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The PreEclampsia Postpartum Prevention Trial

ConditionsPreeclampsiaPostpartum PeriodHypertensionCardiovascular DiseasesOverweightObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKarolinska Institutet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

First-time mothers postpartum

Preeclampsia during first pregnancy

Age ≥ 18 years

Singleton live birth (infant still alive)

Disqualifiers

Pre-pregnancy hypertension

Diabetes mellitus type I or II

Cardiovascular disease

Kidney disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bundle Intervention

    Other intervention

    Bundle intervention

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Bundle InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in systolic (sBP) blood pressure (mmHg)

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

Time frame
From baseline to end of study at 9 months follow-up
2

Change in diastolic blood pressure (mmHg)

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

Time frame
From baseline to end of study at 9 months follow-up

Secondary outcomes

1

Change in postpartum weight (kilograms, kg)

Change in postpartum body weight (kg), measured using a validated scale

Time frame
From baseline to end of study at 9 months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov
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