Improving women's lifelong health after high-risk pregnancy

Lead Research Organisation: University of Oxford
Department Name: Women s and Reproductive Health


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

Planned Impact

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.


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Ayman G (2021) The top 10 research priorities in diabetes and pregnancy according to women, support networks and healthcare professionals. in Diabetic medicine : a journal of the British Diabetic Association

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Bonell A (2023) A feasibility study of the use of UmbiFlow™ to assess the impact of heat stress on fetoplacental blood flow in field studies. in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

Description We have developed a new way to improve the delivery of guideline-based screening and management for pregnant and recently pregnant women in India using an approach called SMART Health Pregnancy. SMART Health Pregnancy supports frontline community health workers (known as ASHA workers in India) to perform screening for high blood pressure, anaemia and diabetes in women's homes. Importantly the system automatically refers and links women with doctors at the primary care centre, who are also supported with a tablet App and can then prescribe guideline-based management. The system was co-designed with users and focusses on the three most common maternal medical conditions in rural India: anaemia, preeclampsia and diabetes.

To date the team have completed the SMART Health Pregnancy pilot cluster randomised trial in four sites in rural India during 2019-2020. The pilot study involved 200 pregnant women and 50 frontline health workers. SMART Health Pregnancy was demonstrated to be feasible and acceptable to women and frontline health workers. The pilot study demonstrated high rates of follow up women for up to 6 weeks after pregnancy, despite the COVID-19 restrictions in place in India in 2020.

We are now assessing the impact of this approach on pregnancy endpoints in a large cluster randomised trial in Telangana and Haryana in India. Identifier: NCT05752955

we have also begun a program of work to integrate mental health screening into the intervention (PRAMH: the Perinatal and Mental Health study). We have applied for funding from MRC PHIND to support the development of this new part of the intervention.
Exploitation Route The findings of this research are of interest to providers of maternal care in many resource-constrained areas around the world. Whilst we are still evaluating the effects on clinical endpoints, we have demonstrated that task shifting of screening during pregnancy is feasible and acceptable, and how digital tools can be used to strengthen quality of care.
Sectors Communities and Social Services/Policy,Digital/Communication/Information Technologies (including Software),Healthcare

Description Whilst our work is still in progress, supporting frontline health workers with digital tools to strengthen maternity care services is of great interest in many settings worldwide. Prof Hirst has been invited to speak at national Indian meetings about the work, which generated a lot of discussion amongst local specialists in diabetes and women's health. Dr S Nagraj completed her DPhil in 2021, summarising the findings of the pilot work, and this has been presented at the RCOG World Congress and other professional meetings. From the promising initial results, we are conducting a larger trial to assess whether the intervention can be effective in improving health outcomes and we are designing a perinatal mental health intervention based on the same SMART Health Approach, and hope to gain external peer-reviewed funding for this work in the next 12 months. In addition to this, I also lead a program of work in the UK exploring how digital technologies can be used to improve outcomes for women with gestational diabetes. We have published several proof of principal studies. In 2022 I convened a national roundtable in Oxford, where there is great interest in expanding this work and the consortium nationally.
First Year Of Impact 2021
Sector Digital/Communication/Information Technologies (including Software),Healthcare
Impact Types Policy & public services

