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Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02805491
Acronym
HYPOMECO
Enrollment
197
Registered
2016-06-20
Start date
2011-03-03
Completion date
2014-12-20
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Keywords

Hypospadias, newborns, pesticide, Picardie

Brief summary

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

Detailed 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.

Interventions

to evaluate internal exposure to pesticide

OTHERself questionnaires to parents

to evaluate external exposure to pesticide

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
1 Minutes to 1 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
presence of hypospadia1 monthto compare the incidence of hypospadias in newborns in the Picardie region exposed to pesticides and in those not exposed.

Secondary

MeasureTime frameDescription
prevalence of hypospadias and each of its forms in the Picardie region1 yearmeconium analysis
the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.1 yearmeconium analysis
levels of endocrine disruptorsday 1 , 1 monthmeconium analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026