跳至主要内容
临床试验/CTRI/2024/05/067080
CTRI/2024/05/067080尚未招募不适用

Assessment of variability in cortical development in late-onset IUGR fetuses using foetal MRI.

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年5月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
1
主要终点
1. Does intra-uterine growth restriction affect cortical development? Yes/ No

研究概览

简要总结

The study will enroll all clinically referred participants based on specific inclusion and exclusion criteria during the designated period. Demographic details in the form of age, hospital number, and period of gestation as per last USG would be recorded. Written informed consent will be taken from the patients and PCPNDT F form would be filled and signed by the radiologist and the patient.

Imaging process will be performed after 4 hours of fasting and without sedation, while the patient will be positioned in supine. Brain MRI will be taken at 3 different orthogonal planes. If motion artifact degradation is detected, the sequence will be repeated until a satisfactory image is obtained.

Following parameters will be measured and recorded:

Fissure depths- Biparietal diameter, Bilateral insular depths, bilateral cingulate fissure depths

Cortical thickness- Bilateral insula, temporal lobe, frontal lobe, occipital lobe, corpus callosum length Area-

Areas: Whole brain area, Cerebellum, Corpus callosum

The patient will be followed up till birth and following perinatal outcomes would be assessed at birth Gestational age at birth(weeks), birthweight (in grams), Neonatal acidosis, APGAR score at 5 mins, NICU stay length(days), Other perinatal complications. Radiological findings would be analyzed and statistically significant parameters would be put forth as neuro-imaging biomarkers for assessing cortical development in-utero. If any incidental pathology/defect is discovered in the foetus, findings will be communicated to the referring obstetrician to decide the further course of action.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Late onset IUGR Fetuses(greater than 32 weeks of gestational age) as per antenatal scan criteria
  • Appropriate for gestational age fetuses( greater than 32 weeks of gestational age) as per antenatal scan criteria.

排除标准

  • Motion artifacts during MRI acquisition
  • Incidentally diagnosed brain pathologies
  • Multiple Pregnancies
  • Chronic Maternal disease
  • Perinatal Infections.

结局指标

主要结局

1. Does intra-uterine growth restriction affect cortical development? Yes/ No

时间窗: Greater than 32 weeks of gestational age

2. Fetal MRI cortical development parameter(s) that showed significance and their recommended cutoffs

时间窗: Greater than 32 weeks of gestational age

次要结局

  • Perinatal outcome is affected in IUGR Foetuses:(Yes/No)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Akshat Rastogi

Kasturba Medical College, Manipal

研究点 (1)

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