An interventional study of Access to MumCare app in Hypertensive Disorder of Pregnancy, Preeclampsia and Gestational Hypertension, sponsored by Oslo University Hospital. Enrolling by invitation at 1 site in Norway. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Supportive care
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:
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).
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 400 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids
General Practitioner attendance 1 year postpartum
Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)
Time frame: 1 year 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 14-18 months postpartum
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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