Normal Fetal Brain MorphologyNCT03186807
Evaluation of Brain Volume and Dimensions in Healthy Fetuses Using Obstetrics Ultrasound Examination at 14-34 Weeks of Pregnancy.
An observational study of Normal Fetal Brain Morphology, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The aim of this study is to evaluate the "normal" development of cerebral cortex with quantitative measurement in low risk pregnant women Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Fetal Brain Morphology
- What is being tested?
- ultrasonographic scan of fetal brain
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2017to 20 Jun 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent.
Who may be able to join
- Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent.
- Gestation who had a singleton fetus in cephalic presentation, with well documented gestational age by first trimester US scan CRL.
- Biometric measurement within 10th to 90th percentile.
Who cannot join
- rupture of membranes, severe pre-eclampsia, HELLP syndrome (Hemolysis, elevated liver enzymes, and low platelet count), Twins
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate the "normal" development of cerebral cortex with quantitative measurement in low risk pregnant women
Read the detailed description
Study design:
This is a prospective study that evaluates normal fetal brain cortex development from 14 to 34 WG using 2D and 3D ultrasound in singleton low risk pregnancies with unknown obstetrical complications. The clinical and obstetrical data will be obtained prior to the US evaluation; and will include maternal medical and obstetrical data and confirmation of fetal gestational age based on first day of the last menstrual cycle (LMP) supported by well documented CRL from first trimester US. Brain biometric and sulcation analysis includes:
- Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1).
- Parietoccipital fissures will be measured in an axial slice above the transthalamic plane used for the BPD assessment tracing a perpendicular line from the longitudinal fissure to the apex of the parietoccipital fissures (4).
- Insular depths will be measured in the axial slice located immediately below the anterior commissure and the cavum septum pellucidum, tracing a perpendicular line from the median longitudinal fissure to the most external border of the insular cortex(4).
- Lateral fissure depths will be measured in the same plane described above, with a continuing line starting from the most external border of the insular cortex to the interface conformed between the subarachnoid space and the skull(4).
- Cingulate fissures will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissures.
- Calcarine fissures will be measured in the coronal transcerebellar plane as described in ISOUG, tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissures.
Two measurements will be taken by two examiners in order to evaluate intraobserver and interobserver reproducibility.
In all the cases a maximum effort will be undertake to obtain adequate volumes of the brain in order to enable offline evaluation of the different structures.
- Conditions
- Normal Fetal Brain Morphology
- Being tested
- ultrasonographic scan of fetal brain
- Keywords
- normogram, brain lumination, fetal cortex, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic scan of fetal brainDiagnostic test
- Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1). specific measurements as follow:
- Parietoccipital fissures will be measured from the most external border of cortex to the luminar line.
- Lateral fissure depths will be measured from the most external border of the insular cortex to the interface confirmed between the subarachnoid space and the skull.
- Cingulate fissures will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissures.
- Calcarine fissures will be measured in the coronal transcerebellar plane as tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissures.
| Study group | Role | What they receive |
|---|---|---|
| low risk pregnancy | Inclusion criteria - Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent.
Gestation who had a singleton fetus in cephalic presentation, with well documented gestational age by first trimester US scan CRL.
Biometric measurement within 10th to 90th percentile.and low risk for fetal brain developmental disorders. Receives: Diagnostic Test: ultrasonographic scan of fetal brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral cortex thickness and volume stratified by gestational age
ultrasonographic measurements of fetal cerebral cortex thickness and volume at different gestational age (W/G) (14 W/G - 34 W/G). in order to create normogram and reference values.
Measured: the time required for detailed prenatal ultrasound scan (approximately 60 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jun 2017 (estimated)
- Primary completion20 Jun 2019 (estimated)
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Normal Fetal Brain MorphologyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186807
- Sponsor's protocol ID
- 0564-16
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a prospective study that evaluates normal fetal brain cortex development from 14 to 34 WG using 2D and 3D ultrasound in singleton low risk pregnancies with unknown obstetrical complications. Recruitment at time of visit to our hospital emergency room, outpatient clinic, and hospitalized patient. Each participating women can take part in a single Ultrasonographical scan related to our study objective. The clinical and obstetrical data will be obtained prior to the US evaluation; and will include maternal medical and obstetrical data and confirmation of fetal gestational age based on first day of the last menstrual cycle (LMP) supported by CRL
Publications
Sonographic examination of the fetal central nervous system: guidelines for performing the 'basic examination' and the 'fetal neurosonogram'. Ultrasound Obstet Gynecol. 2007 Jan;29(1):109-116. doi: 10.1002/uog.3909. No abstract available.
PubMed 17200992Filly RA, Cardoza JD, Goldstein RB, Barkovich AJ. Detection of fetal central nervous system anomalies: a practical level of effort for a routine sonogram. Radiology. 1989 Aug;172(2):403-8. doi: 10.1148/radiology.172.2.2664864.
PubMed 2664864Malinger G, Lerman-Sagie T, Watemberg N, Rotmensch S, Lev D, Glezerman M. A normal second-trimester ultrasound does not exclude intracranial structural pathology. Ultrasound Obstet Gynecol. 2002 Jul;20(1):51-6. doi: 10.1046/j.1469-0705.2002.00743.x.
PubMed 12100418Egana-Ugrinovic G, Sanz-Cortes M, Figueras F, Bargallo N, Gratacos E. Differences in cortical development assessed by fetal MRI in late-onset intrauterine growth restriction. Am J Obstet Gynecol. 2013 Aug;209(2):126.e1-8. doi: 10.1016/j.ajog.2013.04.008. Epub 2013 Apr 9.
PubMed 23583839
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Volume and Dimensions in Healthy Fetuses Using Obstetrics Ultrasound Examination at 14-34 Weeks of Pregnancy.
