The PreEclampsia Postpartum Prevention Trial
Recruiting · NCT07199283 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are: * Does the 9-month intervention reduce systolic and diastolic blood pressure? * Does the intervention promote postpartum weight loss? * Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes. All participants will attend clinical visits for outcome assessments. Participants in the intervention group will: * Receive online targeted screening and group meetings with study personnel * Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education * Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)
Who can take part
Inclusion criteria
- First-time mothers postpartum
- Preeclampsia during first pregnancy
- Age ≥ 18 years
- Singleton live birth (infant still alive)
- Ability to understand and speak Swedish, English
- Having a smartphone (Android or iOS)
- Ability to provide informed consent
Exclusion criteria
- Pre-pregnancy hypertension
- Diabetes mellitus type I or II
- Cardiovascular disease
- Kidney disease
- Systemic lupus erythematosus
- Antiphospholipid syndrome
- Previous or current eating disorders
- Ongoing new pregnancy
Where it is running
2 locations listed.
- Karolinska University Hospital - Stockholm, Stockholm County, Sweden
- Karolinska Institutet - Stockholm, Stockholm County, Sweden