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The PreEclampsia Postpartum Prevention Trial

NCT07199283 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2026-05-04

No results posted yet for this study

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)

Conditions

Interventions

OTHER

Bundle Intervention

Bundle intervention

Sponsors & Collaborators

Principal Investigators

  • Anna Sandstrom, PhD, MD · Karolinska Institutet

  • Kari Johansson, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199283 on ClinicalTrials.gov