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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-07-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fetal Growth Retardation Fetal Neurodevelopmental Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women with Fetal Growth Restriction

Fetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation

Ultrasound measurements

Intervention Type 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

Healthy Pregnancies

Normally developing fetuses between 32-37 weeks of gestation

Ultrasound measurements

Intervention Type 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

Interventions

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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 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes