Hypertensive Disorder of PregnancyMumCareNCT05835596
MumCare: Mum's Cardiovascular Health for Life
A study testing Access to MumCare app in people with Hypertensive Disorder of Pregnancy and Preeclampsia, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension
- What is being tested?
- Access to MumCare app
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- 18 Jun 2024to Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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:
- expectations of (and satisfaction with) postpartum eHealth-assisted technologies,
- 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.
Read the 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).
- Conditions
- Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension, Gestational Diabetes
- Being tested
- Access to MumCare app
- Medical subject headings
- Toxemia, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to MumCare appDevice
Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Practitioner attendance 1 year postpartum
Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)
Measured: 1 year postpartum
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 14-18 montths postpartum
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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 14-18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start18 Jun 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Women are ranomized to MumCare app access or not for the 14-18 month intervention time
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian SIDS and Stillbirth Society, University of Oslo
- Responsible party
- Principal investigator, Anne Cathrine Staff, Oslo University Hospital
- Investigators
- Anne Cathrine Staff, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835596
- Sponsor's protocol ID
- 478376
- Acronym
- MumCare
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Staff AC, Sjaavik AD, Noll J, Sugulle M, Fiska B, Klovning A, Estensen ME, Dechend R, Waldum AH, Solbraekke KN, Aasbo G. Co-creation of a mobile health program (MumCare) for preventing maternal cardiovascular disease after pregnancy complications. Front Glob Womens Health. 2026 Apr 30;7:1717203. doi: 10.3389/fgwh.2026.1717203. eCollection 2026.
PubMed 42145904