Transcranial Doppler in Preeclampsia and Its Complications.

NCT07646561 | Completed

• 1 other identifier: DTC pre eclampsie
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. It is defined by new-onset hypertension after 20 weeks of gestation, often associated with proteinuria and/or systemic complications such as thrombocytopenia, renal impairment, hepatic dysfunction, neurological symptoms, pulmonary edema, or intrauterine growth restriction. Neurological involvement is particularly severe, as it may progress to eclampsia, intracerebral hemorrhage, or ischemic stroke. Detecting early cerebral hemodynamic changes is therefore essential. Transcranial Doppler (TCD) is a non-invasive ultrasound technique that measures cerebral blood flow velocities, particularly in the middle cerebral artery (MCA). It provides systolic, diastolic, and mean velocity values, and calculates indices such as pulsatility index (PI), resistance index (RI), cerebral perfusion pressure (CPP), resistance area product (RAP), cerebral flow index (CFI), and Lindegaard index (LI). These parameters can detect impaired cerebral autoregulation, hyperemia, vasospasm, or cerebral hypoperfusion. Although several studies suggest that preeclampsia is associated with altered cerebral hemodynamics, the diagnostic and prognostic role of TCD remains insufficiently defined. The objective of this prospective, observational, case-control study is to evaluate the diagnostic and prognostic value of TCD in preeclampsia and its complications. The study will be conducted at the Maternity and Neonatology Center of Tunis (Departments of Anesthesia, Intensive Care, and Gynecology-Obstetrics A-D) over six months, from January to June 2025. Participants will be pregnant women in their third trimester, divided into two groups:

• Group A: preeclamptic women, defined by hypertension and proteinuria after 20 weeks of gestation, or hypertension/proteinuria with at least one severity criterion (hematologic, hepatic, renal, pulmonary, neurological, or fetal).
• Group B: normotensive, non-preeclamptic controls. Exclusion criteria include chronic hypertension, chronic kidney disease, epilepsy, hematologic disease, cardiac or liver disease, COPD, severe anemia, technical difficulties preventing TCD, loss to follow-up, or diagnostic uncertainty. Women with isolated gestational hypertension will also be excluded. TCD will be performed via the temporal window using a 2 MHz pulsed Doppler probe, mainly focusing on the MCA. In Group A, measurements will be obtained before and after antihypertensive therapy, before and after magnesium sulfate administration when indicated, and before and after any complications. In Group B, a single TCD will be performed during the third trimester. The study will compare cerebral blood flow velocities and indices between groups and monitor their evolution over time. Data interpretation will allow classification of findings into patterns such as systemic hypoperfusion, cerebral hypoperfusion with elevated intracranial pressure, hyperemia, or vasospasm. The expected outcome is to establish whether TCD can serve as a reliable diagnostic and prognostic tool in preeclampsia. The results will contribute to a better understanding of cerebrovascular physiology in this condition and may help identify women at higher risk of neurological or systemic complications. Ultimately, this work aims to highlight TCD as a simple, reproducible, and non-invasive tool for clinical management and risk stratification in preeclampsia.

Conditions

Pre Eclampsia

Keywords

pre eclampsia; transcranial Doppler; Magnesium; eclampsia

Outcome Measures

Primary Outcomes (1)

• Pulsatility index (IP) of the middle cerebral artery (MCA)

  pulsatility index (PI) will be measured in the MCA using transcranial Doppler ultrasound in pregnant women with preeclampsia and in healthy pregnant women. The study aims to evaluate the diagnostic and prognostic value of this parameter: for women with preeclampsia, to identify severe forms of the disease, and for healthy pregnant women, to assess the risk of developing preeclampsia after the Doppler measurement.

