Cardiovascular (CV) RiskCARDIOMOMNCT07356817
Cardiovascular Risk Assessment in Young Women After Index Pregnancy With and Without Placental Complications
An observational study of Cardiovascular (CV) Risk and Preeclampsia (PE), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk, Preeclampsia (PE), Fetal Weight
- How many people
- 1,260 participants
- Where
- 1 siteSpain
- Study dates
- 28 Aug 2023to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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.
Who cannot join
- Unwillingness to participate in this study
- Probability of loss to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i de Sant Pau
Barcelona, 08025
Pablo García Manau, PhD, +34 627813346, pgarciama@santpau.cat
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular (CV) Risk, Preeclampsia (PE), Fetal Weight
- Keywords
- preeclampsia, Cardiovascular Risk, app
- Medical subject headings
- Pre-Eclampsia, Fetal Weight, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young women with an index pregnancy with and without placental complications | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg)
Measured: 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
Measured: 3-6 years after index pregnancy
Biochemical cardiac markers
Abnormal biochemical cardiac markers: NTproBNP >300 ng/L or high-sensitivity troponin>30 ng/L
Measured: 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)
Measured: 3-6 years after index pregnancy
Other cardiovascular major events
Cardiovascular major events (ictus, coronary artery disease, cardiac insufficiency or myocardiopathy)
Measured: 3-6 years after index pregnancy
Secondary outcomes (45)
Age
Patient age
Measured: 3-6 years after index pregnancy
Pregnancy complications
Preeclampsia, pregnancy complications, presence of fetal distress, perinatal mortality, neonatal morbidity, and neonatal mortality.
Measured: 3-6 years after index pregnancy
Antrophometric measurements
Percentages of body fat, muscle mass, visceral fat
Measured: 3-6 years after index pregnancy
Blood pressure
Systolic and Dyastolic blood pressure
Measured: 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.
Measured: 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%.
Measured: 3-6 years after index pregnancy
Laboratory data measured in mg/dl
glucose, uric acid, creatinine, VLDL, LDL, HDL, total cholesterol, triglycerides
Measured: 3-6 years after index pregnancy
Cardiovascular assessment according to IBERLIFERISK score
A score >50% is considered as a high-risk for CVD.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-6 years after index pregnancy
Smoking habit
evaluated by the Fagerström Questionnaire, validated questionnaire for quantifying dependence on smoking in our population.
Measured: 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).
Measured: 3-6 years after index pregnancy
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: 3-6 years after index pregnancy
Waist/Hip ratio
Measurements in cm2 of waist and hip to calculate waist/hip ratio in cm2
Measured: 3-6 years after index pregnancy
Heart rate
Measured in hpm
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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
Measured: 3-6 years after index pregnancy
Laboratory data measured in l/l
Venous blood samples will be collected to measure hematocrit
Measured: 3-6 years after index pregnancy
Laboratory data measured in U/mcl
Venous blood samples will be collected to measure leukocytes and platalets
Measured: 3-6 years after index pregnancy
Laboratory data measured in mmol/l
Venous blood samples will be collected to measure potassium and sodium
Measured: 3-6 years after index pregnancy
Laboratory data measured in %
Venous blood samples will be collected to measure glicated hemoglobin
Measured: 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
Measured: 3-6 years after index pregnancy
Laboratory data measured in mg/l
Urine samples will be collected to measure albumin
Measured: 3-6 years after index pregnancy
Laboratory data measured in mUI/l
Venous blood samples will be collected to measure tirotropin and prolactin
Measured: 3-6 years after index pregnancy
Ethnicity
Patient ethnicity
Measured: 3-6 years after index pregnancy
Smoking status
Patient smoking status
Measured: 3-6 years after index pregnancy
Menstrual type
Patient menstrual type and presence of menopause
Measured: 3-6 years after index pregnancy
Diseases
Diabetes, obesity, and other maternal diseases associated with cardiovascular risk
Measured: 3-6 years after index pregnancy
Interval from index preganancy
interval in years from index pregnancy.
Measured: 3-6 years after index pregnancy
Gestational age at delivery
Gestational age at delivery in index pregnancy
Measured: 3-6 years after index pregnancy
Mode of delivery
mode of delivery at index pregnancy,
Measured: 3-6 years after index pregnancy
Labor induction
labor induction at index pregnancy
Measured: 3-6 years after index pregnancy
Child's gender
Child's gender in index pregnancy
Measured: 3-6 years after index pregnancy
Birth weight percentile
birth weight percentile in index pregnancy
Measured: 3-6 years after index pregnancy
Birth weight
Child's birth weight at index pregancy.
