RecruitingNot ApplicableNCT07199283

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


Sponsor

Karolinska Institutet

Enrollment

356 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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

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Interventions

OTHERBundle Intervention

Bundle intervention


Locations(2)

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Karolinska Institutet

Stockholm, Stockholm County, Sweden

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NCT07199283


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