Diastolic Dysfunction in the Pregnant Woman With Preeclampsia
Conditions: Preeclampsia, Severe Preeclampsia
Sponsor: University Tunis El Manar

ClinicalTrials.gov Study Protocol 
Official Title: Diastolic Dysfunction in the Pregnant Woman with Preeclampsia: A 
Prospective Observational Study at the Maternity and Neonatology Center of Tunis 
Short Title: Diastolic Dysfunction in Preeclampsia 
NCT Number: [to be assigned] 
Date: August 2025 
Sponsor/Responsible Party: Maternity and Neonatology Center of Tunis 
Principal Investigator: [DR Sarra zarrouk, MD, Maternity and Neonatology Center of Tunis, 
Tunisia, zarrouk.sarah958@gmail.com] 
 
 

1. Objective 
The objective of this study is to evaluate diastolic function in pregnant women with 
preeclampsia and to compare findings with normotensive pregnant women. 
2. Study Design 
- Study Type: Observational (Case-Control) 
- Study Model: Case-Control, two cohorts (Preeclampsia vs. Normotensive) 
- Time Perspective: Prospective 
- Enrollment: 80 participants (40 in each cohort) 
- Follow-up Duration: Until delivery and immediate postpartum (up to 7 days) 
3. Study Setting and Duration 
This study was conducted within the Anesthesia-Resuscitation and Gynecology-Obstetrics 
Departments (A, B, C, and D) of the Maternity and Neonatology Center in Tunis, Tunisia, 
over a 5-month period from March 2025 to June 2025. 
4. Eligibility Criteria 
Inclusion Criteria: 
- Pregnant women aged 18–45 years 
- Third trimester of pregnancy 
- Group A: women diagnosed with preeclampsia (≥140/90 mmHg after 20 weeks + 
proteinuria ≥300 mg/24h, with or without severity criteria) 
- Group B: normotensive pregnant women without proteinuria (<300 mg/24h if tested) 
 
Exclusion Criteria: 
- Pre-existing cardiovascular disease (valvulopathy, cardiomyopathy, EF <50%) 
- Congenital heart disease, arrhythmia, prior cardiac surgery 
- Chronic hypertension (before 20 weeks) 
- Pulmonary hypertension (pre- or post-capillary) 
- Systemic disease with cardiac involvement (SLE, Behçet’s disease) 
- Technical difficulty preventing echocardiographic evaluation 
- Unusable medical records or diagnostic uncertainty 
- Gestational hypertension without preeclampsia 
5. Study Procedures 
Data Collection: 
- Demographics, medical history, clinical and biological data collected using standardized 
forms. 
- Echocardiographic parameters recorded according to ASE/EACVI 2016 guidelines. 

 
Echocardiographic Parameters Assessed: 
- Transmitral Doppler flow (E wave, A wave, E/A ratio, Deceleration Time) 
- Tissue Doppler imaging (E′ septal, E′ lateral, A′, S′) 
- Indexed left atrial volume 
- Maximum tricuspid regurgitation velocity (Vmax TR) 
 
Classification of Diastolic Function: 
- Normal 
- Indeterminate 
- Diastolic Dysfunction (Grade I = impaired relaxation; Grade II = pseudonormal; Grade III = 
restrictive) 
6. Outcome Measures 
Primary Outcome: 
- Title: Prevalence of left ventricular diastolic dysfunction in preeclamptic women 
- Description: Echocardiographic evaluation based on ASE/EACVI 2016 criteria 
- Time Frame: At echocardiographic evaluation during the third trimester 
 
Secondary Outcomes: 
1. Comparison of diastolic parameters between preeclamptic and normotensive groups (E′, 
E/E′, LA volume, TR velocity). 
2. Association between diastolic dysfunction and maternal symptoms (dyspnea, 
palpitations, pulmonary edema). 
3. Correlation between severity of preeclampsia and degree of diastolic dysfunction. 
- Time Frame: During pregnancy and up to 7 days postpartum. 
7. Statistical Analysis Plan 
- Continuous variables expressed as mean ± SD; compared using Student’s t-test or Mann-
Whitney U test. 
- Categorical variables expressed as counts (%) and compared using Chi-square or Fisher’s 
exact test. 
- p < 0.05 considered statistically significant. 
- Subgroup analysis: association between severity of preeclampsia and prevalence of 
diastolic dysfunction. 
8. Ethical Considerations 
- Study approved by the Local Ethics Committee of the Maternity and Neonatology Center of 
Tunis. 

- Written informed consent obtained from all participants. 
- Confidentiality, anonymity, and protection of personal data ensured. 
9. References 
ASE/EACVI 2016 Guidelines on Diastolic Function. 
Melchiorre K et al. Circulation. 2011. 
Guirguis G et al. J Am Soc Echocardiogr. 2015.