- ClinicalTrials.gov ID
- NCT03186807
- Acronym / sponsor ID
- 0564-16
- Conditions
- Normal Fetal Brain Morphology
- Keywords
- normogram, brain lumination, fetal cortex, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 20 Jun 2017 (estimated)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 14 Jun 2017 (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 aim of this study is to evaluate the "normal" development of cerebral cortex with quantitative measurement in low risk pregnant women
Detailed description
Study design:
This is a prospective study that evaluates normal fetal brain cortex development from 14 to 34 WG using 2D and 3D ultrasound in singleton low risk pregnancies with unknown obstetrical complications. The clinical and obstetrical data will be obtained prior to the US evaluation; and will include maternal medical and obstetrical data and confirmation of fetal gestational age based on first day of the last menstrual cycle (LMP) supported by well documented CRL from first trimester US. Brain biometric and sulcation analysis includes:
- Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1).
- Parietoccipital fissures will be measured in an axial slice above the transthalamic plane used for the BPD assessment tracing a perpendicular line from the longitudinal fissure to the apex of the parietoccipital fissures (4).
- Insular depths will be measured in the axial slice located immediately below the anterior commissure and the cavum septum pellucidum, tracing a perpendicular line from the median longitudinal fissure to the most external border of the insular cortex(4).
- Lateral fissure depths will be measured in the same plane described above, with a continuing line starting from the most external border of the insular cortex to the interface conformed between the subarachnoid space and the skull(4).
- Cingulate fissures will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissures.
- Calcarine fissures will be measured in the coronal transcerebellar plane as described in ISOUG, tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissures.
Two measurements will be taken by two examiners in order to evaluate intraobserver and interobserver reproducibility.
In all the cases a maximum effort will be undertake to obtain adequate volumes of the brain in order to enable offline evaluation of the different structures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low risk pregnancy | – | Diagnostic Test: ultrasonographic scan of fetal brainInclusion criteria - Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent. Gestation who had a singleton fetus in cephalic presentation, with well documented gestational age by first trimester US scan CRL. Biometric measurement within 10th to 90th percentile.and low risk for fetal brain developmental disorders. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent.
Key inclusion criteria (3 listed)
- Women aged 18-45 years old ,Pregnant women between 14+0 and 34+0 weeks.speaking Hebrew language and eligible for obtaining informed consent.
- Gestation who had a singleton fetus in cephalic presentation, with well documented gestational age by first trimester US scan CRL.
- Biometric measurement within 10th to 90th percentile.
Key exclusion criteria (1 listed)
- rupture of membranes, severe pre-eclampsia, HELLP syndrome (Hemolysis, elevated liver enzymes, and low platelet count), Twins
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 |
|---|---|---|
| ultrasonographic scan of fetal brain1. Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1). specific measurements as follow: 2. Parietoccipital fissures will be measured from the most external border of cortex to the luminar line. 3. Lateral fissure depths will be measured from the most external border of the insular cortex to the interface confirmed between the subarachnoid space and the skull. 4. Cingulate fissures will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissures. 6. Calcarine fissures will be measured in the coronal transcerebellar plane as tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissures. | Diagnostic test | low risk pregnancy |
Primary outcome
Cerebral cortex thickness and volume stratified by gestational age
Time frame: the time required for detailed prenatal ultrasound scan (approximately 60 minute)
ultrasonographic measurements of fetal cerebral cortex thickness and volume at different gestational age (W/G) (14 W/G - 34 W/G). in order to create normogram and reference values.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 17200992Sonographic examination of the fetal central nervous system: guidelines for performing the 'basic examination' and the 'fetal neurosonogram'. Ultrasound Obstet Gynecol. 2007 Jan;29(1):109-116. doi: 10.1002/uog.3909. No abstract available.
- Background: PubMed 2664864Filly RA, Cardoza JD, Goldstein RB, Barkovich AJ. Detection of fetal central nervous system anomalies: a practical level of effort for a routine sonogram. Radiology. 1989 Aug;172(2):403-8. doi: 10.1148/radiology.172.2.2664864.
- Background: PubMed 12100418Malinger G, Lerman-Sagie T, Watemberg N, Rotmensch S, Lev D, Glezerman M. A normal second-trimester ultrasound does not exclude intracranial structural pathology. Ultrasound Obstet Gynecol. 2002 Jul;20(1):51-6. doi: 10.1046/j.1469-0705.2002.00743.x.
- Background: PubMed 23583839Egana-Ugrinovic G, Sanz-Cortes M, Figueras F, Bargallo N, Gratacos E. Differences in cortical development assessed by fetal MRI in late-onset intrauterine growth restriction. Am J Obstet Gynecol. 2013 Aug;209(2):126.e1-8. doi: 10.1016/j.ajog.2013.04.008. Epub 2013 Apr 9.
- Individual participant dataSharing planned: No. This is a prospective study that evaluates normal fetal brain cortex development from 14 to 34 WG using 2D and 3D ultrasound in singleton low risk pregnancies with unknown obstetrical complications. Recruitment at time of visit to our hospital emergency room, outpatient clinic, and hospitalized patient. Each participating women can take part in a single Ultrasonographical scan related to our study objective. The clinical and obstetrical data will be obtained prior to the US evaluation; and will include maternal medical and obstetrical data and confirmation of fetal gestational age based on first day of the last menstrual cycle (LMP) supported by CRL
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Fetal Brain Morphology, run by Tel-Aviv Sourasky Medical Center.
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 1 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eyal Zohav, M.D (+972544789782, eyalzohav@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral cortex thickness and volume stratified by gestational age (time frame: the time required for detailed prenatal ultrasound scan (approximately 60 minute)). 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 NCT03186807, which also lists 4 linked publications.
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 14 Jun 2017.