Stephanie Bonn

Preeclampsia (PE), a severe hypertensive disorder of pregnancy, is strongly associated with complications in subsequent pregnancy and early-onset cardiovascular diseases (CVD). Women with PE also have an increased risk of CVD risk factors after pregnancy, with weight retention and overweight being key modifiable factors. Thus, the postpartum phase provides a window of opportunity for implementation of screening and preventive strategies.The overall aim of this multi-centre two-armed single-blind parallel RCT is to assess the efficacy of a bundle intervention 3-12 months postpartum tailored for primiparous women with prior PE. This includes information, targeted screening and promotion of a healthy lifestyle through support by healthcare personnel and a Smartphone-App.Population: Primiparous with PE (n=724)Intervention: A bundle intervention divided into: Light intervention 3-6 months postpartum and Intensive intervention 6-12 months postpartumControl: Standard careOutcomes: Primary: weight change over 9 months. Secondary: 1) weight change over 9 months, stratified by early pregnancy BMI&lt

25/≥25

2) systolic & diastolic blood pressure 12 months postpartumThis study seeks to fill the knowledge gap of a clinically implementable postpartum intervention in women with prior PE, with specific focus on patient perspectives. Results will be used to update clinical guidelines, thereby improving short term and possibly long-term outcomes, and ultimately lower overall health costs.

Background: Preeclampsia (PE), a severe hypertensive disorder affecting about 5% of all primiparous pregnancies, is strongly associated with complications in subsequent pregnancies and early-onset of cardiovascular diseases (CVD) as myocardial infarction and stroke. Traditional CVD risk factors arising after pregnancy are strongly associated with the increased CVD risk in women with previous PE, with pregnancy weight retention and overweight/obesity being key modifiable factors. Thus, the first postpartum phase provides a window of opportunity for screening and implementing preventive interventions. Given this, there is a high clinical need for evidence-based postpartum interventions that can mitigate the risk of future overweight/obesity and to improve the cardiometabolic profile, to potentially delay or prevent future CVD. Objectives: The overall aim is to address the lack of evidence to improve cardiometabolic health in women with previous PE. With a multidisciplinary team including representatives from the PE Patient Organisation and informed by a feasibility study, we will evaluate the efficacy of a clinically implementable bundle intervention program tailored for postpartum women with PE in first pregnancy. Our hypothesis is that the intervention will be feasible with high compliance, and effective in reducing postpartum maternal BMI and improve cardiometabolic profile 1 year after birth. Work plan: We will conduct a multi-centre two-armed single-blind parallel randomised controlled trial of 700 participants (350 in each arm), between 3 to 12 months postpartum, among primiparous PE women. Participants will be allocated either a bundle intervention or standard care. The intervention includes a combination of information, targeted screening and healthy lifestyle promotion, including physical activity and a healthy diet through support by study personnel and an interactive Smartphone-App. The primary outcome will be change in BMI between baseline and follow-up. Significance: Clinically, this group of women with increased CVD-risks is often left without support. If the bundle intervention proves to be superior to standard care, implementation of the program into clinical care could improve the cardiometabolic profile of women with previous PE and potentially prevent future CVD. Furthermore, the intervention could be expanded to women with other pregnancy complications associated to CVD and parous women with PE.