- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676708
Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction , and the Changes in Aortic Isthmus Doppler Parameters With Every Changes of Other Early Iugr Parameters Like EFW, Uterine Artery Doppler, Cerebroplacental Ratio and Ductus Venosus Doppler in Comparison With Normal Group .
Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction, Cross Sectional Comparative Study
This study aims to evaluate the patterns of aortic isthmus Doppler in fetuses diagnosed with early fetal growth restriction (FGR) and to correlate these findings with the severity of FGR and other Doppler parameters.
A cross-sectional comparative observational study will be conducted on singleton pregnant women attending the fetal medicine unit at Assiut University Hospital. Participants will be divided into two groups: fetuses with FGR and normal controls.
Doppler measurements including aortic isthmus indices, uterine artery, umbilical artery, middle cerebral artery, cerebroplacental ratio, and ductus venosus will be assessed at a single time point. The study will help to clarify the clinical value of aortic isthmus Doppler in early detection and assessment of fetal compromise in FGR cases.
Study Overview
Status
Detailed Description
Fetal growth restriction (FGR) is a major contributor to perinatal morbidity and mortality and is commonly associated with placental insufficiency. Early identification of fetal compromise remains a significant clinical challenge. Doppler assessment of fetal circulation has been widely used to monitor affected fetuses, including evaluation of the umbilical artery, middle cerebral artery, and ductus venosus.
The aortic isthmus represents a critical vascular junction reflecting the balance between cerebral and placental circulation. Changes in aortic isthmus Doppler patterns may provide early insights into fetal hemodynamic adaptation and deterioration in cases of FGR.
This cross-sectional comparative observational study will be conducted at the fetal medicine unit, Women's Health Hospital, Assiut University. The study population will include singleton pregnancies diagnosed with FGR (EFW <10th percentile) and a control group of normal fetuses.
Participants will undergo a single-time Doppler assessment including fetal biometry, uterine artery PI, umbilical artery PI, middle cerebral artery PI, cerebroplacental ratio, ductus venosus PI, and aortic isthmus Doppler indices. The aortic isthmus flow will be classified based on the isthmic flow index (IFI) into five categories, reflecting progressive hemodynamic changes.
The primary objective is to determine the correlation between aortic isthmus Doppler changes and the severity of FGR based on estimated fetal weight percentiles. Secondary objectives include correlation of aortic isthmus findings with cerebroplacental ratio and ductus venosus parameters.
This study is designed as a pilot exploratory study due to limited previous data. Results are expected to enhance understanding of fetal hemodynamics and potentially improve monitoring strategies in pregnancies complicated by FGR.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hanna Matt Louize, Specialist
- Phone Number: +201287618565
- Email: hanna.matta0155@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Singleton pregnancy
- Diagnosis of fetal growth restriction (estimated fetal weight <10th percentile for gestational age)
- Written informed consent obtained from the patient
Exclusion Criteria:
- Major fetal structural anomalies, especially cardiovascular anomalies
- Multiple pregnancy (e.g., twins)
- Suspected chromosomal abnormalities or genetic syndromes
- Severe maternal comorbidities affecting Doppler results (e.g., uncontrolled diabetes, lupus)
- Uncertain gestational age
- Fetal demise before Doppler assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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FGR Group
Singleton pregnancies diagnosed with fetal growth restriction (estimated fetal weight less than the 10th percentile for gestational age), undergoing Doppler assessment including aortic isthmus and other fetal vessels.
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Control Group
Singleton pregnancies with normal fetal growth (estimated fetal weight above the 10th percentile), undergoing the same Doppler assessment as the FGR group for comparison.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Aortic Isthmus Pulsatility Index
Time Frame: Day 1
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Measurement of the aortic isthmus pulsatility index (PI) and its correlation with the severity of fetal growth restriction based on estimated fetal weight percentiles.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebroplacental Ratio
Time Frame: Day 1
|
Measurement of cerebroplacental ratio (MCA PI / UA PI) and its correlation with aortic isthmus Doppler findings.
|
Day 1
|
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Ductus Venosus Doppler
Time Frame: Day 1
|
Assessment of ductus venosus pulsatility index and its relationship with aortic isthmus Doppler changes in fetal growth restriction.
|
Day 1
|
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Uterine and Umbilical Artery Doppler
Time Frame: Day 1
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Evaluation of uterine artery and umbilical artery pulsatility indices and their association with aortic isthmus Doppler parameters.
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Day 1
|
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Isthmic Flow Index
Time Frame: 1 day
|
Assessment of isthmic flow index (IFI) and its association with fetal hemodynamic changes in fetal growth restriction cases.
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1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Fetal Diseases
- Growth Disorders
- Placenta Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Fetal Growth Retardation
- Placental Insufficiency
Other Study ID Numbers
- HannaMSc-E-iugr-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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