NCT07199283

Brief 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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Nov 2025May 2029

First Submitted

Initial submission to the registry

August 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

August 14, 2025

Last Update Submit

September 22, 2025

Conditions

PreeclampsiaPostpartum PeriodHypertensionCardiovascular DiseasesOverweightObesity

Keywords

PreeclampsiaPostpartum preventionPrevention cardiometabolic diseaseHypertensionPostpartum weight loss

Outcome Measures

Primary Outcomes (2)

  • Change in systolic (sBP) blood pressure (mmHg)

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

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

  • Change in diastolic blood pressure (mmHg)

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

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

Secondary Outcomes (3)

  • Change in postpartum weight (kilograms, kg)

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

  • Change in blood pressure (mmHg) stratified by early pregnancy BMI status

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

  • Change in postpartum weight (kilograms, kg) by early pregnancy BMI status

    From baseline to end of study at 9 months

Study Arms (2)

Standard Care

NO INTERVENTION

Standard care

Bundle Intervention

EXPERIMENTAL

Bundle Intervention

Other: Bundle Intervention

Interventions

Bundle InterventionOTHER

Bundle intervention

Bundle Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who had preeclampsia during their first pregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-time mothers postpartum
  • Preeclampsia during first pregnancy
  • Age ≥ 18 years
  • Singleton live birth (infant still alive)
  • Ability to understand and speak Swedish, English, Arabic, Somali, Dari, Persian, or Spanish
  • Having a smartphone (Android or iOS)
  • Ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Location

MeSH Terms

Conditions

Pre-EclampsiaHypertensionCardiovascular DiseasesOverweightObesity

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Sandstrom, PhD, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Kari Johansson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari Johansson, PhD

CONTACT

+46706954926kari.johansson@ki.se

Anna Sandström, PhD, MD

CONTACT

anna.sandstrom@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2025

First Posted

September 30, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

SE(1)