Description Expert advisor on NICE Quality Standards Committee for Diabetes in Pregnancy
Geographic Reach National 
Policy Influence Type Participation in a guidance/advisory committee
Description NICE Diabetes Committee member
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact All women in NHS England are now eligible and are given support for CGM during pregnancy. Based on the CONCEPPT trial, this is anticipated to have significant cost savings and benefits with respect to NICU admission and neonatal outcomes.
Description RCOG Scientific Impact Statement on Social Determinants of Maternal Health
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Description A multidisciplinary roundtable on novel machine learning approaches for complex clinical data with a focus on improving care for women with Gestational Diabetes Mellitus
Amount £5,000 (GBP)
Organisation University of Southampton 
Department ESRC National Centre for Research Methods
Sector Charity/Non Profit
Country United Kingdom
Start 12/2022 
End 01/2023
Description WHo ICFP Scientific Writing, Menotring and Coaching Course
Amount $3,000 (USD)
Organisation World Health Organization (WHO) 
Sector Public
Country Global
Start 11/2022 
End 02/2023
Description Digital health in Africa 
Organisation University College Cork
Department Department of Epidemiology and Public Health
Country Ireland 
Sector Academic/University 
PI Contribution I am a member of the Scientific Advisory Committee for the Ultra project, which is a digital health initiative for maternity care in Tanzania
Collaborator Contribution regular convening of meetings, development of the intervention, testing the inervention, reviewing evidence, engaging with policy makers, seeking further funding options
Impact Publication: Cansdale et al 2022.
Start Year 2021
Description The George Institute for Global Health 
Organisation George Institute for Global Health
Department George Institute for Global Health (India)
Country India 
Sector Charity/Non Profit 
PI Contribution I have established the SMART Health Pregnancy program jointly with the University of Oxford and the George Institute for Global Health (TGIGH). My role has been in adapting the SMART Health intervention to address high-risk pregnancy conditions, with the aim of improving pregnancy outcomes and lifelong health. I have joined the UK team of TGIGH and regularly contribute to the development of their Global Women's Health Program, Better Care Program (focussed on improving access to quality primary care around the world) and multimobidity program. mY post doc, Dr Nicole Votruba is also an honorary research associate with TGIGH and is contributing to developing a perinatal mental health program which will run alongside the main intervention we are developing. I have contributed to TGIGH by giving seminars and representing the George Insitute and Univerisity of Oxford at events.
Collaborator Contribution TGIGH are a critical partner in developing and operationalising the research project "SMART Health Pregnancy." The George Institute for Global Health (TGI), with offices in Sydney, China, India and the UK, is a dynamic global research institute with the mission to improve the health of millions of people worldwide. The India team have large-scale trial expertise and have established trust with local communities, health providers and government, which is essential for research is to be successful. TGI have experts in health policy, digital health, health systems, health equity and primary care who are involved in the project. Partners at TGI have convened stakeholder meetings and run community engagement programs.
Impact 1.Nagraj, S., Kennedy, S., Jha, V.,..Hirst, J.E. (2021) SMARThealth Pregnancy: Feasibility and acceptability of a complex intervention for high-risk pregnant women in rural India: Protocol for a pilot cluster randomised controlled trial. Frontiers in Global Women's Health. Accepted May 3 2021. 2. Nagraj, S., Kennedy, S. H., Norton, R., Jha, V., Praveen, D., Hinton, L., & Hirst, J. E. (2020). Cardiometabolic Risk Factors in Pregnancy and Implications for Long-Term Health: Identifying the Research Priorities for Low-Resource Settings. FRONTIERS IN CARDIOVASCULAR MEDICINE, 7. doi:10.3389/fcvm.2020.00040 3. Hirst, J. E., Nagraj, S., Henry, A., Mackillop, L., Norton, R., & Kennedy, S. (2019). The obstetrician's role in preventing cardiometabolic disease. The Obstetrician & Gynaecologist, 21(4), 247-254. doi:10.1111/tog.12600 4. Nagraj, S., Hinton, L., Praveen, D., Kennedy, S., Norton, R., & Hirst, J. (2019). Women's and healthcare providers' perceptions of long-term complications associated with hypertension and diabetes in pregnancy: a qualitative study. BJOG: An International Journal of Obstetrics and Gynaecology, 126(S4), 34-42. doi:10.1111/1471-0528.15847 5. Convened and chaired two national workshops on non-communicable diseases and pregnancy in India, receiving national press coverage, New Delhi and Vijayawada, 2019
Start Year 2021
Title SMART Health Pregnancy 2: A Cluster Randomised Trial of a complex intervention to improve women's health in rural India 
Description Medical and nutritional complications in pregnancy affect the development of the fetus, risks around childbirth, and women's future health and wellbeing. Anaemia affects over 50% of pregnant women in India and reduction is a national priority. Women who develop gestational diabetes mellitus (GDM) or hypertensive disorders of pregnancy (HDP) are at significantly increased risk of pregnancy complications and future type 2 diabetes, hypertension or cardiovascular disease. SMART Health Pregnancy is a tool developed to improve guideline-based screening and management of anaemia, diabetes and hypertension during pregnancy and in the first year after birth. We have completed a 200- woman pilot and feasibility study and are now assessing the intervention across 60 villages (approx 3500 women) in two startes in India. This is a pragmatic, type 2 hybrid effectiveness/implementation cluster randomised controlled trial. The unit of randomisation will be the Primary Health Centre (PHC). The principle source of funding is the UKRI Future Leaders Fellowship. 
Type Health and Social Care Services
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2021
Development Status Under active development/distribution
Impact We have conducted national stakeholder workshops on high risk pregnancy conditions in India and are currently developing a perinatal mental health component. 
Description Convening a national workshop on data science and diabetes in pregnancy 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This Innovation Forum brought together a multidisciplinary group of 30 researchers, clinicians, machine learning data scientists, industry partners, NHS Digitial, and others to discuss the opportunities and challenges for improving clinical care using complex clinical data. The workshop focussed on one specific clinical challenge, Gestational Diabetes Mellitus (GDM), with consideration of other data science challenges and solutions in pregnancy care more widely and other clinical conditions.
The Forum was an opportunity to learn about specific data challenges researchers had experienced, learn from what has worked, and where further research is needed. We identified several opportunities for GDM data research in the UK, including the commissioning of the first national GDM audit and a need to focus on preventing type 2 diabetes after GDM in young women. The Forum identified six areas for future work and funding: (i) support for infrastructure to enable data science in this field; (ii) the need to map available data sources in the UK for pregnancy research; (iii) streamlined solutions for ethical approvals and regulatory support; (iv) improving data quality, linkage and access for researchers; (v) development of machine learning and statistical approaches; and (vi) the need to collaborate with clinicians, women and their families to make sure data science improves lives.
Year(s) Of Engagement Activity 2022
Description India Birth Network 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I was invited to attend the India Birth Network, an initiative led by the Liverpool School of Tropical Medicine and Christian Medical College, Vellore India. This was a 2-day meeting to network between UK and Indian researchers working in maternity research. Unfortunately due to COVID19, I was only able to attend virtually.
Year(s) Of Engagement Activity 2022
Description RCOG Social Determinants of Maternal Health Scientific Impact Statement Launch 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact This was a media release from the RCOG about the new SIP on social determinants of maternal health. It was promoted through RCOG and University social media
Year(s) Of Engagement Activity 2022