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
| Type | Name | Description |
|---|---|---|
| OTHER | No 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.