Evaluation of Brain Volume and Dimensions in Healthy Fetuses Using Obstetrics Ultrasound Examination at 14-34 Weeks of Pregnancy.
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|ClinicalTrials.gov Identifier: NCT03186807|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment|
|Normal Fetal Brain Morphology||Diagnostic Test: ultrasonographic scan of fetal brain|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Evaluation of Brain Volume and Dimensions in Healthy Fetuses Using Obstetrics Ultrasound Examination at 14-34 Weeks of Pregnancy.|
|Estimated Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||June 20, 2019|
|Estimated Study Completion Date :||June 20, 2020|
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
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186807
|Contact: Eyal Zohav, M.Demail@example.com|
|Contact: Shaton Ben Rubi, S.Cfirstname.lastname@example.org|