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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

32 week–37 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Etlik City Hospital

Ankara, Yenimahalle, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 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 outcomes

Evaluation of neonatal findings of the patients included in the study

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jan 22, 2024
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Enrolling by Invitation