PreeclampsiaPEPPNCT07199283
The PreEclampsia Postpartum Prevention Trial
A study testing Bundle Intervention in people with Preeclampsia and Postpartum Period, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Postpartum Period, Hypertension
- What is being tested?
- Bundle Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Sandström, PhD, MD contact
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 17176
Anna Sandström, PhD, Associate Professor, +46851776278, anna.sandstrom@ki.se
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 17177
Kari Johansson Haga, +46706954926, kari.johansson@ki.se
About this study
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
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.
Read more
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)
Read the detailed description
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.
- Light phase (baseline-3 months): After randomization (6-11 weeks postpartum), 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
- Being tested
- Bundle Intervention
- Keywords
- Preeclampsia, Postpartum prevention, Prevention cardiometabolic disease, Hypertension, Postpartum weight loss
- Medical subject headings
- Pre-Eclampsia, Hypertension, Cardiovascular Diseases, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundle InterventionOther
Bundle intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard care |
| Bundle Intervention | Experimental | Bundle Intervention Receives: Other: Bundle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic (sBP) blood pressure (mmHg)
Change in systolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.
Measured: 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.
Measured: From baseline to end of study at 9 months follow-up
Secondary outcomes (1)
Change in postpartum weight (kilograms, kg)
Change in postpartum body weight (kg), measured using a validated scale
Measured: From baseline to end of study at 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Johansson, Karolinska Institutet
- Investigators
- Anna Sandstrom, PhD, MD, Principal investigator, Karolinska InstitutetKari Johansson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199283
- Sponsor's protocol ID
- 2024-03584-01
- Acronym
- PEPP
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07199283
- Acronym / sponsor ID
- PEPP / 2024-03584-01
- Conditions
- Preeclampsia, Postpartum Period, Hypertension, Cardiovascular Diseases, Overweight, Obesity
- Keywords
- Preeclampsia, Postpartum prevention, Prevention cardiometabolic disease, Hypertension, Postpartum weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
- Light phase (baseline-3 months): After randomization (6-11 weeks postpartum), 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard care |
| Bundle Intervention | Experimental | Other: Bundle InterventionBundle Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First-time mothers postpartum
- Preeclampsia during first pregnancy
- Age ≥ 18 years
- Singleton live birth (infant still alive)
- Ability to understand and speak Swedish, English
Key exclusion criteria (8 listed)
- Pre-pregnancy hypertension
- Diabetes mellitus type I or II
- Cardiovascular disease
- Kidney disease
- Systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundle InterventionBundle intervention | Other | Bundle Intervention |
Primary outcome
Change in systolic (sBP) blood pressure (mmHg)
Time frame: From baseline to end of study at 9 months follow-up
Change in systolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.
Change in diastolic blood pressure (mmHg)
Time frame: From baseline to end of study at 9 months follow-up
Change in diastolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.
1 secondary outcome
Change in postpartum weight (kilograms, kg)
Time frame: From baseline to end of study at 9 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Sandström, PhD, MD contact
Anna Sandstrom, PhD, MD principal investigator
Karolinska Institutet
Kari Johansson, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle Intervention in people with Preeclampsia and Postpartum Period, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kari Johansson, PhD (+46851776278, kari.johansson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic (sBP) blood pressure (mmHg) (time frame: From baseline to end of study at 9 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.