A mobile health-assisted cardiovascular follow-up after pregnancy complications (MumCare): protocol for a randomized controlled trial

Objective A history of hypertensive disorders of pregnancy and/or gestational diabetes is associated with increased risk of long-term maternal cardiovascular (CV) disease. Despite recommendations for preventive strategies, few women receive CV follow-up postpartum. We have developed a personalized digital mobile Health companion, the MumCare (Mum’s cardiovascular health for life) application, aiming at improving control of modifiable risk factors for CV disease and to bridge hospital and community health services. This paper describes the protocol for a MumCare randomized controlled trial in Norway. Methods Study participation is offered to women at Oslo University Hospital with a diagnosis of hypertensive disorders of pregnancy and/or gestational diabetes. Following informed consent (either during pregnancy or within 4 weeks postpartum), a block randomization process assigns participants to one of two groups (access to the Mum Care app or not). The app provides educational material, allows women to track modifiable risk factors, and prompts feedback to registered blood pressures. It also prompts the women to book the nationally recommended follow-up at their general practitioner’s at 3–4 and 12 months postpartum. The primary study objective is to assess the effect of MumCare application access on 1-year follow-up rate with a general practitioner. Secondary objectives are to assess group differences at 14 months postpartum regarding: 1) satisfaction with the postpartum mHealth-assisted technology, 2) self-management evaluation, general self-efficacy; and at 14–18 months: 3) modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight and physical activity), CV non-invasive hemodynamics and CV-related biomarkers. Discussion This randomized controlled trial tests the effect of a mobile Health-assisted follow-up of modifiable risk factors after pregnancy complications associated with premature CV disease in women. A study limitation is a risk of underrepresentation of recently immigrated women due to the restricted language options offered in the app. Study protocols registration NCT05835596.