MumCare: Mum's Cardiovascular Health for Life

Enrolling by invitation · Not applicable

Conditions studied: Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension, Gestational Diabetes

In brief

The goal of this randomized clinical trial study is to test the potential benefits of eHealth-assisted follow-up after pregnancy complications that confer and increased risk for premature cardiovascular (CV) disease. The overarching aim is to improve short- and long-term CV health in women following pregnancy complications associated with increased risk of CV disease (hypertensive disorders of pregnancy and gestational diabetes). The investigators will develop and test a novel, personalized and user co-designed digital eHealth companion ("app") and test the app in a clinical randomized control trial. The group randomized to app use will get access to the app prior to delivery or within the first weeks postpartum, whereas the control group will not get access to the app, but receive ordinary follow-up. Both groups are invited to a comprehensive cardiovascular follow-up 14-18 months post delivery. The primary objective is to assess whether the rate of 1-year postpartum follow-up at the general practitioner's is increased with MumCare app access. Secondary objectives are to assess: 1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies, 2. if health perception, sense of empowerment (self-management evaluation and general self-efficacy), modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight, physical activity), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Key facts

Study ID: NCT05835596
Run by: Oslo University Hospital
People needed: 400
Starts: 2024-06-18
Expected to finish: 2029-09-01
Last updated by the study team: 2026-02-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

An ongoing or recent pregnancy complicated by hypertensive disorder of pregnancy and/or gestational diabetes mellitus
Patient attending Oslo University Hospital, Oslo, Norway
Signed informed written consent (to be randomized to app access or not)

You may not qualify if…

Prepregnancy diagnosis of hypertension and/or diabetes mellitus (type I/II) (as these groups likely receive adequate cardiovascular follow-up )
Prepregnancy diagnosis of kidney or cardiovascular disease (as these groups likely receive adequate cardiovascular follow-up )
Not capable of accessing and using an app downloaded on a smart phone
Not able to understand the informed consent or app instructions or content (The patient information/informed study consent is available in in Norwegian and English, as is the MumCare app. The patient can herself chose either language in the appp, and easily convert from the Norwegian to the English version (and vice versa), without losing registered health data).

Where it is running

Oslo University Hospital — Oslo, Oslo, Norway

Full record on ClinicalTrials.gov

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