NCT07199283Recruiting
The PreEclampsia Postpartum Prevention Trial
The PEPP Trial: A Postpartum Bundle Intervention to Improve Cardiometabolic Health in Women After a First Pregnancy Affected by Preeclampsia - a Multi-centre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 356 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 20 Apr 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Karolinska Institutet
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT07199283
What you commit to
- Study type: Interventional
- Planned participants: 356
- From 20 Apr 2026 to the primary completion date, 30 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current eating disorders
Other illness
- Pre-pregnancy hypertension
- Diabetes mellitus type I or II
- Cardiovascular disease
- Kidney disease
- Antiphospholipid syndrome
Other
- Systemic lupus erythematosus
- Ongoing new pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.