Introduction
Women with pregestational diabetes remain at increased risk of adverse pregnancy outcomes associated with suboptimal pregnancy preparation [
1,
2]. A large national cohort in the UK demonstrated that only 14% of women with type 1 diabetes and 37% of women with type 2 diabetes achieve the National Institute for Health and Care Excellence (NICE) guideline HbA
1c target of 48 mmol/mol (<6.5%) [
3,
4]. Furthermore, only 46% and 23% of women with type 1 and type 2 diabetes respectively, were taking 5 mg of folic acid daily prior to conception [
3]. This leaves much room for improvement.
Pre-pregnancy care (PPC) has been shown to improve pregnancy preparation measures such as preconception folic acid supplementation, periconception glycaemic control, avoiding potentially harmful medications and presenting for early antenatal care [
5‐
7]. We previously demonstrated that although women with type 2 diabetes have additional obstetric risk factors (higher age, parity, BMI) compared with women who have type 1 diabetes, PPC is as effective in reducing the risk of serious adverse pregnancy outcomes in type 2 as in type 1 diabetes [
5,
8]. Despite its well-established benefits and widespread recommendation, PPC attendance continues to be low [
4‐
6,
9,
10]. Even in regions with specialist programmes, only a third of women with type 2 diabetes attend PPC [
5,
6]. Conversely, the use of contraception also continues to be low, with less than half of women with type 1 and type 2 diabetes on potentially harmful prescribed medications using safe, effective methods of contraception [
11].
Most women with type 2 diabetes have routine care in primary care settings, where awareness of the specific issues of diabetes pregnancy preparation is limited [
8,
12]. This leads to low levels of awareness regarding the importance of safe, effective contraception to avoid an unintended pregnancy and of PPC in women who are thinking about trying for a baby. Women with type 2 diabetes are more likely to live in areas of socioeconomic deprivation and belong to ethnic minority groups so may have additional financial, cultural and ethnic barriers to accessing healthcare [
8,
12].
Qualitative interviews suggested that women with type 2 diabetes had common misconceptions about their reproductive potential [
13,
14], thinking it was ‘harder to conceive’ with poorly controlled diabetes and high BMI [
13,
14]. Some overweight and obese women were advised that they had ‘too many risk factors’ for hormonal contraception. Others reported concerns regarding the negative views of women with type 2 diabetes and pre-pregnancy discussions [
13,
15]. Information about diabetes pregnancy was seen as too ‘risk-focused’ and ‘alarming’, concentrating on ‘all the bad things that could happen’ [
14]. Women stated a preference for clear practical advice about sex and diabetes with less emphasis on ‘preconception and having a baby’ [
14].
There is an unmet need to improve women’s and healthcare professionals’ awareness about diabetes pregnancy risks and how they can be minimised by optimal pregnancy preparation [
8]. To address this, we developed and implemented an integrated community-based PPC programme for women with pregestational diabetes (type 1, type 2 and other), focusing on engaging primary care diabetes teams. This study assesses its effectiveness on pregnancy preparation measures and pregnancy outcomes in women with pre-existing diabetes. We hypothesised that a community-based PPC programme would improve pregnancy preparation in women with type 2 diabetes.
Methods
A multifaceted approach was taken to engage women with diabetes (type 1, type 2 and other, including MODY) as well as their primary healthcare providers, including primary care practitioners and community healthcare teams in the Eastern Academic Health Science Network (EAHSN) (see electronic supplementary material [
ESM] for details of participating clinical commissioning groups [CCGs]). This included identifying and sending theoretically guided (balancing the risk of unattended pregnancy and benefits of pregnancy preparation) patient information leaflets to all eligible women (ESM Fig.
1), providing preconception care templates for use during face-to-face primary care visits (ESM Fig.
2), providing online PPC education modules and resources, as well as participating in a series of regional and local educational events for patients and healthcare professionals. The NPID patient information leaflet and consent form met the Health Research Authority requirements for clinical audit, and research ethics approval was not required.
