Cardiovascular Risk Assessment in Young Women After Index Pregnancy With and Without Placental Complications

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,260 Participants
are grouped into 1 trial group
Group A: Young women with an index pregnancy with and without placental complications

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Age

Patient age

Time frame
3-6 years after index pregnancy
2

Pregnancy complications

Preeclampsia, pregnancy complications, presence of fetal distress, perinatal mortality, neonatal morbidity, and neonatal mortality.

Time frame
3-6 years after index pregnancy
3

Antrophometric measurements

Percentages of body fat, muscle mass, visceral fat

Time frame
3-6 years after index pregnancy
4

Blood pressure

Systolic and Dyastolic blood pressure

Time frame
3-6 years after index pregnancy

Other outcomes

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