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临床试验/CTRI/2015/01/005401
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Fetal biometry reference charts for North Indian Population

Apollo Centre for Fetal Medicine1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2007年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,000
试验地点
1
主要终点
Fetal Biometry reference charts for North Indian population

研究概览

简要总结

Fetal biometry is an integral part of obstetric management starting form accurate estimation of the gestational age in the first trimester to assessment as well as monitoring of fetal growth later in pregnancy. It is long recognised that these measurements are specific to different populations and the best charts for a particular ethnicity should be based on ‘nomograms’ established for that population. This study was undertaken to establish reference ranges for fetal biometry for healthy Indian women. This retrospective observation study includes all low risk pregnant women who attended the Fetal Medicine clinic from January 2007 to January 2013 for routine obstetric ultrasounds and went on to deliver a healthy newborn at or after 37 weeks. The number of ultrasound examinations were limited to three per fetus. All women signed an informed consent for the study. Care was taken during data collection to strictly maintain the confidentiality of all participants . The 5th, 10th, 50th, 90th and 95th centiles for each growth parameter (biparietal diameter, head circumference, abdominal circumference and femur length) was calculated for each gestational week from 16 to 40 weeks and plotted to make nomograms.

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

  • Low risk women with singleton pregnancy
  • Confirmed gestation
  • Gestation between 16 weeks + 0 days to 40 weeks + 0 days.

排除标准

  • Multiple pregnancy
  • Unsure gestation
  • Pre-existing medical disorders
  • Obstetric complications like gestational hypertension, gestational diabetes, preterm delivery
  • Fetal abnormality
  • Abnormal result of invasive testing.

结局指标

主要结局

Fetal Biometry reference charts for North Indian population

时间窗: 31st Decemeber, 2013

次要结局

  • Nomograms for fetal growth parameters for North Indian low risk women(6 years)

研究者

发起方
Apollo Centre for Fetal Medicine
申办方类型
Private hospital/clinic

研究点 (1)

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