Clinical trial

The PreEclampsia Postpartum Prevention Trial

Recruiting now · Not applicable · 1 countries · Registry ID NCT07199283

Recruiting nowNot applicableInterventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionPreeclampsia, Postpartum Period, Hypertension, Cardiovascular Diseases, Overweight, Obesity

Full registry criteria

Inclusion Criteria * 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 Criteria: * 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

Treatments and study arms

Bundle Intervention

Other

Bundle intervention

Primary outcomes

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

Change in systolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.

Change in diastolic blood pressure (mmHg)From baseline to end of study at 9 months follow-up

Change in diastolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Karolinska Institutet🇸🇪 Stockholm, Stockholm County, Sweden

Open map

Kari Johansson HagaContact

Email · Call +46706954926

Karolinska University Hospital🇸🇪 Stockholm, Stockholm County, Sweden

Open map

Anna Sandström, PhD, Associate ProfessorContact

Email · Call +46851776278