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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Karolinska Institutet
Coordinator of this site? Confirm its status
StockholmSwedenRecruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.