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

July 4, 2024 updated by: Can Ozan Ulusoy, Ankara Etlik City Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06000
        • Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pregnant Women with Fetal Growth Restriction
Fetuses with fetal growth restriction according to Delphi consensus criteria between 32-37 weeks of gestation
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
Healthy Pregnancies
Normally developing fetuses between 32-37 weeks of gestation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Prenatal (32-37 gestational weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of neonatal findings of the patients included in the study
Time Frame: through study completion, an average of 4 months

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.
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEŞH-EK1-2023-066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In accordance with hospital policy, it is not allowed to share data with third parties. If necessary, the chief researcher can be contacted

IPD Sharing Time Frame

2 month

IPD Sharing Access Criteria

Data of patients diagnosed with FGR between 32- 37 weeks and patients without FGR between 32-37 weeks will be shared.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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