跳至主要内容
临床试验/NCT03186807
NCT03186807Unknown不适用

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

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 500 人开始时间: 2017年6月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
Cerebral cortex thickness and volume stratified by gestational age

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Cerebral cortex thickness and volume stratified by gestational age

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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