The PreEclampsia Postpartum Prevention Trial

NCT ID: NCT07199283

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-05-31

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)

Detailed Description

PURPOSE AND AIMS:

The overall aim of this 9-month multicentre, two-arm, single-blind, parallel-group RCT across several regions in Sweden is to improve cardiometabolic health in women after a first pregnancy complicated by preeclampsia, through a bundle intervention of combined evidence-based components delivered primarily via a trial-specific mobile health (mHealth) app.

The primary aim of the 9-months PEPP (PreEclampsia Postpartum Prevention) randomized controlled trial (RCT) is to evaluate if a bundle intervention is more effective than standard postpartum care in reducing systolic and diastolic blood pressure levels among first-time mothers with a recent diagnosis of preeclampsia.

Secondary aims are to evaluate whether the bundle intervention, compared to standard care, leads to greater postpartum weight loss (i.e. reduction of pregnancy-related weight gain), and greater reduction in blood pressure and weight when stratified by early pregnancy body mass index (BMI) <25/≥25 kg/m2.

Exploratory aims are to evaluate if the intervention improves the identification of additional CVD risk factors, enhances patient CVD awareness, increases physical activity, promotes a healthier diet, and improves wellbeing.

As the intervention evaluated in the trial consists of a bundle intervention including multiple interacting components, a process evaluation will be undertaken in parallel.

The investigators hypothesize that the bundle intervention will effectively reduce systolic and diastolic blood pressure and improve additional cardiometabolic and lifestyle-related factors. These factors are closely linked to the risk of future pregnancy complications and the development of vascular dysfunction.

STUDY DESIGN:

Population:

The investigators will recruit 760 first-time mothers in the early postpartum period with a preeclampsia diagnosis in their medical records, validated by research personnel. Women agreeing to participate in the trial will be invited to an in-person baseline visit (at home or in hospital) for baseline measurements and data collection. Participants will then be randomized in a 1:1 ratio to either the bundle intervention in addition to standard care, or standard care alone for the 9-month trial. Follow-up measurements and data collection will be conducted at 3 and 9 months for all participants.

Intervention:

A 9-month bundle intervention, consisting of evidence-based components aimed at enhancing cardiometabolic health, including targeted screening, self-monitoring, lifestyle modification, health education, motivational information, and support delivered via the trial-specific PEPP app (available for the intervention group only) and from health care study personnel. The PEPP-app's content partly builds on apps previously developed by our team members, focusing on physical activity, healthy dietary habits, and the integration of various behavior change techniques. It has been refined based on results from our feasibility study and patient representatives' input. The intervention starts with a Light phase and is followed by a more Intensive phase.

• Light phase (baseline-3 months): After randomization, the Light phase begins with an online visit with study healthcare personnel, for feedback from baseline measurements (e.g. targeted screening including blood pressure, blood glucose and blood lipids) as well as health education (e.g. preeclampsia and cardiovascular health). The app is then used for self-monitoring of blood pressure via a validated cellular-connected device, lifestyle modification (individual step count goals), health education (articles and podcasts), and support through chat and e-mail with study personnel. An online behavior modification group meeting with participants and study personnel will be held at about 1-2 months.
• Intensive phase (3-9 months): In addition to the features of the Light phase this phase includes an online visit with study healthcare personnel to provide feedback on 3-months screening results (targeted screening). It also introduces expanded features in the app on lifestyle modifications (individual goals for moderate-to-vigorous physical activity, a healthy-heart eating program to improve dietary quality), expanded health education, and additional self-monitoring of weight through a validated cellular-connected device. Online group meetings will be held during the intensive phase.

Control:

Standard care: Participants in the control group will receive standard postpartum care, in accordance with current clinical practices. According to Swedish guidelines. The control group will attend the trial visits for measurements at baseline and at 3 and 9-months follow-up.

Conditions

Preeclampsia; Postpartum Period; Hypertension; Cardiovascular Diseases; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Standard Care

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bundle Intervention

Bundle Intervention

Group Type: EXPERIMENTAL

Bundle Intervention

Intervention Type: OTHER

Bundle intervention

Interventions

Bundle Intervention

Bundle intervention

Intervention Type: OTHER

Eligibility 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, Arabic, Somali, Dari, Persian, or Spanish
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Kari Johansson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Sandstrom, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Kari Johansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, Stockholm County, Sweden

Countries

Sweden

Central Contacts

Kari Johansson, PhD

Role: CONTACT

kari.johansson@ki.se

+46706954926

Anna Sandström, PhD, MD

Role: CONTACT

anna.sandstrom@ki.se

Facility Contacts

Kari Johansson Haga

Role: primary

kari.johansson@ki.se

+46706954926

Other Identifiers

2024-03584-01

Identifier Type: -

Identifier Source: org_study_id