Postpartum program to prevent cardiometabolic problems after preeclampsia
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
This study will test a 9-month app-based support program to lower blood pressure and help with weight loss in first-time mothers who recently had preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm, Stockholm County and 1 other locations) |
| Trial ID | NCT07199283 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, two-arm, single-blind randomized trial enrolling first-time mothers 6–11 weeks after a singleton birth complicated by preeclampsia. Participants are randomized to a 9-month bundled intervention delivered mainly via a trial-specific mobile health app (including targeted screening, group meetings, and self-monitoring tools for blood pressure and weight) or to standard postpartum care. Clinical visits at Karolinska sites are used for outcome assessments, with primary outcomes of systolic and diastolic blood pressure and secondary outcomes including postpartum weight change. A concurrent process evaluation will examine how the multiple components interact and influence cardiometabolic and lifestyle-related outcomes.
Who should consider this trial
Good fit: First-time mothers aged 18 or older with a recent first-pregnancy diagnosis of preeclampsia, a live singleton infant, ability to consent, Swedish or English language skills, and an Android or iOS smartphone are ideal candidates.
Not a fit: Women with pre-existing hypertension, diabetes, cardiovascular or kidney disease, certain autoimmune conditions, active eating disorders, or who are currently pregnant are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could lower postpartum blood pressure and support sustained weight loss, reducing future cardiovascular risk for affected women.
How similar studies have performed: Elements such as mHealth support, self-monitoring of blood pressure and weight, and lifestyle counseling have shown modest benefits in postpartum or cardiometabolic settings, but bundling these components specifically for post-preeclampsia care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Stockholm County and 1 other locations
- Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Recruiting)
- Karolinska Institutet — Stockholm, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Anna Sandstrom, PhD, MD — Karolinska Institutet
- Study coordinator: Kari Johansson, PhD
- Email: kari.johansson@ki.se
- Phone: +46851776278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.