Evaluation of Brain Volume and Dimensions in Healthy Fetuses Using Obstetrics Ultrasound Examination at 14-34 Weeks of Pregnancy.

The aim of this study is to evaluate the "normal" development of cerebral cortex with quantitative measurement in low risk pregnant women

Study Overview

• Status: Unknown
• Conditions: Normal Fetal Brain Morphology
• Intervention / Treatment: Diagnostic test: ultrasonographic scan of fetal brain

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:

1. Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1).
2. 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).
3. 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).
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).
5. 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 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Eyal Zohav, M.D; Phone Number: +972544789782; Email: eyalzohav@hotmail.com
• Study Contact Backup: Name: Shaton Ben Rubi, S.C; Phone Number: +972522750328; Email: sharonbenr@tlv.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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.

Exclusion Criteria:

• rupture of membranes, severe pre-eclampsia, HELLP syndrome (Hemolysis, elevated liver enzymes, and low platelet count), Twins

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: ultrasonographic scan of fetal brain; 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	the time required for detailed prenatal ultrasound scan (approximately 60 minute)

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Publications and helpful links

General 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.
• Filly 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.
• Malinger 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.
• Egana-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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2017
• Primary Completion (Anticipated): June 20, 2019
• Study Completion (Anticipated): June 20, 2020

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound; normogram; brain lumination; fetal cortex
• Other Study ID Numbers: 0564-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No