An observational study in Cardiovascular (CV) Risk, Preeclampsia (PE) and Fetal Weight, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
Cardiovascular diseases (CVD) are the leading cause of death among women, particularly non-obstructive myocardial infarction, heart failure, and stroke. However, neither women themselves nor, often, their physicians are fully aware of this reality. This lack of awareness is partly due to gender-related myths and biases that have led to insufficient study of the specific causes and risk factors that affect women's cardiovascular systems. Traditionally, it has been assumed that cardiovascular risk mechanisms, prediction, diagnosis, and treatment are the same in men and women. Today, it is known that this is not true: while the severity and mortality due to cardiovascular disease have decreased in men, they continue to rise and remain more severe among women.
Reproductive history and hormonal influence play a decisive role in modulating cardiovascular risk in women. Experiencing complications during pregnancy - such as preeclampsia (a hypertensive disorder caused by abnormal placental function), preterm delivery, or the birth of a low-weight infant - increases the risk of cardiovascular complications up to sevenfold later in life, compared with women who had normal pregnancies. This is explained by the fact that the cardiovascular system undergoes major adaptive changes during pregnancy; in complicated pregnancies, these adaptations fail to occur properly, resulting in cardiovascular stress and damage.
Among the objectives of this project, the investigators also aim to evaluate other risk factors such as lifestyle and external influences like exposure to environmental pollutants, which may further contribute to cardiovascular vulnerability. Pregnancy represents a critical window of susceptibility - as seen in other conditions such as COVID-19 - during which these environmental and biological impacts on the cardiovascular system are amplified.
In this project, the aim is to investigate how all these factors determine cardiovascular health in a cohort of 1,800 mothers, assessed 3 to 6 years after childbirth. The investigators will also examine how postnatal lifestyle and self-care behaviors may either mitigate or exacerbate this imprint. Women often prioritize their families' needs over their own, which can make it difficult to maintain healthy habits that reduce cardiovascular risk. Moreover, the investigators will study how environmental exposures influence maternal health and explore potential predictive and preventive strategies.
The goal is to develop an easy-to-use algorithm or test - ideally in the form of a mobile application - to help women and their physicians assess cardiovascular risk. Although predictive algorithms for cardiovascular health already exist, they have mostly been developed in predominantly male or older populations, and none have considered pregnancy-related factors or environmental exposures, both of which are key determinants of women's cardiovascular health.
To date, preventive cardiovascular strategies have not been specifically designed for women, and even less so for recently postpartum women. Existing tools have not been adapted for this population. This project brings together obstetricians and cardiologists, as well as midwives and primary care physicians - the healthcare professionals primarily responsible for women's health and well-being. The investigators believe that this multidisciplinary approach is crucial to anticipate cardiovascular disease and implement truly preventive strategies.
All study findings will be disseminated through educational sessions for healthcare professionals, new clinical tools and practices to improve patient satisfaction, audiovisual materials for better maternal health communication, and through professional societies (such as SEGO, SEC, SEAP, SEM, etc.). Results will also be published in open-access scientific journals and shared via public outreach, including media coverage, conferences in hospitals and community centers, social media (@DonaSantPau), and the institutional website (http://www.santpau.cat/web/public/go-inici
).
The active participation of women in this study will also allow the creation of discussion and advocacy groups among participants, supporting dissemination through social media, online platforms (https://inatal.org), and patient associations (such as El parto es nuestro), as well as newspapers, radio, and television.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 1,260 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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:
CV biophysical, imaging and biochemical variables 3-6 years after index pregnancy (approximate n=1260) will be evaluated. Analyses will include urbanome, placental function and perinatal variables during index pregnancy and postnatal variables such as maternal socio-economic status, lifestyle, urban exposome, mental health, blood pressure, cardiac function, coronary artery disease by Coronary Computed Tomography (CCT) and CCT angiography, RM Quantitative Myocardial Perfusion, ophthalmic artery index, carotid intima- media thickness up to 6 years after delivery to predict higher risk for CVD later in life. Patients' needs and expectations according to CV health would be evaluated.
Hypertension
Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg)
Time frame: 3-6 years after index pregnancy
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
Time frame: 3-6 years after index pregnancy
Biochemical cardiac markers
Abnormal biochemical cardiac markers: NTproBNP \>300 ng/L or high-sensitivity troponin\>30 ng/L
Time frame: 3-6 years after index pregnancy
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)
Time frame: 3-6 years after index pregnancy
Other cardiovascular major events
Cardiovascular major events (ictus, coronary artery disease, cardiac insufficiency or myocardiopathy)
Time frame: 3-6 years after index pregnancy
Age
Patient age
Time frame: 3-6 years after index pregnancy
Pregnancy complications
Preeclampsia, pregnancy complications, presence of fetal distress, perinatal mortality, neonatal morbidity, and neonatal mortality.
