Trials / Completed
CompletedNCT02805491
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 197 (actual)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Academic / Other
- Sex
- Male
- Age
- 1 Minute – 1 Day
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | meconium | to evaluate internal exposure to pesticide |
| OTHER | self questionnaires to parents | to evaluate external exposure to pesticide |
Timeline
- Start date
- 2011-03-03
- Primary completion
- 2014-12-20
- Completion
- 2014-12-20
- First posted
- 2016-06-20
- Last updated
- 2018-08-02
Locations
11 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02805491. Inclusion in this directory is not an endorsement.