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Not yet recruitingNCT07676708Updated Jun 30, 2026

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 .

An observational study in Fetal Growth Restriction, Placental Insufficiency and Aortic Isthmus Doppler, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Fetal Growth Restriction
  • Placental Insufficiency
  • Aortic Isthmus Doppler
  • Cerebroplacental Ratio
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Singleton pregnant women attending the fetal medicine unit at Women's Health Hospital, Assiut University, including both fetal growth restriction cases and normal controls.

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

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

  • 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.

05

What researchers measure

Primary outcomes

  1. Aortic Isthmus Pulsatility Index

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

    Time frame: Day 1

Secondary outcomes

  1. Cerebroplacental Ratio

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

    Time frame: Day 1

  2. Ductus Venosus Doppler

    Assessment of ductus venosus pulsatility index and its relationship with aortic isthmus Doppler changes in fetal growth restriction.

    Time frame: Day 1

  3. Uterine and Umbilical Artery Doppler

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

    Time frame: Day 1

  4. Isthmic Flow Index

    Assessment of isthmic flow index (IFI) and its association with fetal hemodynamic changes in fetal growth restriction cases.

    Time frame: 1 day

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07676708
Lead sponsor
Assiut University
Responsible party
Hanna Matta louize (Obestetric and gynaecology specialist, Fetal and maternal ultrasound as subspecialty, Assiut University) — Principal investigator
First posted
Jun 30, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Jun 30, 2026

Study contacts

Hanna Matt Louize, Specialist
Contact
hanna.matta0155@med.aun.edu.eg
+201287618565

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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