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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preeclampsia Group | 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 | Normotensive pregnant women in the third trimester, aged 18-45 years, without cardiovascular disease or other exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention (Observational Echocardiographic Evaluation) | Other | This is an observational study. No therapeutic intervention is administered. Participants undergo standard echocardiographic assessment of left ventricular diastolic function during pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women | Echocardiographic assessment of diastolic function according to ASE/EACVI 2016 criteria, including parameters E, A, E/A ratio, septal and lateral e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity. | At baseline, during third-trimester pregnancy hospital evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women in the third trimester recruited at the Center of Maternity and Neonatology of Tunis, including 40 with preeclampsia (mainly severe forms) and 40 normotensive controls.
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| Name | Affiliation | Role |
|---|---|---|
| Ben marzouk sofiene | Maternity and Neonatology Center of Tunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity and Neonatology Center of Tunis | Tunis | 1007 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28906533 | Result | Soma-Pillay P, Louw MC, Adeyemo AO, Makin J, Pattinson RC. Cardiac diastolic function after recovery from pre-eclampsia. Cardiovasc J Afr. 2018 Jan/Feb 23;29(1):26-31. doi: 10.5830/CVJA-2017-031. Epub 2017 Aug 31. | |
| 26597754 | Result | Guirguis GF, Aziz MM, Boccia Liang C, Williams SF, Apuzzio JJ, Bilinski R, Mornan AJ, Shah LP. Is preeclampsia an independent predictor of diastolic dysfunction? A retrospective cohort study. Pregnancy Hypertens. 2015 Oct;5(4):359-61. doi: 10.1016/j.preghy.2015.10.001. Epub 2015 Oct 9. |
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The investigators have not yet decided whether individual participant data (IPD) from this study will be shared. Decisions regarding data sharing will depend on future institutional policies, ethical considerations, and requests from qualified researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2025 | Sep 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| 29957219 | Result | Vaught AJ, Kovell LC, Szymanski LM, Mayer SA, Seifert SM, Vaidya D, Murphy JD, Argani C, O'Kelly A, York S, Ouyang P, Mukherjee M, Zakaria S. Acute Cardiac Effects of Severe Pre-Eclampsia. J Am Coll Cardiol. 2018 Jul 3;72(1):1-11. doi: 10.1016/j.jacc.2018.04.048. |
| 21098311 | Result | Melchiorre K, Sutherland GR, Baltabaeva A, Liberati M, Thilaganathan B. Maternal cardiac dysfunction and remodeling in women with preeclampsia at term. Hypertension. 2011 Jan;57(1):85-93. doi: 10.1161/HYPERTENSIONAHA.110.162321. Epub 2010 Nov 22. |
| 27037982 | Result | Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |