Postpartum program to prevent cardiometabolic problems after preeclampsia
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
Run by Karolinska Institutet · NCT07199283 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 356 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm, Stockholm County and 1 other locations) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07199283 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.