Discussion
We report on a pragmatic community-based PPC programme that is simple and effective in improving pregnancy preparation in women with type 2 diabetes. Almost 75% of primary care centres were actively engaged in identifying women with diabetes and sending them information about sex, contraception and pregnancy. Significant improvements in pregnancy preparation were seen in women with type 2 diabetes with almost 60% reaching target HbA1c at conception, and 50% taking preconception folic acid. Although most women (85%) with type 2 diabetes were not optimally prepared for pregnancy, there was an overall threefold improvement in pregnancy preparation measures. Women with type 1 diabetes had higher than average rates of folic acid supplementation before and during/after with the only significant difference being earlier presentation for antenatal care during and after implementation of the PPC programme.
This community-based PPC programme was developed to address the limitations of a previous regional programme which was effective for improving pregnancy outcomes but was focused on specialist pre-pregnancy clinics and did not adequately engage with primary care teams [
5]. With a 90% increase in type 2 diabetes over 15 years and increasing numbers of younger women with type 2 diabetes, primary care practitioners (nurses and family physicians) are increasingly providing routine diabetes care [
17]. This programme was primarily focused on raising awareness about the importance of safe, effective contraception and/or PPC among primary care teams.
Measures such as improvement in folic acid preparation associated with the previous PPC programme have been maintained over the decade since it was first introduced [
5]. Specifically, 46% and 33% of women with type 1 and type 2 diabetes were on preconception folic acid between 2006 and 2009, compared with 64% and 37% respectively prior to the current intervention [
5]. Thus, there had been ongoing improvements over time in type 1 diabetes but little or no change in type 2 diabetes pregnancy. This programme demonstrated clinically relevant improvements in type 2 diabetes pregnancy with 49% of women with type 2 diabetes now taking preconception folic acid.
Using the same definitions and data collection procedures allows us to directly compare our findings with the NPID audit of women with pregestational diabetes in England and Wales. Only 15% and 38% of women with type 1 and type 2 diabetes in NPID achieved first trimester HbA
1c <48mmol/mol (6.5%) [
18]. In our study, 23% and 58% of women with type 1 and type 2 diabetes, respectively, achieved NICE guideline HbA
1c targets during the PPC programme. Similar improvements were seen with 5 mg daily folic acid supplementation, 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 pre-pregnancy folic acid supplementation in type 2 diabetes pregnancy. Finally, only one in 12 women nationally were considered well prepared for pregnancy (defined as HbA
1c <48mmol/mol (6.5%), 5 mg folic acid daily and no harmful medications). In our study, one in seven women with pre-existing diabetes were considered optimally prepared for pregnancy, which included a more stringent criterion of booking before 8 weeks’ gestation.
In our study, more substantial improvements in pregnancy preparation were observed in type 2 diabetes compared with type 1 diabetes. There may be many reasons for this difference. First, our programme targeted primary care practitioners and community healthcare teams, which would have had a bigger impact on women with type 2 diabetes who are more likely to receive their care in a community setting [
8]. Second, women with type 2 diabetes tend to have a shorter duration of diabetes and a less severe glycaemic disturbance. They can be treated more effectively with oral agents and are more likely to reach target HbA
1c than women with type 1 diabetes. Finally, women with type 2 diabetes are more likely to be prescribed medications for hypertension and lipid lowering, offering an achievable target for improvement in overall pregnancy preparation [
8].
In contrast, in women with type 1 diabetes, the rates of folic acid supplementation and early presentation for antenatal care compared favourably to national data, but optimising glycaemic control remains a major hurdle. The recent randomised controlled trial of continuous glucose monitoring (CONCEPTT) highlighted that even with high rates of continuous glucose monitoring and insulin pump use, only about 50% of women attending specialist PPC clinics were able to attain target HbA
1c levels [
19]. It also described a high proportion (60%) of women with type 1 diabetes who were overweight and obese before pregnancy. Our data suggested an increase in body weight and maternal BMI, even over the course of the programme, with an average 2.4 kg and 0.8 BMI point increase, even though women were entering pregnancy at a younger age. Interestingly, there were no such changes in women with type 2 diabetes. There is an unmet need to develop evidence-based dietary advice and weight-management guidelines for women with type 1 and type 2 diabetes.
