowledge the tremendous work intervention that was simple, inexpensive, sustainable and done by the interdisciplinary pre-pregnancy team including E. Page (The easily reproducible in other regions. It was performed over a Ipswich Diabetes Centre, Ipswich Hospital NHS Trust, UK), S. Mitchell short time (only 17 months), with no substantial changes to (The Ipswich Diabetes Centre, Ipswich Hospital NHS Trust, UK), clinical practice guidelines and/or diabetes technology use and L. Dorsett (Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospitals NHS Foundation Trust [NNUH], UK), no documented changes in national pregnancy preparation as H. Cobb (Department of Diabetes and Endocrinology, NNUH, UK), recorded by the same NPID measures from 2014 to 2016 . L. Newdick (Department of Diabetes and Endocrinology, West Suffolk, Thus, the improvements seen with the initiation of our pro- UK), S. Cooper (Department of Diabetes and Endocrinology, West gramme are unlikely related to wider changes in the care of Suffolk, UK), K. Moore Haines (East and North Hertfordshire NHS Trust, UK), S. Woodley (East and North Hertfordshire NHS Trust, UK), women with diabetes. We were able to demonstrate a benefit J. Curtis (Wolfson Diabetes and Endocrine Clinic, Cambridge University of this programme despite the existing regional programme Hospitals NHS Foundation trust [CUHFT], UK), H. Jacobs (Wolfson and above average baseline measures of pregnancy prepara- Diabetes and Endocrine Clinic, CUHFT, UK), A. Rowley (Wolfson Diabetes and Endocrine Clinic, CUHFT, UK), E. Birbeck (Colchester tion compared with NPID. Finally, it was simple to establish Hospital University NHS Foundation Trust, Colchester, UK). We thank and was achieved at a very modest cost of less than £50,000 also Z. Stewart (Wellcome Trust–Medical Research Council Institute of per year. The 2014 National Reference Costs for the lifetime Metabolic Science, University of Cambridge, Cambridge, UK) and col- specialist health care costs for each congenital anomaly were leaguesatJeanHailes(https://jeanhailes.org.au/), Melbourne, Australia, for their assistance in revamping the PPC leaflet. estimated as £668,098 for neural tube defects, £434,340 for cardiac malformations, £82,972 for gastrointestinal defects Data availability Further details of the data collection methodology, and £47,160 for cleft lip and palate (personal communication, individual clinic data and the full audit reports for healthcare professionals P. King, Royal Derby Hospitals NHS Foundation Trust, and service users are available from https://digital.nhs.uk/data-and- information/clinical-audits-and-registries/our-clinical-audits-and-registries/ Derby, UK), suggesting that prevention of one cleft lip and national-pregnancy-in-diabetes-audit. palate would cover the programme costs. However, our study also has limitations. Because our pro- Funding The EAHSN (www.eahsn.org), which funded this project, is one gramme was multifaceted, we are unable to comment on which of 15 academic health science networks in England, established to spread component of the programme was most effective. We innovative services at scale and pace; and to connect academic Diabetologia (2018) 61:1528–1537 1537 organisations, NHS organisations and local authorities to improve 4. National Institute for Health and Care Excellence (2015) Diabetes outcomes—and variance in outcomes—for patients. The EAHSN covers a in pregnancy: management from preconception to the postnatal population of 4.45 million, with an estimated 271,000 people with diabetes. period. Available from https://www.nice.org.uk/guidance/ng3 HRM conducts independent research supported by the National Institute 5. Murphy HR, Roland JM, Skinner TC et al (2010) Effectiveness of a for Health Research (CDF-2013-06-035). Theviewsexpressedinthis regional prepregnancy care program in women with type 1 and type publication are those of the authors and not necessarily those of the 2 diabetes: benefits beyond glycemic control. Diabetes Care 33: NHS, the National Institute for Health Research (NIHR) or the UK 2514–2520 Department of Health. HRM has also received grant income from the 6. Egan AM, Danyliv A, Carmody L, Kirwan B, Dunne FP (2016) A UK Efficacy Mechanism Evaluation (EME) programme (funded by the prepregnancy care program for women with diabetes: effective and Medical Research Council and NIHR), Diabetes UK, JDRF International cost saving. J Clin Endocrinol Metab 101:1807–1815 and the Diabetes Research & Wellness Foundation (DRWF). JMY is 7. Wahabi HA, Alzeidan RA, Bawazeer GA, Alansari LA, Esmaeil supported by the Allen-Carey Scholarship in Women’sHealth. The SA (2010) Preconception care for diabetic women for improving funders had no role in study design, data collection and analysis, decision maternal and fetal outcomes: a systematic review and meta-analy- to publish or preparation of the manuscript. sis. BMC Pregnancy Childbirth 10:63 8. Murphy HR, Steel SA, Roland JM et al (2011) Obstetric and peri- natal outcomes in pregnancies complicated by type 1 and type 2 Duality of interest HRM serves on the Medtronic European Scientific diabetes: influences of glycaemic control, obesity and social disad- Advisory Board. vantage. Diabet Med 28:1060–1067 9. Canadian Diabetes Association Clinical Practice Guidelines Expert Contribution statement HRM, MJS, MLE, VK, JDAC, NJM, GAR, Committee, Thompson D, Berger H et al (2013) Diabetes and preg- PHW, CH and AWH conceived and designed the study. DJFH collected nancy. Can J Diabetes 37(Suppl 1):S168–S183 the data. JMY analysed the data. JMY and HRM interpreted the data. 10. American Diabetes Association (2017) 13. Management of diabetes JMY wrote the first draft of the manuscript. All authors participated in in pregnancy. Diabetes Care 40(Suppl 1):S114–S119 the critical revision of the manuscript and approved the final version. 11. Makda SI, Davies MJ, Wilmot E et al (2013) Prescribing in preg- HRM is the guarantor of this work, had full access to all the study data nancy for women with diabetes: use of potential teratogenic drugs and takes responsibility for the integrity of the data. and contraception. Diabet Med 30:457–463 12. Klein J, Boyle JA, Kirkham R et al (2017) Preconception care for women with type 2 diabetes mellitus: a mixed-methods study of Open Access This article is distributed under the terms of the Creative provider knowledge and practice. Diabetes Res Clin Pract 129: Commons Attribution 4.0 International License (http:// 105–115 creativecommons.org/licenses/by/4.0/), which permits use, duplication, 13. Forde R, Patelarou EE, Forbes A (2016) The experiences of adaptation, distribution and reproduction in any medium or format, as prepregnancy care for women with type 2 diabetes mellitus: a me- long as you give appropriate credit to the original author(s) and the ta-synthesis. 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Diabetologia – Springer Journals
Published: May 9, 2018
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