Time frame: 3-6 years after index pregnancy
Antrophometric measurements
Percentages of body fat, muscle mass, visceral fat
Time frame: 3-6 years after index pregnancy
Blood pressure
Systolic and Dyastolic blood pressure
Time frame: 3-6 years after index pregnancy
Computer tomography (CCT) myocardial perfusion imaging and RM Quantitative Myocardial Perfusion
Allows an accurate and reliable assessment of both coronary epicardial stenosis and myocardial CT perfusion imaging at rest and during pharmacologic stress in the same examination. CCT will be performed with a 256-slice CT scanner (Philips Healthcare scanner) with prospective ECG-triggering as previously described. First, a noncontrast CCT will be performed to calculate the CACS using the Agatston scoring method. Second, CCTA will be performed following sublingual nitroglycerin and injection of nonionic contrast (Iopromide, Ultravist, Bayer Healthcare, Berlin, Germany). The presence of any coronary plaque (noncalcified, calcified, or mixed) and the presence of significant stenosis (≥50%) was assessed in all 17 coronary segments. One of 2 assigned and experienced cardiovascular radiologists assessed the CT scans for each participant.
Time frame: 3-6 years after index pregnancy
Cardiovascular markers in maternal blood
Venous blood samples will be collected without anticoagulant to obtain serum. Troponin T and NTproBNP will be measured in ng/ml using automated electrochemiluminescence immunoassays on the Roche Cobas platform (Roche Diagnostics GmbH, Mannheim, Germany).Intra-and interassay coefficients of variation were found to be \<5%.
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mg/dl
glucose, uric acid, creatinine, VLDL, LDL, HDL, total cholesterol, triglycerides
Time frame: 3-6 years after index pregnancy
Cardiovascular assessment according to IBERLIFERISK score
A score \>50% is considered as a high-risk for CVD.
Time frame: 3-6 years after index pregnancy
Hair sampling for cortisol determination
Hair samples will be cut with scissors from the region of the posterior vertex, as close to the scalp as possible. Considering that hair grows approximately 1 cm per month, 3 cm will be obtained in order to evaluate hair cortisol levels representative of the last 3 months. Samples will be stored (in a dark container at room temperature) until analysis by liquid chromatography mass spectrometry.
Time frame: 3-6 years after index pregnancy
Diet and nutrition
evaluated by means of the Short Diet Quality Screener by REGICOR (registre Gironí del Cor) and by means of the validated 14-item questionnaire of adherence to the Mediterranean diet. Escale from 1-31. The highest the score, the highest the adherence to the mediterranean diet.
Time frame: 3-6 years after index pregnancy
Physical activity
evaluated by means of the Physical Activity Questionnaire by REGICOR, a validated questionnaire for quantifying physical activity in our population. The short questionnaire estimates energy expenditure in total PA and by intensity (light, moderate, vigorous), and includes 2 questions about sedentary behavior and a question about occupational PA.
Time frame: 3-6 years after index pregnancy
Stress
evaluated by the Perceived Stress Scale (PSS) Questionnaire, validated for quantifying perceived stress in our population. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived this: Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Time frame: 3-6 years after index pregnancy
Mental health
evaluated by the Psychiatric Diagnostic Screening Questionnaire (PDSQ), a brief, psychometrically strong, self-report scale designed to screen for the most common disorders encountered in outpatient mental health settings and validated in our population. The final version of the questionnaire contains 13 subscales (major depressive disorder \[MDD\], bulimia, post-traumatic stress disorder \[PTSD\], panic disorder, agoraphobia, social phobia, generalized anxiety disorder \[GAD\], obsessive-compulsive disorder \[OCD\], alcohol abuse/dependence, drug abuse/dependence, somatization, hypochondriasis, and psychosis). Additionally, there is a six-item psychosis screen.
Time frame: 3-6 years after index pregnancy
Smoking habit
evaluated by the Fagerström Questionnaire, validated questionnaire for quantifying dependence on smoking in our population.
Time frame: 3-6 years after index pregnancy
Women experiences and eHealth
For this aim, a team of anthropologists with a long experience in the fields of health and reproduction will use qualitative methods to understand the needs of women with and without CV risk after pregnancy. To this end, semistructured interviews will be undertaken with patients with low and high risk of CV disease. These interviews will be useful to have a deep understanding of the difficulties, desires, and needs in relation to interactions with practitioners and available services in healthcare settings. For proactive monitoring and follow-up of patients, a technological platform or App (CardioPlan), currently used for cardiac rehabilitation, will be restructured, which has a highly secure data repository located on the provider's server and then validated in a subgroup of patients (n=100).