While overall pregnancy preparation improved after the implementation of our programme, 84% of women with pregestational diabetes are still not ‘optimally’ prepared for pregnancy. This highlights that much more needs to be done. If the programme had been continued for a longer period, more women may have benefitted. Ideally it would be implemented over at least 12–24 months, to allow for maximum participation before assessing its impact. Improvements in the use of safe, effective contraception and in folic acid supplementation for women not using appropriate contraception should be prioritised in primary care. Also, further improvements would be achieved if women with type 2 diabetes and healthcare teams were more aware of the importance of immediate referral for antenatal care following confirmation of pregnancy. In specialist care, more attention is required in helping women optimise glycaemic control.
Our study has some important strengths. We describe an intervention that was simple, inexpensive, sustainable and easily reproducible in other regions. It was performed over a short time (only 17 months), with no substantial changes to clinical practice guidelines and/or diabetes technology use and no documented changes in national pregnancy preparation as recorded by the same NPID measures from 2014 to 2016 [
18]. Thus, the improvements seen with the initiation of our programme are unlikely related to wider changes in the care of women with diabetes. We were able to demonstrate a benefit of this programme despite the existing regional programme and above average baseline measures of pregnancy preparation compared with NPID. Finally, it was simple to establish and was achieved at a very modest cost of less than £50,000 per year. The 2014 National Reference Costs for the lifetime specialist health care costs for each congenital anomaly were estimated as £668,098 for neural tube defects, £434,340 for cardiac malformations, £82,972 for gastrointestinal defects and £47,160 for cleft lip and palate (personal communication, P. King, Royal Derby Hospitals NHS Foundation Trust, Derby, UK), suggesting that prevention of one cleft lip and palate would cover the programme costs.
However, our study also has limitations. Because our programme was multifaceted, we are unable to comment on which component of the programme was most effective. We hypothesise that the systematic provision of information to all women with diabetes, the face-to-face contact with primary care teams and the electronic preconception care templates are all relevant. The uptake of other aspects such as the specific preconception care module of the online education programme was disappointing. Our study was likely not large enough or of long-enough duration to detect differences in pregnancy outcomes which would have required 580 pregnancies in the follow-up period to detect 30% reduction in serious adverse outcomes [
5]. Unfortunately, the limited funding arrangements did not allow a longer duration of follow up. Because we compare the programme before and during/after, we are unable to comment on overall rates of PPC attendance and their relation to pregnancy outcomes. However, this is a pragmatic approach to assessing the programme’s effectiveness. Furthermore, we are not confounded by potential differences in women who may and may not seek PPC. We lack information on other important confounders including diabetes duration, smoking and social disadvantage.
PPC remains an area of diabetes care in which measurable improvements are achievable. We must continue to develop and implement strategies such as electronic preconception care templates that improve the uptake of safe, effective methods of contraception and/or access to PPC for all women with diabetes. The suboptimal glycaemic control and rising rates of obesity in type 1 diabetes also require attention. These types of programmes should be funded, implemented and studied in additional settings and populations.
Acknowledgements
We would like to acknowledge the tremendous work done by the interdisciplinary pre-pregnancy team including E. Page (The Ipswich Diabetes Centre, Ipswich Hospital NHS Trust, UK), S. Mitchell (The Ipswich Diabetes Centre, Ipswich Hospital NHS Trust, UK), L. Dorsett (Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospitals NHS Foundation Trust [NNUH], UK), H. Cobb (Department of Diabetes and Endocrinology, NNUH, UK), L. Newdick (Department of Diabetes and Endocrinology, West Suffolk, UK), S. Cooper (Department of Diabetes and Endocrinology, West Suffolk, UK), K. Moore Haines (East and North Hertfordshire NHS Trust, UK), S. Woodley (East and North Hertfordshire NHS Trust, UK), J. Curtis (Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation trust [CUHFT], UK), H. Jacobs (Wolfson Diabetes and Endocrine Clinic, CUHFT, UK), A. Rowley (Wolfson Diabetes and Endocrine Clinic, CUHFT, UK), E. Birbeck (Colchester Hospital University NHS Foundation Trust, Colchester, UK). We thank also Z. Stewart (Wellcome Trust–Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK) and colleagues at Jean Hailes (
https://jeanhailes.org.au/), Melbourne, Australia, for their assistance in revamping the PPC leaflet.