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临床试验/NCT03898440
NCT03898440已完成不适用

Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
318
试验地点
1
主要终点
fetal anogenital distance

研究概览

简要总结

The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date.

The study also evaluates the feasibility of the measure and its interobserver variability.

详细描述

The anogenital distance of female newborns is shorter than that of male newborns.

Urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance.

Anogenital distance is a good marker of fetal exposure to androgenic substances.

Prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis).

Is the anogenital distance easy to make measure? Can this procedure be reproduced? What are the threshold values to determine fetal sex at each term of pregnancy?

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant woman
  • sonographic fetal follow up in Brest Hospital
  • term>18 weeks of gestation

排除标准

  • No datation between 11 weeks of gestation and 13 weeks of gestation and 6 days by crown-rump length measurement
  • no consent
  • ultrasound performed by an operator without ultrasonography graduation

结局指标

主要结局

fetal anogenital distance

时间窗: During fetal ultrasound exam

The distance will be measured from the center of the anus to the posterior convergence of the fourchette in female fetuses and to the posterior base of the scrotum in male fetuses

次要结局

  • Estimated fetal weight(During fetal ultrasound exam)
  • Ano-genital distance in mm(During fetal ultrasound exam)
  • Interobserver variability(During fetal ultrasound exam)
  • neonatal sex determination(During fetal ultrasound exam)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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