MumCare: Mum's Cardiovascular Health for Life (MumCare)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preeclampsia; Gestational Diabetes; Hypertensive Disorder of Pregnancy; Gestational Hypertension
• Intervention / Treatment: Device: Access to MumCare app

Detailed 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 objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers).

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo County
    • Oslo, Oslo County, Norway, 0424
      • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Access to MumCare app; 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; Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids
No Intervention: No access to MumCare app; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cardiovascular follow-up at recruitment hospital: Blood pressure	Normotension (or not) at 14-18 months postpartum (blood pressure below 140 mmHg systolic AND below 90 mmHg diastolic)	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: BMI	Normal weight (or not) at 14-18 months postpartum; defined as body mass index (weight in kilo s divided by height in square meters) below 25 kg/m2	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: HbA1c	Normal HbA1(or not) at 14-18 months postpartum; defined as below 42 mmol/L. Diabetes mellitus is diagnosed if HbA1c is 48 mmol/L or above, whereas HbA1c of 42-47 mmol/L indicates high risk for developing diabetes (and life style intervention combined with annual HbA1c assessment is therefore recommended)	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: HDL	Normal (or not) level of high density lipoprotein at 14-18 months postpartum; defined as HDL of 1.3 mmol/L or above (for women). HDL below 1.3 mmol/L indicates high risk for developing cardiovascular disease.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol	Normal (or not) level of total serum cholesterol at 14-18 months postpartum; defined as serum cholesterol at or below 5 mmol/L. Total cholesterol above 5 mmol/L indicates increased risk for developing cardiovascular disease. Total cholesterol of or above 7 mmol/L indicates most often therapy.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol	Normal (or not) level of LDL (low density lipoprotein) cholesterol at 14-18 months postpartum; defined as LDL cholesterol at or below 3 mmol/L. LDL cholesterol above 3 mmol/L indicates increased risk for developing cardiovascular disease. LDL cholesterol of or above 5 mmol/L indicates most often therapy.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: fTG	Normal (or not) level of fasting serum triglycerides at 14-18 months postpartum; defined as fTG at or below 1.7 mmol/L. fTG above 1.7 mmol/L combined with HDL cholesterol below 1.2 mmol/L in women indicates dyslipidemia and increased risk for developing cardiovascular disease.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: ApoB	Normal (or not) serum Apolipoptotein B at 14-18 months postpartum; defined as ApoB above 1.4 g/L. The normal reference range for women is 0.5-1.4 g/L. High levels indicate increased risk for developing cardiovascular disease.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: Apo A1	Normal (or not) serum Apolipoptotein A1 at 14-18 months postpartum; defined as Apo A1 within the normal reference range for women: 1.1-2.0 g/L.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: ApoB/Apo A1 ratio	Normal (or not) serum Apolipoptotein B/Apolipoprotein A1 ratio at 14-18 months postpartum; defined as ApoB/Apo A1 ratio at or below 0.6. In women, a ratio above 0.6 indicates increased risk of cardiovascular disease.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: waist-hip-ratio	Normal (or not) waist to hip ratio (both measured in same unit; in nearest full cm) at 14-18 months postpartum; defined as a ratio below 0.85 in women.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: waist circumference	Normal (or not) waist circumference (measured in nearest full cm) at 14-18 months postpartum; defined as a below 88 cm in women.	14-18 months postpartum
Clinical cardiovascular follow-up at recruitment hospital: serum biomarkers associated to cardiovascular risk	Compare serum cardiovascular biomarker levels (between the 2 study groups) at a general cardiovascular health assessment at 14-18 months postpartum. Following (elevated levels) biomarkers have been associated with increased cardiovascular risk, and will be assessed for group comparison following study finalization: hsCRP, high-sensitive C-reactive protein GDF-15, growth differentiation factor 15 sHLA-G, soluble human leukocyte antigen G cTnT, cardiac-specific high sensitive Troponin T NT-proBNP, n-terminal pro-brain natriuretic peptide SAA1, serum amyloid 1	14-18 months postpartum
Patient Reported Outcome Measures (PROM); heiQ	Patient reported (by online questionnaires) health-related quality of life: health education impact questionnaire. The Health Education Impact Questionnaire (heiQ) scale consists of 40 items representing 8 domains that evaluates immediate effects of self-management interventions. Items are scored on a scale ranging from 1 (strongly disagree) to 4 (strongly agree), higher score in the heiQ scales indicates better status, except for "emotional distress", where higher score indicates higher distress.	12-14 months postpartum
Patient Reported Outcome Measures (PROM); GSE	Patient reported (by online questionnaires) health-related quality of life: general self-efficacy scale. The General Self Efficacy (GSE) Scale measures optimistic self-beliefs in coping with the challenges of life. : "refers to optimistic self-beliefs of being able to perform and control behaviors, and is linked with various physical and mental health outcomes". Responses on 10 items are reported on a four point scale ranging from 1 (not at all true) to 4 (exactly true). The score of the total scale ranges from 10 to 40, higher score indicates higher GSE.	12-14 months postpartum
Patient Reported Outcome Measures (PROM); IPAQ	Patient reported (by online questionnaires) physical activity The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. The "last 7 days recall" short form of IPAQ is used in the MumCare study to assess level of physical activity. The short version (9 items) asks for information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity. Participants are instructed to refer to all domains of physical activity.	12-14 months postpartum
System usability scale (SUS) questionnaire	Patient reported (for the group randomized to MumCare app access) (by online questionnaire) usability of the Mumcare health app, by the most frequently used questionnaire today to assess eHealth applications (SUS).	12-14 months postpartum
Qualitative interviews of users and their General Practiotioner	Compare user experiences (health perception, empowerment, quality of life) with and without app use (for both woman and her GP)	14-18 montths postpartum

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Norwegian SIDS and Stillbirth Society
• Investigators: Principal Investigator: Anne Cathrine Staff, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Infections; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension; Nutritional and Metabolic Diseases; Diabetes, Gestational; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Toxemia
• Other Study ID Numbers: 478376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only data that alone or in combination cannot identify a unque patient will be shared, that is at group level, in accordance with patient consent and IRB approval in Norway.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No