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临床试验/NCT02805491
NCT02805491已完成不适用

Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

Centre Hospitalier Universitaire, Amiens11 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2011年3月3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
197
试验地点
11
主要终点
presence of hypospadia

研究概览

简要总结

We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .

详细描述

Hypospadias is the most frequent malformation of the external genital organs in the male infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and an incompletely formed foreskin. The condition is generally isolated and the aetiology is unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors (which are probably interlinked).

A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable role of environment factors: in fact, certain exogenous compounds (collectively referred to as "endocrine disruptors" (EDs)) may modify hormonal functions and thus exert harmful effects on the organism or its offspring.

The male urethra develops between the 8th and 16th weeks of gestation in an androgen-dependence manner. In utero exposure of the foetus to EDs may have a physiopathological role in the abnormal development of the male genital bud and thus in the development of hypospadia. These EDs are present in many different substances, such as pesticides.

Many epidemiological studies have evidenced an increase in the incidence of hypospadias in children born to exposed parents. Furthermore, animal studies have identified a certain number of compounds associated with hypospadias after in utero exposure. However, human foetal samples have very rarely been assayed in an attempt to measure the true level of impregnation (i.e. the dose received). At present, it is not possible to draw firm conclusions with regard to the true extent of a link between EDs and the increased incidence of hypospadia.

The "HypoMeco" project is a prospective case-control study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 1 Day(Child)
性别
Male
接受健康志愿者

入选标准

  • male newborns
  • born after February 1st, 2011, in a maternity hospital/clinic in the Picardie region

排除标准

  • refusal to participate,
  • severe associated disorders
  • associated multiple malformation syndromes
  • patients not attending the consultation.
  • parents under the age of 18
  • prison inmates

结局指标

主要结局

presence of hypospadia

时间窗: 1 month

to compare the incidence of hypospadias in newborns in the Picardie region exposed to pesticides and in those not exposed.

次要结局

  • prevalence of hypospadias and each of its forms in the Picardie region(1 year)
  • the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.(1 year)
  • levels of endocrine disruptors(day 1 , 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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