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NOT YET RECRUITING
NCT07199283
NA

The PreEclampsia Postpartum Prevention Trial

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

760

Start Date

2025-11

Completion Date

2029-05

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

OTHER

Bundle Intervention

Bundle intervention

Locations (1)

Karolinska Institutet

Stockholm, Stockholm County, Sweden