Improving women's lifelong health after high-risk pregnancy

Cardiovascular diseases (CVDs), such as strokes and heart attacks, are the leading causes of death amongst women globally. A particular group of women at high risk of cardiovascular disease are those who experience a pregnancy complicated by gestational diabetes mellitus (GDM) and/or a hypertensive disorder of pregnancy (HDP). Following a pregnancy affected by GDM, within 5 years up to 50% of women will develop T2DM; and following HDP, 30% of women will develop hypertension. Both these conditions greatly increase risk for CVD, however with timely detection and management these risks can be greatly reduced. The importance of breaking this link between high-risk pregnancy and CVD is widely acknowledged, yet to date there have been no trials demonstrating this can be achieved, and importantly whether it can be done affordably and at scale. Three key actions are needed: (i) effective primary prevention; (ii) regular screening, and (iii) evidence-based management when disease is detected.

India is experiencing an epidemic of type 2 diabetes mellitus (T2DM) and hypertension. 73 million people have diabetes, and 207 million hypertension (2017 data). Rates of GDM and HDP are high, affecting 20% and 10% of pregnancies, respectively. There is an urgent need for effective and affordable preventative strategies to reduce the economic, social and health consequences of these conditions for women in India.

In the UK, GDM and HDP are the commonest complications of pregnancy. After a pregnancy with GDM, women should undergo screening with their GP 6 week after birth for persistent high blood glucose. Attendance however is generally poor, with rates between 30-70% across the country. Following HDP, evidence is needed to guide care.

The Fellowship will enable me to lead connected programs of work across two countries: India and the UK, determining the role digital innovations could play to deliver post-partum interventions in women globally. I will conduct two clinical studies, with active engagement with policy makers, clinicians, digital health companies and social enterprises throughout the Fellowship.

SMART Health is a digital platform, developed by the George Institute for Global Health, that has been implemented in India, Indonesia, China, and Myanmar, to improve detection and management of diabetes and hypertension. The platform is aimed at rural community health workers and primary care doctors, enabling task shifting, clinical decision support, automated referral, SMS reminders, and patient tracking. Since 2017, I have been leading the group adapting this platform to improve the detection and management of anaemia, GDM and HDP in pregnant women living in rural India: SMART Health Pregnancy (SHP). Through this Fellowship I will extend SHP to facilitate prevention, screening, and early treatment of hypertension and T2DM in the years after a pregnancy complicated by GDM and/or HDP. The effect of this on achieving target blood pressure and blood glucose control after high risk pregnancy will be assessed in a large clinical trial in rural India, following 960 women for 5 years.

In the UK, I was part of the team of clinicians and researchers in Oxford who developed a remote monitoring system for women with GDM (GDmHealth). We demonstrated in a clinical trial that this approach was safe, convenient and preferred by women and health workers. The technology was licensed to a commercial company (Sensyne) in 2018, and since then thousands of women have benefited from this innovation across the UK. Through this Fellowship I will lead a program of work adapting this approach for women in the year after birth, assessing whether remote monitoring improves screening attendance, deliver effective lifestyle support, offer a potential cost savings to the NHS, whilst being acceptable and more convenient for new mums. Theis approach could improve their health, for future pregnancies and lifelon

India impact:
- Short term: Women and their families participating will directly benefit with improvements in their health and wellbeing. A major challenge in the Indian sites is the low status of women in rural communities. Through local public awareness campaigns we hope to promote the status of women, valuing women's health through the life course, and work with communities to create enabling environments for changing attitudes to gender and health.
- Community health workers and primary care doctors will benefit through educational activities, directly impacting patient care during and after the study.
- Short term impact from the policy symposia will be raised awareness within the target groups, with ultimate impact being adoption of a practical and feasible policy for postpartum surveillance and care, to be adopted within 8 years.
- Evidence moving from the pilot study (currently underway) to the larger trial proposed will impact research design and conduct in this setting in the future. I will build research capacity in India, helping team members further their own programs of research in India beyond the Fellowship.
- Longer term: Given in India approximately 25 million babies are born each year and up to 20% of pregnant women will have either GDM or HDP, a 15% improvement in on-target blood glucose or blood pressure in the high-risk group could improve the lives of up to 500 000 women each year, with substantial longer term wider economic and societal benefits as CVD or other complications are averted.

UK impact
- Short term: Women participating in the feasibility study will benefit from the increased preventative health advice and the opportunity to link with other new mums through a social network. This will boost their capacity to make positive lifestyle changes, with immediate and medium-term impacts on their health and wellbeing. If we proceed to the larger, definitive trial, women who receive the intervention will benefit from the above, as well as avoiding the 6-week GP check. This will be cost saving for the NHS if scaled (currently these appointments cost the NHS approx £1M per year).
- The UK roundtable will bring together key groups to discuss what is needed to improve screening rates and women's lives. The impact of this meeting will be formation of a research consortium, to gain competitive funding to conduct the larger definitive trial.
- Longer term: Evidence generated through this research will be used in the formulation of updates to UK clinical guidelines (NICE guidelines 3 and 133), Quality standards in these guidelines are used to benchmark maternity services. If remote monitoring is effective, this could change the way women engage with the health system after birth for other conditions, such as mental health, providing an exemplar of an integrated and evidence-based remote monitoring system.
Global policy impact
- This fellowship will directly provide evidence to update the FIGO initiative on GDM (2015) and the WHO recommendations on postnatal care of the mother and newborn (2013)

Academic impact:
- This will be of interest to academics (outlined in the beneficiaries statement), as well as groups calling on a focus on the specific needs of women for CVD research, prevention and health care delivery, e.g. the Lancet Commission on Women's health and CVD, British Heart Foundation, Women Deliver and the NCD Alliance (see support letters). Longer term, all data will be open access and available to the research community (see data management plan)

Commercial impact
- The UK could become the world leader in digital technologies to support women during and after high-risk pregnancy, challenging current care delivery. GHE have extensive networks across Asia, with a ready market for expansion to the sites already using the SMART Health system. Sensyne work closely with the NHS and partners in the US (Jefferson Health), opening international commercial opportunities.