Trials / Active Not Recruiting
Active Not RecruitingNCT06215690
Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- Ankara Etlik City Hospital · Other Government
- Sex
- All
- Age
- 32 Weeks – 37 Weeks
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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 |
Timeline
- Start date
- 2023-05-15
- Primary completion
- 2024-07-04
- Completion
- 2024-07-20
- First posted
- 2024-01-22
- Last updated
- 2024-07-08
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06215690. Inclusion in this directory is not an endorsement.