COMPASS

Hypertensive disorders of pregnancy (HDP) affect around 10% of pregnancies and carry substantial maternal morbidity and elevated long-term cardiovascular risk. The early postpartum period is a critical but under-monitored window for cardiovascular intervention. COMPASS evaluates wearable blood pressure (BP) monitoring using the Huawei D2 smartwatch, integrated with the RADAR-base platform and a digital assistant, combined with clinician-guided antihypertensive titration, in postpartum women with HDP or new-onset postnatal hypertension. Deep phenotype data will be extracted from a combination of structured and unstructured (free text) data from the Electronic Health Record (EHR) leveraging CogStack technology, to support comprehensive clinical outcomes and cost effectiveness analysis. The study assesses feasibility, acceptability, clinical effectiveness and cost-effectiveness of this novel postpartum pathway, and generates preliminary data and personalised cardiovascular risk prediction models to inform a future definitive trial. The intervention period extends to 6 months postpartum.

Objectives

1. Evaluate the feasibility, acceptability and implementation of remote postpartum BP monitoring, including a digital cardiovascular platform and wearable monitoring with the Huawei D2 smartwatch, in women with HDP or new-onset postnatal hypertension.
2. Assess the acceptability, adherence and feasibility of wearable BP monitoring.
3. Evaluate clinical outcomes including hospital readmissions and hypertensive or hypotensive crises.
4. Assess patient-reported outcomes including quality of life and anxiety.
5. Determine the cost-effectiveness of the intervention.
6. Develop personalised cardiovascular risk prediction models using longitudinal BP data.

Study design

Prospective, multicentre, open-label, pilot three-arm parallel-group randomised controlled trial. 120 postpartum women aged 18 or over with HDP or elevated postpartum BP requiring clinical monitoring, randomised 1:1:1 (n=40 per arm). Pregnant or within 10 days postpartum at enrolment, and currently prescribed antihypertensive medication.

Arm 1: Standard of care (routine postpartum hypertension management per local and national guidelines).

Arm 2: Remote monitoring and self-management with a validated brachial BP monitor and digital cardiovascular platform, clinician-supported antihypertensive titration, and an extended six-week discharge prescription.

Arm 3: All Arm 2 components plus a Huawei D2 smartwatch for wearable BP monitoring, integrated into the RADAR-base platform.

Intervention period 0 to 6 months postpartum. Analysis focuses on feasibility outcomes (recruitment, retention, adherence, engagement, data completeness), with preliminary effect-size estimates to inform a future definitive trial.