MumCare: Mum's Cardiovascular Health for Life

Summary

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.

Conditions

• Hypertensive Disorder of Pregnancy
• Preeclampsia
• Gestational Hypertension
• Gestational Diabetes

Interventions

DEVICE

Access to MumCare app

Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids

Sponsors & Collaborators

• Norwegian SIDS and Stillbirth Society

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Anne Cathrine Staff, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-18

Primary Completion

2029-09-30

Completion

2029-09-30

Countries

• Norway

Study Locations