Diastolic Dysfunction in the Pregnant Woman With Preeclampsia
| Registry | NCT07190846 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 80 (Actual) |
| Sponsor | University Tunis El Manar (Other) |
| Conditions | Preeclampsia, Severe Preeclampsia |
| Interventions | No Intervention (Observational Echocardiographic Evaluation) (Other) |
| Dates | start 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 in Tunisia |
Related Papers Related Patents Related Grants Related Experts
All trials for Preeclampsia All trials for Severe Preeclampsia All trials of No Intervention (Observational Echocardiographic Evaluation)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Preeclampsia Group | Other: No Intervention (Observational Echocardiographic Evaluation) | Pregnant women in the third trimester diagnosed with preeclampsia (mostly severe forms), aged 18-45 years, without pre-existing cardiovascular disease or other exclusion criteria. | |
| Control Group | Other: No Intervention (Observational Echocardiographic Evaluation) | Normotensive pregnant women in the third trimester, aged 18-45 years, without cardiovascular disease or other exclusion criteria. |
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Pregnant women aged 18-45 years * Third trimester of pregnancy * Group A: women diagnosed with preeclampsia according to international criteria (blood pressure ≥ 140/90 mmHg after 20 weeks with proteinuria or signs of severity) * Group B (controls): normotensive pregnant women without proteinuria or cardiovascular disease * Signed informed consent Exclusion Criteria: * Known pre-existing cardiovascular disease (structural heart disease, heart failure, chronic hypertension complicated) * Left ventricular ejection fraction < 45% * Pre-gestational diabetes * Chronic kidney disease * Multiple pregnancy * Other severe comorbidities that could affect cardiac function independently of preeclampsia
| Facility | City | Country | Status |
|---|---|---|---|
| Maternity and Neonatology Center of Tunis | Tunis | Tunisia |