NCT07676708

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
35mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jun 2029

First Submitted

Initial submission to the registry

June 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 22, 2026

Last Update Submit

June 27, 2026

Conditions

Outcome Measures

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.

    Day 1

Secondary Outcomes (4)

  • Cerebroplacental Ratio

    Day 1

  • Ductus Venosus Doppler

    Day 1

  • Uterine and Umbilical Artery Doppler

    Day 1

  • Isthmic Flow Index

    1 day

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Singleton pregnancy
  • Diagnosis of fetal growth restriction (estimated fetal weight \<10th percentile for gestational age)
  • Written informed consent obtained from the patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Growth RetardationPlacental Insufficiency

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsPlacenta Diseases

Central Study Contacts

Hanna Matt Louize, Specialist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obestetric and gynaecology specialist, Fetal and maternal ultrasound as subspecialty

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share