Clinical trial NCT06215690: Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction
Official title: Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fetal Growth Retardation
Fetal Neurodevelopmental Disorder
Keywords: Fetal Growth Restriction
Anterior Middle Brain Structures
Cerebrovascular Flow
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation
timeFrame: Prenatal (32-37 gestational weeks)
Secondary outcomes:
measure: Evaluation of neonatal findings of the patients included in the study
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
state: Yenimahalle
Study officials:
References: