Clinical Trials Directory

Trials / Completed

CompletedNCT07190846

Diastolic Dysfunction 2025

Diastolic Dysfunction in the Pregnant Woman With Preeclampsia

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
University Tunis El Manar · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

This is a prospective observational study conducted at the Maternity and Neonatology Center of Tunis to evaluate cardiac diastolic function in women with preeclampsia compared with normotensive pregnant women. A total of 80 pregnant women in the third trimester were enrolled, including 40 with preeclampsia (mostly severe forms) and 40 healthy controls. All participants underwent standardized transthoracic echocardiography to assess left ventricular diastolic function according to the 2016 ASE/EACVI recommendations.

Detailed description

Preeclampsia is a major hypertensive disorder of pregnancy associated with increased maternal morbidity and mortality, as well as long-term cardiovascular risk. Cardiac remodeling in this context is characterized by increased vascular stiffness and concentric left ventricular hypertrophy, which may lead to subclinical diastolic dysfunction despite preserved systolic function. This prospective observational study was designed to evaluate left ventricular diastolic function in women with preeclampsia compared to normotensive pregnant women. Eighty participants in the third trimester of pregnancy were included: 40 diagnosed with preeclampsia (mainly severe forms) and 40 normotensive controls. Women with pre-existing cardiovascular disease, diabetes, renal impairment, or multiple pregnancies were excluded. All participants underwent standardized echocardiographic evaluation in accordance with the 2016 recommendations of the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI). Diastolic function was assessed based on transmitral Doppler indices (E and A waves, E/A ratio), tissue Doppler imaging (septal and lateral e' velocities), E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity.

Conditions

Interventions

TypeNameDescription
OTHERNo Intervention (Observational Echocardiographic Evaluation)This is an observational study. No therapeutic intervention is administered. Participants undergo standard echocardiographic assessment of left ventricular diastolic function during pregnancy.

Timeline

Start date
2025-03-01
Primary completion
2025-07-31
Completion
2025-07-31
First posted
2025-09-24
Last updated
2025-09-24

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT07190846. Inclusion in this directory is not an endorsement.