MumCare: Mum's Cardiovascular Health for Life

NCT05835596 | Enrolling By Invitation

• 1 other identifier: 478376
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 1.expectations of (and satisfaction with) postpartum eHealth-assisted technologies,
2. 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

Outcome Measures

Primary Outcomes (1)

• General Practitioner attendance 1 year postpartum

  Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)

  1 year postpartum

Secondary Outcomes (18)

• Patient Reported Outcome Measures (PROM); heiQ

  12-14 months postpartum

• Patient Reported Outcome Measures (PROM); GSE

  12-14 months postpartum

• Patient Reported Outcome Measures (PROM); IPAQ

  12-14 months postpartum

• System usability scale (SUS) questionnaire

  12-14 months postpartum

• Qualitative interviews of users and their General Practiotioner

  14-18 montths postpartum

Study Arms (2)

Access to MumCare app

ACTIVE COMPARATOR

Women will be randomized prospectively (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. This group is randomized to have access to the MumCare app will, in addition to standard care, have access to the app for 14-18 months following giving birth. The MumCare app has 3 main parts (1. an educational part, 2. The patient's own health data (entered by the user herself) that represent modifiable risk factors for cardiovascular disease), and 3. The app will send push reminders for the woman to book a visit at her general practitioner according to recommended guidelines (that are usually not followed-up today). All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.

Device: Access to MumCare app

No access to MumCare app

NO INTERVENTION

Women will be prosepctively randomized (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. Women randomized to NOT have access to the MumCare app will receive standard care, which includes being provided oral and written information according to delivery ward routines. All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.

Interventions

Access to MumCare app DEVICE

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

Access to MumCare app

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian SIDS and Stillbirth Society: collaborator
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anne Cathrine Staff, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of research (Div. Obst and Gyn)

Model Details: Women are ranomized to MumCare app access or not for the 14-18 month intervention time

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 28, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)