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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06215690
• Other study ID #: AESH-EK1-2023-066
• Status: Active, not recruiting
• Start date: May 15, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: April 2024
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Fetal growth restriction (FGR) affects up to 10% of all pregnancies. The International Society of Ultrasound in Obstetrics & Gynecology (ISUOG) adopts the Delphi consensus criteria for the definition of FGR. These criteria include estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd percentile or EFW or AC < 10th percentile with abnormal Doppler findings or decreased growth percentiles. FGR is a cause of perinatal morbidity and mortality. These perinatal outcomes include cardiovascular, endocrine and neurodevelopmental disorders. Fetal growth restriction, which is associated with lower neurobehavioral test scores, is associated with significant postnatal costs for both the health care system and families. Previous literature has shown that three-dimensional ultrasonography of intracranial structures reveals significant differences between fetuses with FGR and gestational age-appropriate (AGA) fetuses. However, the limited use of three-dimensional ultrasonography has hindered clinical applications. The frontal Anterior-Posterior Diameter (FAPD)/Occipital-Frontal Diameter (OFD) ratio has recently been used to assess frontal lobe development in fetuses with congenital heart disease. The FAPD is obtained by measuring from the inner line of the frontal bone along the fetal brain midline to the posterior edge of the CSP. This measurement refers to the frontal lobe of the fetal cerebrum. This study was designed to investigate the FAPD/ OFD ratio and frontal lobe development in fetuses with FGR and to evaluate cerebrovascular flow and anterior midbrain structures in FGR fetuses.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 25, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• Healthy hearts between the ages of 18-40

• Singleton pregnancies

• 32 to 37 weeks gestational week range

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Neurodevelopmental Disorders

Intervention

Diagnostic Test:
• Ultrasound measurements
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 Index (PI), Resistance Index (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

Locations

Country	Name	City	State
Turkey	Etlik City Hospital	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of neonatal findings of the patients included in the study	Fetuses included in the study will be evaluated after delivery.; Whether there is a need for Neonatal Intensive Care, APGAR scores, (0-10) Whether neonatal complications develop,; will be evaluated and compared in the control group and in the group with fetal growth retardation.	through study completion, an average of 4 months