Clinical Trial: Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: presence of hypospadia [ Time Frame: 1 month ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: June 8, 2016
Date Started: March 2011
Date Completion:
Last Updated: June 15, 2016
Last Verified: June 2016