MumCare: Mum's Cardiovascular Health for Life — MumCare  

Gestational Diabetes Clinical Trial

Official title: MumCare: Mum's Cardiovascular Health for Life

Status Enrolling by invitation

Clinical Trial 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, quality of life, modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Clinical Trial Description

Cardiovascular disease (CVD) is a leading cause of premature death and morbidity in women. CVD prevention is most effective when started at subclinical stages. Preeclampsia, gestational hypertension, and gestational diabetes are female sex-specific risk factors for CVD. Postpartum follow-up programs for the primary prevention of CVD following these complications are not offered today. In the MumCare study, a randomized control trial (RCT) will test a new eHealth app that promotes a personalized cardiovascular (CV) health optimization in young women after such pregnancy complications.

The study will first assess users' expectations of eHealth-assisted follow-up following the aforementioned pregnancy complications. These users will test and help fine-tune the new MumCare app, which integrates patient self-registered health data with an educational follow-up program based on Norwegian obstetric - and the Norwegian Directorate of Health guidelines. The study will recruit women to use the MumCare app in a 1:1 RCT lasting 18 months postpartum. App use (in the active study arm) will be registered in secure IT systems.

The primary outcome for comparison between groups (women with and without app access) is the rate of 1-year postpartum follow-up with a general practitioner (as recommended in the obstetric guidelines). Secondary outcomes include user-reported outcomes (such as health empowerment and quality of life) and objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers). ;

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Preeclampsia
• Toxemia

• NCT number: NCT05835596
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 18, 2024
• Completion date: September 2029