The PreEclampsia Postpartum Prevention Trial

Sponsor
Karolinska Institutet
Study ID
NCT07199283
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bundle Intervention — OTHER
    Bundle intervention

Study Details

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)

Key Dates

First listed
Sep 30, 2025
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Standard Care
    Standard care
  • Experimental: Bundle Intervention
    Bundle Intervention

Primary Outcome Measure

Change in systolic (sBP) blood pressure (mmHg) [ Time Frame: From baseline to end of study at 9 months follow-up ]

Central Contacts

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