A third of women who develop high blood pressure or diabetes during pregnancy will go on to develop cardiovascular disease within a decade, yet almost no prevention trials target them after they give birth. This feasibility study tests whether a new approach can reach those women—particularly from ethnic minority and deprived communities—and keep them engaged. The researchers will recruit 162 women who had hypertensive disorders of pregnancy or gestational diabetes, plus a “study buddy” for each. After breastfeeding ends, participants are randomly assigned to take an SGLT2 inhibitor (a diabetes drug that also lowers blood pressure) for three or six months, or to receive standard care. All data collection happens at home: blood pressure cuffs, urine tests, and capillary blood samples are posted to participants, with remote monitoring via digital tools. Postpartum health champions recruited through midwifery networks provide peer support. If the trial proves feasible, it could pave the way for larger studies that prevent hypertension and type 2 diabetes in women who are currently missed by conventional healthcare. The ultimate goal is to reduce cardiovascular deaths in the groups that bear the highest burden of disease.
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Background Cardiovascular disease (CVD) causes the highest number of preventable deaths in the UK, with high rates in ethnic minority groups and with socioeconomic deprivation. Pre-disposition to future cardiovascular and metabolic complications is revealed in ~10% of UK pregnancies thus provides an opportunity to a) identify women at greatest CVD risk b) provide early CVD prevention c) improve future pregnancy outcomes. Engagement of postpartum women is challenging, particularly for ethnic minorities and deprived communities. New strategies to support participation in under-served communities are needed. PPI groups suggested 'postpartum health champions', 'study-buddies' and supported home point-of-care and digital-data collection to improve uptake, but optimisation of these approaches is needed. Sodium-Glucose-Transporter-2 inhibitors (SGLT2i) improve blood pressure (BP) and insulin resistance, thus are potential agents to prevent onset of diabetes and hypertension but have limited study pre-disease. Overall Aim: - To optimise methodologies and collect data to inform future community-based point-of-care, digital and peer-supported trials, with enhanced recruitment from under-served communities. Objectives - To assess feasibility of a randomised openlabel study of SGLT2i in postpartum women and 'study-buddies' with risk factors for CVD compared with standard care, with peer-support and remote monitoring - To determine adaptations to meet the needs of different underserved communities (South London/Manchester/Kent) Methods Participation material will be co-developed with local PPI for participants, community leaders and partners. Adaptations required for different under-served communities will be evaluated. Postpartum health champions will be recruited through local and midwifery networks. Women with hypertensive disorders of pregnancy or gestational diabetes (N=162) will be approached (antenatally/postnatally) and asked to recruit a 'study-buddy'. After completing breast-feeding, women and their 'study-buddy' will be randomised to SGLT2i for 3 or 6-months or standard care (1:1:1). Home lab testing kits ± SGLT2i will be posted to their home, and safety and outcome data (BP, weight, capillary blood, urine, endothelial health) will be collected remotely for 12-months. Recruitment rates, adherence, data completeness, clinical outcome parameters, factors influencing engagement (postpartum health champion/study-buddies, provision of tablets, digital support) and women, 'study-buddies' and postpartum health champions' experience will be evaluated. Timelines Months 1-12: Material co-development, study set-up, postpartum health champion recruitment Months 13-48: Recruitment, remote data collection Months 49-60: Women/Study-buddy/champion experience assessment, data analysis, dissemination Anticipated impact/dissemination Participants will be sent regular text message/WhatsApp/email/letters about progress (e.g. recruitment). After completion, findings developed with PPI will be presented at virtual or face-to-face meetings and communicated to all participants. Academic outputs will be disseminated through peer-reviewed journals, international conferences and through social media to primary and secondary care. Feasibility study findings will be used to support funding applications for trials of complex interventions with enhanced recruitment in under-served communities with the following end points: - onset of hypertension and/or type 2 diabetes in postpartum women with hypertensive disorders of pregnancy or gestational diabetes people with 'pre-diabetes/pre-hypertension' (from 'study-buddy' data) - maternal and neonatal complications in women with pre-pregnancy CVD risk factors Reducing modifiable cardiovascular risk factors in under-served communities could substantially improve health equity for the most severely affected groups.
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