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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
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Normal Fetal Brain Morphology 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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
  1. 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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Eyal Zohav, M.D +972544789782 eyalzohav@hotmail.com
Contact: Shaton Ben Rubi, S.C +972522750328 sharonbenr@tlv.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Publications:
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03186807     History of Changes
Other Study ID Numbers: 0564-16
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tel-Aviv Sourasky Medical Center:
normogram
brain lumination
fetal cortex
ultrasound