FRAME: Federated Research on Anti-hypertensives Maternity Emulation Trial

Hypertension complicates approximately 10–15% of pregnancies and significantly increases risks for both mothers and babies. While antihypertensive medications are widely used, there is limited evidence on whether treatment effects vary across different ethnic groups or how exposure may influence long-term child development.

FRAME will use observational healthcare data to emulate randomised clinical trials through a federated analysis approach. By analysing comparable populations across multiple Trusted Research Environments while keeping data within secure settings, the project will evaluate treatment outcomes across diverse groups.

The work will also develop methodological guidance for conducting federated trial emulation, contributing to emerging national approaches to observational causal inference using secure health data.

Public involvement and engagement are central to the project. The SAIL Consumer Panel will provide advice throughout the research process, ensuring that the work reflects public priorities and expectations. Findings will be shared through accessible summaries, collaboration with pregnancy charities, and engagement with clinical and policy communities.

By the end of the project, FRAME will:

• Develop methodological recommendations for federated trial emulation in pregnancy research
• Investigate whether antihypertensive treatment effects vary by ethnicity
• Assess potential long-term developmental outcomes for children exposed to treatments in utero
• Produce peer-reviewed publications and conference presentations
• Deliver accessible public-facing materials explaining the research findings

Project information

Lead organisation: Swansea University
Principal investigator: Sinead Brophy
Project duration: 12 months
Project partners: Secure eResearch Platform (SeRP), CPRD (Clinical Practice Research Datalink), King’s College Hospital NHS Foundation Trust, Guys and St Thomas NHS Foundation Trust, University of Edinburgh, University of Birmingham, and SAIL Databank
Funding provided: £446,795
Primary contact email: s.brophy@swansea.ac.uk