Measured: 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.
Measured: 3-6 years after index pregnancy
Blood preassure during pregnancy
Blood preassure druing index pregnancy
Measured: 3-6 years after index pregnancy
Weight during pregnancy
Weight during index pregnancy.
Measured: 3-6 years after index pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start28 Aug 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,260 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Barcelona Institute for Global Health
- Responsible party
- Sponsor
- Investigators
- Elisa Llurba, PhD, Principal investigator, Hospital de la Sant Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356817
- Sponsor's protocol ID
- IIBSP-MOM-2022-87
- Acronym
- CARDIOMOM
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brotons C, Moral I, Fernandez D, Puig M, Calvo Bonacho E, Martinez Munoz P, Catalina Romero C, Quevedo Aguado LJ. Estimation of Lifetime Risk of Cardiovascular Disease (IBERLIFERISK): A New Tool for Cardiovascular Disease Prevention in Primary Care. Rev Esp Cardiol (Engl Ed). 2019 Jul;72(7):562-568. doi: 10.1016/j.rec.2018.05.028. Epub 2018 Aug 7. English, Spanish.
PubMed 30097396Ferencik M, Pencina KM, Liu T, Ghemigian K, Baltrusaitis K, Massaro JM, D'Agostino RB Sr, O'Donnell CJ, Hoffmann U. Coronary Artery Calcium Distribution Is an Independent Predictor of Incident Major Coronary Heart Disease Events: Results From the Framingham Heart Study. Circ Cardiovasc Imaging. 2017 Oct;10(10):e006592. doi: 10.1161/CIRCIMAGING.117.006592.
PubMed 28956774Saenger AK, Beyrau R, Braun S, Cooray R, Dolci A, Freidank H, Giannitsis E, Gustafson S, Handy B, Katus H, Melanson SE, Panteghini M, Venge P, Zorn M, Jarolim P, Bruton D, Jarausch J, Jaffe AS. Multicenter analytical evaluation of a high-sensitivity troponin T assay. Clin Chim Acta. 2011 Apr 11;412(9-10):748-54. doi: 10.1016/j.cca.2010.12.034. Epub 2011 Jan 8.
PubMed 21219893Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.
PubMed 16293638Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.
PubMed 29146535
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Assessment in Young Women After Index Pregnancy With and Without Placental Complications
- ClinicalTrials.gov ID
- NCT07356817
- Acronym / sponsor ID
- CARDIOMOM / IIBSP-MOM-2022-87
- Conditions
- Cardiovascular (CV) Risk, Preeclampsia (PE), Fetal Weight
- Keywords
- preeclampsia, Cardiovascular Risk, app
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Barcelona Institute for Global Health
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young women with an index pregnancy with and without placental complications | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Unwillingness to participate in this study
- Probability of loss to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension
Time frame: 3-6 years after index pregnancy
Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg)
Abnormal cardiac function
Time frame: 3-6 years after index pregnancy
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
Time frame: 3-6 years after index pregnancy
Abnormal biochemical cardiac markers: NTproBNP >300 ng/L or high-sensitivity troponin>30 ng/L
Coronary artery disease
Time frame: 3-6 years after index pregnancy
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)
Other cardiovascular major events
Time frame: 3-6 years after index pregnancy
Cardiovascular major events (ictus, coronary artery disease, cardiac insufficiency or myocardiopathy)
45 secondary outcomes
Age
Time frame: 3-6 years after index pregnancy
Pregnancy complications
Time frame: 3-6 years after index pregnancy
Antrophometric measurements
Time frame: 3-6 years after index pregnancy
Blood pressure
Time frame: 3-6 years after index pregnancy
Computer tomography (CCT) myocardial perfusion imaging and RM Quantitative Myocardial Perfusion
Time frame: 3-6 years after index pregnancy
Cardiovascular markers in maternal blood
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mg/dl
Time frame: 3-6 years after index pregnancy
Cardiovascular assessment according to IBERLIFERISK score
Time frame: 3-6 years after index pregnancy
Hair sampling for cortisol determination
