Clinical trial NCT02805491: Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
Official title: Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypospadias
Keywords: Hypospadias
newborns
pesticide
Picardie
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 197
Sex: MALE
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: parent-child triads as cases (male newborns with hypospadias) and parent-child triads as controls (male newborns without hypospadias)

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.

Eligibility criteria: 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

Primary outcomes:
measure: presence of hypospadia
timeFrame: 1 month
Secondary outcomes:
measure: prevalence of hypospadias and each of its forms in the Picardie region
timeFrame: 1 year
measure: the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.
timeFrame: 1 year
measure: levels of endocrine disruptors
timeFrame: day 1 , 1 month
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Amiens
country: France
facility: CHU Amiens
city: Amiens
country: France
facility: Groupe Santé Victor Pauchet
city: Chateau Thierry
country: France
facility: CH Chateau Thierry
city: Chauny
country: France
facility: CH Chauny
city: Compiègne
country: France
facility: CH Compiegne
city: Creil
country: France
facility: CH Creil
city: Laon
country: France
facility: CH Laon
city: Péronne
country: France
facility: CH Péronne
city: Saint Quentin
country: France
facility: CH Saint Quentin
city: Senlis
country: France
facility: CH Senlis
Study officials:
affiliation: CHU Amiens
name: Elodie HARAUX, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haraux E, Tourneux P, Kouakam C, Stephan-Blanchard E, Boudailliez B, Leke A, Klein C, Chardon K. Isolated hypospadias: The impact of prenatal exposure to pesticides, as determined by meconium analysis. Environ Int. 2018 Oct;119:20-25. doi: 10.1016/j.envint.2018.06.002. Epub 2018 Jun 18.