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

Study Overview
=================
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.

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

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Other: meconium
* Other: self questionnaires to parents


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Day

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with hypospadias<br>parent-child triads as cases (male newborns with hypospadias) | Other: meconium<br>* to evaluate internal exposure to pesticide<br>Other: self questionnaires to parents<br>* to evaluate external exposure to pesticide<br>|
| without hypospadias<br>parent-child triads as controls (male newborns without hypospadias) | Other: meconium<br>* to evaluate internal exposure to pesticide<br>Other: self questionnaires to parents<br>* to evaluate external exposure to pesticide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of hypospadia | to compare the incidence of hypospadias in newborns in the Picardie region exposed to pesticides and in those not exposed. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of hypospadias and each of its forms in the Picardie region | meconium analysis | 1 year | 
| the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening. | meconium analysis | 1 year | 
| levels of endocrine disruptors | meconium analysis | day 1 , 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypospadias, newborns, pesticide, Picardie