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

A

Ankara Etlik City Hospital

Status

Active, not recruiting

Conditions

Fetal Growth Retardation
Fetal Neurodevelopmental Disorder

Treatments

Diagnostic Test: Ultrasound measurements

Study type

Observational

Funder types

Other

Identifiers

NCT06215690
AEŞH-EK1-2023-066

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

32 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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