About this trial
In this project, the investigators aim to study how all these factors determine the cardiovascular status of a total of 1,800 mothers, 3 to 6 years after delivery. In addition, the investigators want to assess whether lifestyle and living conditions after childbirth may improve or worsen this imprint, since women often prioritize their families over themselves, making it more difficult to maintain a healthy lifestyle that could reduce their cardiovascular risk. Furthermore, the investigators will evaluate how environmental exposures influence their health, as well as explore potential strategies for prediction and prevention.
The goal is to develop an easy-to-use algorithm or test that allows women and their physicians to assess this risk, ideally in the form of a mobile app. Although predictive algorithms for cardiovascular health already exist, most have been developed using predominantly male or older populations, and none have taken into account pregnancy-related events or environmental exposure - both of which are key determinants of women's cardiovascular health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients who participated in the BiSC (Barcelona Life Study Cohort), EuroPE (Randomized open-label control trial to evaluate if the incorporation of sFlt1/PlGF ratio in the diagnosis and classification of PE improves maternal and perinatal outcomes in women with suspicion of the disease; PI16/00375) and AngioCor (Cardiac dysfunction and remodeling in patients with preeclampsia regulated by antiangiogenic environment: clinical and experimental approach, PI19/00702) cohort studies
Who have delivered within the previous 3-6 years.
Give written consent when invited to participate in this study protocol.
Disqualifiers
Unwillingness to participate in this study
Probability of loss to follow-up.
Trial population
Young women who presented an index pregnancy with and without placental complications, who have previously participated in cohort studies performed by our group identifying biophysical, biochemical, psychosocial and environmental cardiovascular risk factors during pregnancy
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Hypertension
Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg)
Abnormal cardiac function
Abnormal cardiac function in the echocardiographic ultrasound assessment. Abnormal values of the different parameters will be considered according to reference limits published in 2020 by the British Society of Echocardiography
Biochemical cardiac markers
Abnormal biochemical cardiac markers: NTproBNP \>300 ng/L or high-sensitivity troponin\>30 ng/L
Coronary artery disease
Signs of coronary artery disease by computer tomography (CCT) myocardial perfusion imaging (mild (CACS≥10 AU and \<100 AU); moderate (CACS≥100 AU and \<400 AU) and severe (CACS ≥400 AU)
Secondary outcomes
Age
Patient age
Pregnancy complications
Preeclampsia, pregnancy complications, presence of fetal distress, perinatal mortality, neonatal morbidity, and neonatal mortality.
Antrophometric measurements
Percentages of body fat, muscle mass, visceral fat
Blood pressure
Systolic and Dyastolic blood pressure
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Hospital Sant Joan de Deu
Collaborator
Barcelona Institute for Global Health
Collaborator