Time frame: 3-6 years after index pregnancy
Diet and nutrition
Time frame: 3-6 years after index pregnancy
Physical activity
Time frame: 3-6 years after index pregnancy
Stress
Time frame: 3-6 years after index pregnancy
Mental health
Time frame: 3-6 years after index pregnancy
Smoking habit
Time frame: 3-6 years after index pregnancy
Women experiences and eHealth
Time frame: 3-6 years after index pregnancy
BMI
Time frame: 3-6 years after index pregnancy
Waist/Hip ratio
Time frame: 3-6 years after index pregnancy
Heart rate
Time frame: 3-6 years after index pregnancy
Echocardiographic assesment
Time frame: 3-6 years after index pregnancy
Myocardial deformation (strain)
Time frame: 3-6 years after index pregnancy
Carotid intima-media thickness
Time frame: 3-6 years after index pregnancy
ophthalmic artery evaluation
Time frame: 3-6 years after index pregnancy
Cardiovascular markers in maternal blood
Time frame: 3-6 years after index pregnancy
Laboratory data measured in g/l
Time frame: 3-6 years after index pregnancy
Laboratory data measured in l/l
Time frame: 3-6 years after index pregnancy
Laboratory data measured in U/mcl
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mmol/l
Time frame: 3-6 years after index pregnancy
Laboratory data measured in %
Time frame: 3-6 years after index pregnancy
Laboratory data measured in U/L
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mg/l
Time frame: 3-6 years after index pregnancy
Laboratory data measured in mUI/l
Time frame: 3-6 years after index pregnancy
Ethnicity
Time frame: 3-6 years after index pregnancy
Smoking status
Time frame: 3-6 years after index pregnancy
Menstrual type
Time frame: 3-6 years after index pregnancy
Diseases
Time frame: 3-6 years after index pregnancy
Interval from index preganancy
Time frame: 3-6 years after index pregnancy
Gestational age at delivery
Time frame: 3-6 years after index pregnancy
Mode of delivery
Time frame: 3-6 years after index pregnancy
Labor induction
Time frame: 3-6 years after index pregnancy
Child's gender
Time frame: 3-6 years after index pregnancy
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 21 Jan 2026.
- Background: PubMed 30097396Brotons C, Moral I, Fernandez D, Puig M, Calvo Bonacho E, Martinez Munoz P, Catalina Romero C, Quevedo Aguado LJ. Estimation of Lifetime Risk of Cardiovascular Disease (IBERLIFERISK): A New Tool for Cardiovascular Disease Prevention in Primary Care. Rev Esp Cardiol (Engl Ed). 2019 Jul;72(7):562-568. doi: 10.1016/j.rec.2018.05.028. Epub 2018 Aug 7. English, Spanish.
- Background: PubMed 28956774Ferencik M, Pencina KM, Liu T, Ghemigian K, Baltrusaitis K, Massaro JM, D'Agostino RB Sr, O'Donnell CJ, Hoffmann U. Coronary Artery Calcium Distribution Is an Independent Predictor of Incident Major Coronary Heart Disease Events: Results From the Framingham Heart Study. Circ Cardiovasc Imaging. 2017 Oct;10(10):e006592. doi: 10.1161/CIRCIMAGING.117.006592.
- Background: PubMed 21219893Saenger AK, Beyrau R, Braun S, Cooray R, Dolci A, Freidank H, Giannitsis E, Gustafson S, Handy B, Katus H, Melanson SE, Panteghini M, Venge P, Zorn M, Jarolim P, Bruton D, Jarausch J, Jaffe AS. Multicenter analytical evaluation of a high-sensitivity troponin T assay. Clin Chim Acta. 2011 Apr 11;412(9-10):748-54. doi: 10.1016/j.cca.2010.12.034. Epub 2011 Jan 8.
- Background: PubMed 16293638Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.
- Background: PubMed 29146535Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.
- IBERLIFERISK scoreLink provided by the sponsor.
- REGICOR questionnaireLink provided by the sponsor.
- Phisycal activity questionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Elisa Llurba, PhD principal investigator
Hospital de la Sant Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular (CV) Risk and Preeclampsia (PE), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 2 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Elisa Llurba Olivé, PhD (+34 935534078, ellurba@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: 3-6 years after index pregnancy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07356817, which also lists 5 linked publications.
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 21 Jan 2026.