Fetal Growth RetardationNCT06215690
Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction
An observational study of Fetal Growth Retardation and Fetal Neurodevelopmental Disorder, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Fetal Neurodevelopmental Disorder
- What is being tested?
- Ultrasound measurements
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 20 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include normally developing fetuses between 32-37 weeks of gestation and fetuses with fetal growth restriction.
Who may be able to join
- Healthy hearts between the ages of 18-40
- Singleton pregnancies
- 32 to 37 weeks gestational week range
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06000
About this study
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.
Read the 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.
- Being tested
- Ultrasound measurements
- Keywords
- Fetal Growth Restriction, Anterior Middle Brain Structures, Cerebrovascular Flow
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women with Fetal Growth Restriction | Fetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation Receives: Diagnostic Test: Ultrasound measurements | |
| Healthy Pregnancies | Normally developing fetuses between 32-37 weeks of gestation Receives: Diagnostic Test: Ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation
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.
Measured: Prenatal (32-37 gestational weeks)
Secondary outcomes (1)
Evaluation of neonatal findings of the patients included in the study
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.
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 May 2023
- Primary completion4 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Can Ozan Ulusoy, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215690
- Sponsor's protocol ID
- AEŞH-EK1-2023-066
- Status last verified
- Jul 2024
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with hospital policy, it is not allowed to share data with third parties. If necessary, the chief researcher can be contacted
Publications
Ulusoy CO, Agaoglu RT, Sucu ST, Kurt DS, Bucak M, Seyhanli Z, Yucel KY. Evaluation of Anterior and Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction: A Prospective Study. J Clin Ultrasound. 2025 Feb;53(2):262-270. doi: 10.1002/jcu.23857. Epub 2024 Oct 8.
PubMed 39377442
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT06215690
- Acronym / sponsor ID
- AEŞH-EK1-2023-066
- Keywords
- Fetal Growth Restriction, Anterior Middle Brain Structures, Cerebrovascular Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 May 2023 (actual)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women with Fetal Growth Restriction | – | Diagnostic Test: Ultrasound measurementsFetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation |
| Healthy Pregnancies | – | Diagnostic Test: Ultrasound measurementsNormally developing fetuses between 32-37 weeks of gestation |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include normally developing fetuses between 32-37 weeks of gestation and fetuses with fetal growth restriction.
Key inclusion criteria (3 listed)
- Healthy hearts between the ages of 18-40
- Singleton pregnancies
- 32 to 37 weeks gestational week range
Key exclusion criteria (6 listed)
- Multiple pregnancies
- Fetuses with fetal karyotype abnormalities
- Pregnant women with co-morbidity
- Fetuses with fetal intracranial hemorrhage
- Fetuses with cranial anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound measurementsEvaluation 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 | Diagnostic test | Healthy Pregnancies, Pregnant Women with Fetal Growth Restriction |
Primary outcome
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.
1 secondary outcome
Evaluation of neonatal findings of the patients included in the study
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 39377442Ulusoy CO, Agaoglu RT, Sucu ST, Kurt DS, Bucak M, Seyhanli Z, Yucel KY. Evaluation of Anterior and Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction: A Prospective Study. J Clin Ultrasound. 2025 Feb;53(2):262-270. doi: 10.1002/jcu.23857. Epub 2024 Oct 8.
- Individual participant dataSharing planned: No. In accordance with hospital policy, it is not allowed to share data with third parties. If necessary, the chief researcher can be contacted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation and Fetal Neurodevelopmental Disorder, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation (time frame: Prenatal (32-37 gestational weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06215690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.