- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07646561
Transcranial Doppler in Preeclampsia and Its Complications. (DTC-PE)
the Diagnostic and Prognostic Value of Transcranial Doppler in Preeclampsia and Its Complications.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Preeclampsia is a complex multisystem disorder of pregnancy, and neurological complications are among the most severe outcomes, including eclampsia, cerebrovascular accidents, and altered cerebral perfusion. Understanding cerebral hemodynamics in preeclampsia is essential for early identification of high-risk patients and timely intervention.
Transcranial Doppler (TCD) provides real-time, non-invasive measurements of cerebral blood flow velocities and derived indices, which reflect cerebral autoregulation, vascular resistance, and perfusion pressure. These parameters allow detection of pathophysiological changes such as cerebral hypoperfusion, hyperemia, vasospasm, or elevated intracranial pressure, which are relevant for the management of preeclampsia.
This study is designed as a prospective, observational, case-control investigation to evaluate the diagnostic and prognostic value of TCD in preeclamptic women. It will be conducted over six months at the Maternity and Neonatology Center of Tunis, including the Departments of Anesthesia, Intensive Care, and Gynecology-Obstetrics (A-D).
Eligible participants are women in their third trimester of pregnancy. Women with preexisting conditions affecting cerebral hemodynamics, chronic hypertension, renal, cardiac, hepatic, hematologic disease, COPD, or severe anemia will be excluded. Participants will undergo TCD using a 2 MHz pulsed Doppler probe via the temporal window, primarily assessing the middle cerebral artery.
In preeclamptic patients, serial TCD measurements will be performed to monitor changes before and after antihypertensive therapy, magnesium sulfate administration (if indicated), and any clinical complications. Normotensive control patients will undergo a single TCD assessment. Measured parameters include systolic, diastolic, and mean velocities, as well as resistance and pulsatility indices, cerebral perfusion pressure, cerebral flow index, and Lindegaard index.
Data analysis will focus on identifying hemodynamic patterns associated with increased cerebral risk, and correlating TCD findings with clinical outcomes and therapeutic interventions. This approach aims to evaluate whether TCD can serve as a reliable, non-invasive tool to stratify risk and guide management in preeclamptic women.
The study will contribute to understanding cerebrovascular physiology in preeclampsia and may provide evidence to support the integration of TCD into routine monitoring of high-risk pregnancies, potentially improving maternal and fetal outcomes.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Tunis, Tunisia
- Tunis maternity and neonatology center, ministery of public health, Tunis ,1007
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- 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
- No clinical or biological signs of severe preeclampsia
- Negative 24-hour proteinuria test, less than 300 mg/24h, if performed
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
• 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
|
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.
Altri nomi:
|
|
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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pulsatility index (IP) of the middle cerebral artery (MCA)
Lasso di tempo: Measured during the third trimester
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
- pulsatility index (IP)measured in the posterior cerebral artery (PCA)
Lasso di tempo: At study enrollement
|
pulsatility index (PI) will be measured in the PCA 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.
|
At study enrollement
|
|
cerebral blood flow index in the middle cerebral artery
Lasso di tempo: at study enrollement
|
cerebral blood flow index measured in the middle cerebral artery
|
at study enrollement
|
|
cerebral blood flow index in the posterior cerebral artery
Lasso di tempo: at study enrollement
|
cerebral blood flow index measured in the posterior cerebral artery
|
at study enrollement
|
|
correlation between middle cerebral artery pulsatiliy index and severityof preeclmapsia
Lasso di tempo: at study enrollement
|
association between middle cerebral artery pulsatiliy index values and clinical severity of preeclampsia
|
at study enrollement
|
|
correlation between transcranial doppler parameters and blood pressure levels
Lasso di tempo: at study enrollement
|
association between doppler-derived cerebral hemodynamic parameters and systolic/diastolic blood pressure
|
at study enrollement
|
|
neurological manifestations associatedwith abnormal transcranial doppler findings
Lasso di tempo: During hospitalisation
|
Relationship between Doppler parameters and neurological manifestations such as visual disturbance ,headache , eclampsia ...
|
During hospitalisation
|
|
Effect of antihypertensive treatement on transcranial dopller parameters
Lasso di tempo: before treatement and 24 hours after treatement initiation
|
change in doppler parameters after initiation of antihypertensive therapy
|
before treatement and 24 hours after treatement initiation
|
|
effect of magnesium sulfate on transcranial doppler parameters
Lasso di tempo: before treatement and 24 hours after treatement initiation
|
change in doppler parameters following magnesiumbsulfae administration in severe preeclampsia
|
before treatement and 24 hours after treatement initiation
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali femminili e complicanze della gravidanza
- Complicazioni della gravidanza
- Ipertensione, indotta dalla gravidanza
- Eclampsia
- Preeclampsia
- Tecniche investigative
- Tecniche e procedure diagnostiche
- Diagnosi
- Imaging diagnostico
- Tecniche diagnostiche, neurologiche
- Radiografia
- Ecografia
- Ecoencefalografia
- Neuroradiografia
- Neuroimaging
- Ecografia, Doppler, Transcranica
- Ultrasonografia Doppler
Altri numeri di identificazione dello studio
- DTC pre eclampsie
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Preeclampsia
-
Loughborough UniversityFitoplancton Marino, S.L.CompletatoPlacebo-pre | Placebo-Post | Tetraselmis chuii-pre | Tetraselmis chuii-postRegno Unito
-
University of Kansas Medical CenterAttivo, non reclutanteRisonanza magnetica | Cognizione | Funzione fisica | Valutazione dell'assunzione dietetica | Pre-fragile | Anziani pre-fragiliStati Uniti
-
Thomas Jefferson UniversityCompletatoPre-ossigenazione
-
CooperVision International Limited (CVIL)Shanghai Eye Disease Prevention and Treatment CenterNon ancora reclutamento
-
Tianjin Medical University Eye HospitalNon ancora reclutamento
-
Penn State UniversityCompletato
-
Fenway Community HealthHarvard UniversityCompletatoProfilassi pre-esposizioneStati Uniti
-
University of FloridaNational Institutes of Health (NIH); National Institute on Aging (NIA)Completato
-
National University of SingaporeDanone Global Research & Innovation CenterReclutamento
-
NYU Langone HealthNational Institute on Aging (NIA)Reclutamento
Prove cliniche su Transcranial doppler ultrasound
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletatoMisurazione Doppler dell'arteria uterinaOlanda
-
Helse Nord-Trøndelag HFNorwegian University of Science and Technology; St. Olavs HospitalCompletatoIctus | Attacco ischemico transitorio | Attacco ischemico, transitorio | Incidente cerebrovascolare | Apoplessia cerebrovascolareNorvegia
-
Assiut UniversityNon ancora reclutamentoLassità vaginale
-
Duke UniversityPiedmont Orthopedic SocietyCompletatoLesioni della cuffia dei rotatori | Lacerazioni della cuffia dei rotatori | Protesi totale di spallaStati Uniti
-
Association Pro-arteAttivo, non reclutanteDebolezza, Muscolo | AmiotrofiaFrancia
-
Insel Gruppe AG, University Hospital BernReclutamentoMetastasi al cervelloSvizzera
-
Smart Alfa Teknoloji San. ve Tic. A.S.CompletatoImaging ad ultrasuoni delle strutture anatomicheStati Uniti
-
Aga Khan UniversityNon ancora reclutamento
-
Sarasota Memorial Health Care SystemIscrizione su invitoNodulo tiroideo | Noduli tiroideiStati Uniti
-
InSightecCompletatoTremore EssenzialeCanada, Stati Uniti, Giappone, Corea, Repubblica di