  Measured during the third trimester

Secondary Outcomes (8)

• - pulsatility index (IP)measured in the posterior cerebral artery (PCA)

  At study enrollement

• cerebral blood flow index in the middle cerebral artery

  at study enrollement

• cerebral blood flow index in the posterior cerebral artery

  at study enrollement

• correlation between middle cerebral artery pulsatiliy index and severityof preeclmapsia

  at study enrollement

• correlation between transcranial doppler parameters and blood pressure levels

  at study enrollement

Study Arms (2)

• Group A: Pregnant women with preeclampsia in the third trimester

• Group A: patients with pre eclampsia, defined as follows: Patients with Systolic Blood Pressure greater or equal than140 mmHg and or Diastolic Blood Pressure greater or equal than 90 mmHg appearing after 20 weeks of gestation, WITH the presence of 24hour proteinuria greater or equal than300 mg per 24h, OR Patients with SBP greater or equal140 mmHg and or DBP greater or equal than 90 mmHg or 24hour proteinuria greater or equal than 300 mg per24h, WITH at least one of the following criteria Thrombocytopenia less than 100,000 permm³ Liver cytolysis greater than 2 times normal values Hemolytic anemia schistocytes, LDH more than 600 Serum creatinine mo 90 µmol per L and oliguria less or equal than500 ml per 24h excluding any functional or obstructive cause Acute pulmonary edema Subcapsular liver hematoma Neurological or sensory signs Eclampsia Severe intrauterine growth restriction

Diagnostic Test: Transcranial doppler ultrasound

Group B: Non-Preeclamptic Normotensive Patients

Patients with SBP less than 140 mmHg and DBP less than 90 mmHg, with no clinical or biological abnormalities suggesting severe preeclampsia, and a negative 24hour proteinuria test if performed.

Diagnostic Test: Transcranial doppler ultrasound

Interventions

Transcranial doppler ultrasound DIAGNOSTIC_TEST

This intervention involves performing Transcranial Doppler (TCD) ultrasound on pregnant women with preeclampsia in the third trimester. TCD is a non-invasive imaging technique used to assess cerebral blood flow velocity and detect potential cerebrovascular complications. The procedure is performed at the bedside, using standard clinical protocols. No contrast agents or medications are administered. This intervention is distinct from other ultrasound procedures as it specifically targets intracranial arteries and provides real-time hemodynamic data relevant to preeclampsia.

Also known as: TCD, Doppler ultrasound

Group B: Non-Preeclamptic Normotensive Patients; • Group A: Pregnant women with preeclampsia in the third trimester

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in their third trimester (28 weeks or more) participating in this study are divided into two groups: * Group A: Women diagnosed with preeclampsia according to standard clinical and laboratory criteria, including elevated blood pressure and proteinuria, with or without severe features. * Group B: Healthy, normotensive pregnant women without signs of preeclampsia. Participants are included after providing informed consent and are monitored for cerebral blood flow parameters using transcranial Doppler ultrasound.

You may qualify if:

• Consenting pregnant women in their third trimester (28 weeks of gestation or more)
• Group A: Patients with preeclampsia, defined as:
• Systolic Blood Pressure (SBP) equal to or greater than 140 mmHg and/or Diastolic Blood Pressure (DBP) equal to or greater than 90 mmHg appearing after 20 weeks of gestation with 24-hour proteinuria equal to or greater than 300 mg/24h, or
• SBP equal to or greater than 140 mmHg and/or DBP equal to or greater than 90 mmHg or 24-hour proteinuria equal to or greater than 300 mg/24h with at least one of the following
• Thrombocytopenia, platelets below 100,000 per cubic millimeter
• Liver cytolysis, AST or ALT more than 2 times normal values
• Hemolytic anemia (schistocytes present, LDH above 600)
• Serum creatinine equal to or greater than 90 micromoles per liter and oliguria equal to or less than 500 milliliters per 24 hours, excluding functional or obstructive causes
• Acute pulmonary edema
• Subcapsular liver hematoma
• Neurological or sensory signs (headache, blurred vision, tinnitus, hyperreflexia, diffuse polykinetic reflexes)
• Eclampsia
• Severe intrauterine growth restriction
• Group B: Healthy, normotensive pregnant women
• SBP less than 140 mmHg and DBP less than 90 mmHg

You may not qualify if:

• Multiple pregnancy (twins, triplets, etc.)
• History of significant neurological or cardiovascular disease
• Active infection or major medical complication
• Allergy or contraindication to antihypertensive therapy or magnesium sulfate
• Refusal to provide informed consent

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunis maternity and neonatology center, ministery of public health, Tunis ,1007

Tunis, Tunisia

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Interventions

Ultrasonography, Doppler, Transcranial; Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: June 12, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: June 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)