Time frame: 3-6 years after index pregnancy
BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 3-6 years after index pregnancy
Waist/Hip ratio
Measurements in cm2 of waist and hip to calculate waist/hip ratio in cm2
Time frame: 3-6 years after index pregnancy
Heart rate
Measured in hpm
Time frame: 3-6 years after index pregnancy
Echocardiographic assesment
Performed by a cardiologist specialized in cardiac imaging according to the usual standard protocol. High-resolution images will be acquired and post-processed with dedicated software for the speckle tracking analysis.
Time frame: 3-6 years after index pregnancy
Myocardial deformation (strain)
measured by echocardiography is increasingly recognized as a more effective technique than conventional ejection fraction (EF) in detecting subtle changes in left ventricular (LV) function and in predicting outcomes. AutoStrain TOMTEC Philips EPIQ CVx ultrasound systemwould be used for the analysis.
Time frame: 3-6 years after index pregnancy
Carotid intima-media thickness
Transverse longitudinal evaluation of the common carotid artery, its bifurcation and internal carotid artery. Thickness of the intima layer is measured at the middle third of the common carotid artery and is considered the measurement between the tunica intima and tunica media, the innermost two layers of the wall of an artery.
Time frame: 3-6 years after index pregnancy
ophthalmic artery evaluation
The woman is placed in a supine position to rest for 5 minutes. A 7.5-MHz linear transducer is then placed transversely and gently over her closed upper eyelid after application of conduction gel. Color flow Doppler is used to identify the ophthalmic artery, which is found superior and medially to the hypoechoic band representing the optic nerve. Pulsed-wave Doppler is then used to record 3 to 5 similar waveforms. Doppler studies are performed twice in each eye, and the average of the 4 measurements is used for analysis.
Time frame: 3-6 years after index pregnancy
Cardiovascular markers in maternal blood
Venous blood samples will be collected without anticoagulant to obtain serum. Placental growth factor (PlGF) will be measured in pg/ml using automated electrochemiluminescence immunoassays on the Roche Cobas platform (Roche Diagnostics GmbH, Mannheim, Germany).Intra-and interassay coefficients of variation were found to be \<5%.
Time frame: 3-6 years after index pregnancy
Laboratory data measured in g/l
Venous blood samples and urine samples will be collected to measure hemoglobin and protein in urine
Time frame: 3-6 years after index pregnancy
Laboratory data measured in l/l
Venous blood samples will be collected to measure hematocrit
Time frame: 3-6 years after index pregnancy
Laboratory data measured in U/mcl
Venous blood samples will be collected to measure leukocytes and platalets
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mmol/l
Venous blood samples will be collected to measure potassium and sodium
Time frame: 3-6 years after index pregnancy
Laboratory data measured in %
Venous blood samples will be collected to measure glicated hemoglobin
Time frame: 3-6 years after index pregnancy
Laboratory data measured in U/L
Venous blood samples will be collected to measure alanine transaminases, aspartate aminotransferases and lactate dehydrogenase
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mg/l
Urine samples will be collected to measure albumin
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mUI/l
Venous blood samples will be collected to measure tirotropin and prolactin
Time frame: 3-6 years after index pregnancy
Ethnicity
Patient ethnicity
Time frame: 3-6 years after index pregnancy
Smoking status
Patient smoking status
Time frame: 3-6 years after index pregnancy
Menstrual type
Patient menstrual type and presence of menopause
Time frame: 3-6 years after index pregnancy
Diseases
Diabetes, obesity, and other maternal diseases associated with cardiovascular risk
Time frame: 3-6 years after index pregnancy
Interval from index preganancy
interval in years from index pregnancy.
Time frame: 3-6 years after index pregnancy
Gestational age at delivery
Gestational age at delivery in index pregnancy
Time frame: 3-6 years after index pregnancy
Mode of delivery
mode of delivery at index pregnancy,
Time frame: 3-6 years after index pregnancy
Labor induction
labor induction at index pregnancy
Time frame: 3-6 years after index pregnancy
Child's gender
Child's gender in index pregnancy
Time frame: 3-6 years after index pregnancy
Birth weight percentile
birth weight percentile in index pregnancy
Time frame: 3-6 years after index pregnancy
Birth weight
Child's birth weight at index pregancy.
Time frame: 3-6 years after index pregnancy
APGAR score
5-minute Apgar score in index pregnancy. Apgar score measures appareance, pulse, grimance, acivity and respiratory effort. For each chriteria newborns can receive a punctuation from 0 to 2, qhere 2 is the better punctuation.
Time frame: 3-6 years after index pregnancy
Blood preassure during pregnancy
Blood preassure druing index pregnancy
Time frame: 3-6 years after index pregnancy
Weight during pregnancy
Weight during index pregnancy.
Time frame: 3-6 years after index pregnancy
Plan to share: Undecided
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.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau →