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NCT Number: 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 .

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Aortic Isthmus Pulsatility Index

    Time frame: Day 1

    Measurement of the aortic isthmus pulsatility index (PI) and its correlation with the severity of fetal growth restriction based on estimated fetal weight percentiles.

Secondary outcomes

  1. Cerebroplacental Ratio

    Time frame: Day 1

    Measurement of cerebroplacental ratio (MCA PI / UA PI) and its correlation with aortic isthmus Doppler findings.

  2. 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.

  3. Uterine and Umbilical Artery Doppler

    Time frame: Day 1

    Evaluation of uterine artery and umbilical artery pulsatility indices and their association with aortic isthmus Doppler parameters.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Matt Louize, Specialist

CONTACT

[email protected]

+201287618565

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction, Cross Sectional Comparative Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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