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

Active, not recruiting

• Conditions: Fetal Neurodevelopmental Disorder; Fetal Growth Retardation
• Interventions: Diagnostic Test: Ultrasound measurements

• Registration Number: NCT06215690
• Lead Sponsor: Ankara Etlik City Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-22
• Status Verified: 2024-07
• Primary Completion: 2024-07-04
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Pregnancies	Ultrasound measurements	Normally developing fetuses between 32-37 weeks of gestation
Pregnant Women with Fetal Growth Restriction	Ultrasound measurements	Fetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation

Primary Outcome Measures

Name	Time	Method
Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation	Prenatal (32-37 gestational weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of neonatal findings of the patients included in the study	through study completion, an average of 4 months	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.

Trial Locations

Locations (1)

Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey