Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie (HYPOMECO)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Hypospadias

Treatments: Other: self questionnaires to parents; Other: meconium

Study type: Observational

Funder types: Other

Identifiers

NCT02805491

PI10-DR-HARAUX

Details and patient eligibility

About

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

Full description

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.

Enrollment: 197 patients

Sex: Male

Ages: 1 minute to 1 day old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

197 participants in 2 patient groups

with hypospadias

Description:

parent-child triads as cases (male newborns with hypospadias)

Treatment:

Other: self questionnaires to parents

Other: meconium

without hypospadias

Description:

parent-child triads as controls (male newborns without hypospadias)

Treatment:

Other: self questionnaires to parents

Other: meconium