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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-20

Study Completion Date

2020-06-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Normal Fetal Brain Morphology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ultrasonographic scan of fetal brain

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.