An interventional study of Bundle Intervention in Preeclampsia, Postpartum Period and Hypertension, sponsored by Karolinska Institutet. Recruiting at 2 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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:
All participants will attend clinical visits for outcome assessments.
Participants in the intervention group will:
PURPOSE AND AIMS:
The overall aim of this 9-month multicentre, two-arm, single-blind, parallel-group RCT starting 6-11 weeks postpartum 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).
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 356 first-time mothers in the early postpartum period (6-11 weeks) 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.
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 356 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care
Bundle Intervention
Other: Bundle Intervention
Bundle intervention
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
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
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
Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is close to that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.