Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction

NCT06215690 | Active Not Recruiting

• 1 other identifier: AEŞH-EK1-2023-066
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted to examine the effects of abnormal growth pattern and cerebrovascular blood flow measurements on fetal frontal lobe development with the advancing ultrasound technology. Antenatal assessment of frontal lobe development will enable clinicians to predict neurodevelopmental problems that may develop postnatally. In addition, this study will examine the effects of FGR on frontal lobe development.

Conditions

Fetal Growth Retardation; Fetal Neurodevelopmental Disorder

Keywords

Fetal Growth Restriction; Anterior Middle Brain Structures; Cerebrovascular Flow

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation

  Demographic data, ultrasonographically obtained biometric measurements, and Doppler flow data will be compared in both groups. * Frontal Anterior Posterior Length, Occipital to Frontal Diameter ratio mm/mm (FAPD mm/OFD mm) * Cerebellar length, head circumference length ratio mm/mm (CD mm / HC mm) The main biometric measurement of the study will be comparison. The percentile values of the Anterior Cerebral Artery Doppler Pulsatility Index (cm/s) (ACA PI cm/s ) and Middle Cerebral Artery Doppler Pulsatility Index cm/s (MCA PI cm/s) will be calculated for the week of ultrasonographic measurement, and the ratio of ACA PI and MCA PI will be compared in fetuses with and without fetal growth retardation.

  Prenatal (32-37 gestational weeks)

Secondary Outcomes (1)

• Evaluation of neonatal findings of the patients included in the study

  through study completion, an average of 4 months

Study Arms (2)

Pregnant Women with Fetal Growth Restriction

Fetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation

Diagnostic Test: Ultrasound measurements

Healthy Pregnancies

Normally developing fetuses between 32-37 weeks of gestation

Diagnostic Test: Ultrasound measurements

Interventions

Ultrasound measurements DIAGNOSTIC_TEST

Evaluation will be performed by ultrasonography. The following measurements will be taken with the ultrasonographic examination. * BPD (Biparietal Diameter) * HC (Head Circumference) * AC (Abdominal Circumference) * FL (Femur Length) * EFW (Estimated Fetal Weight) * Umbilical Artery Doppler Sistole/Diastole (S/D) ,Pulsatility İndex (PI), Resistance İndex (RI) * Middle Cerebral Artery S/D,PI,RI * Uterine Artery Doppler PI * Anterior Cerebral Artery S/D,PI,RI * CPUR (Cerebral - Placental - Uterin PI Ratio) * CPR (Cerebral - Placental PI Ratio) * The deepest free single vertical pocket in the amnion mai * Cavum Septum Pellucidum: Width - Length Diameters * OFD (Occipitofrontal length) * FAPD (Frontal Anterior Posterior Diameter) * FAPD/OFD ratio * Cerebellar diameter * Lateral ventricle depth * Insular depth * Sylvian fissure depth

Healthy Pregnancies; Pregnant Women with Fetal Growth Restriction

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study will include normally developing fetuses between 32-37 weeks of gestation and fetuses with fetal growth restriction.

You may qualify if:

• Healthy hearts between the ages of 18-40
• Singleton pregnancies
• to 37 weeks gestational week range

You may not qualify if:

• Multiple pregnancies
• Fetuses with fetal karyotype abnormalities
• Pregnant women with co-morbidity
• Fetuses with fetal intracranial hemorrhage
• Fetuses with cranial anomalies
• Maternal obesity preventing measurement

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06000, Turkey (Türkiye)

Location

Related Publications (1)

• Ulusoy CO, Agaoglu RT, Sucu ST, Kurt DS, Bucak M, Seyhanli Z, Yucel KY. Evaluation of Anterior and Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction: A Prospective Study. J Clin Ultrasound. 2025 Feb;53(2):262-270. doi: 10.1002/jcu.23857. Epub 2024 Oct 8.

  PMID: 39377442 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 22, 2024
• Study Start: May 15, 2023
• Primary Completion: July 4, 2024
• Study Completion: July 20, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)