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临床试验/CTRI/2023/07/055578
CTRI/2023/07/055578尚未招募不适用

Comparison of fetal growth by WHO and Intergrowth-21 growth charts for Indian Population

Dr Sangeeta Gupta1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Percentage of fetuses falling under various centiles

研究概览

简要总结

This is a prospective observational study comparing the growth centiles between WHO and INTERGROWTH 21 fetal growth charts and correlating it with INTERGROWTH 21 neonatal birthweight centiles.

The primary outcome will be the percentage of fetuses falling under various centiles (below 10th centile, between 10th and 90th centile and above 90th centile) in fetal growth charts by WHO and INTERGROWTH 21 growth charts at gestational ages (30 to 32weeks and 36 to 38 weeks) respectively and compare the results in each group of centiles and the difference in fetal weight and birthweight by two charts and proportion with  more than 10 percentage difference.

The secondary outcome will be perinatal outcomes (5 min Apgar less than 7, neonatal intensive care unit admission and neonatal death) in the three categories i.e below 10th centile, between 10th and 90th centile and above 90th centile.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant females with Singleton pregnancy Age more than 18 years Body-mass index (BMI)greater than 18 kg per m2 and less than 30kg per m2) Gestational age more than 28 weeks (where dating by ultrasonography before 16 weeks is available) Anomaly scan at 18-22 weeks with full morphological and biometric evaluation No evidence in the present pregnancy of congenital disease or fetal anomaly.

排除标准

  • History of recurrent miscarriages Previous FGR History of smoking cigarettes in the past six months Used illicit drugs in the past year.

结局指标

主要结局

Percentage of fetuses falling under various centiles

时间窗: Pregnant women at gestational age between 30 to 32 weeks & 36 to 38 weeks respectively

below ten centile

时间窗: Pregnant women at gestational age between 30 to 32 weeks & 36 to 38 weeks respectively

between ten & ninety centile and above ninety centile in fetal growth charts by WHO and INTERGROWTH 21 growth charts at gestational ages 30 to 32 weeks and 36 to 38 weeks respectively and compare the results in each group of centiles

时间窗: Pregnant women at gestational age between 30 to 32 weeks & 36 to 38 weeks respectively

Difference in fetal weight and birthweight by two charts and proportion with greater than 10 percentage difference

时间窗: Pregnant women at gestational age between 30 to 32 weeks & 36 to 38 weeks respectively

次要结局

  • Perinatal outcomes(5 min Apgar less than 7 Neonatal intensive care unit admissions & neonatal death in the three categories)

研究者

发起方
Dr Sangeeta Gupta
申办方类型
Other [self]

研究点 (1)

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