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

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

Sponsors

Lead sponsor: Tel-Aviv Sourasky Medical Center

Source Tel-Aviv Sourasky Medical Center
Brief Summary

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:

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.

Overall Status Not yet recruiting
Start Date June 20, 2017
Completion Date June 20, 2020
Primary Completion Date June 20, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Cerebral cortex thickness and volume stratified by gestational age the time required for detailed prenatal ultrasound scan (approximately 60 minute)
Enrollment 500
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: ultrasonographic scan of fetal brain

Description: 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.

Arm group label: low risk pregnancy

Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: Female

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Eyal Zohav, M.D

Phone: +972544789782

Email: [email protected]

Verification Date

June 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Arm group label: low risk pregnancy

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.and low risk for fetal brain developmental disorders.

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov