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

Hypospadias Clinical Trial

— HYPOMECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805491
• Other study ID #: PI10-DR-HARAUX
• Status: Completed
• Start date: March 3, 2011
• Est. completion date: December 20, 2014

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 20, 2014
• Est. primary completion date: December 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Hypospadias

Intervention

Other:
• meconium
to evaluate internal exposure to pesticide
• self questionnaires to parents
to evaluate external exposure to pesticide

Locations

Country	Name	City	State
France	CH Abbeville	Abbeville
France	CHU Amiens	Amiens
France	Groupe Santé Victor Pauchet	Amiens
France	CH Chateau Thierry	Chateau Thierry
France	CH Chauny	Chauny
France	CH Compiegne	Compiègne
France	CH Creil	Creil
France	CH Laon	Laon
France	CH Péronne	Péronne
France	CH Saint Quentin	Saint Quentin
France	CH Senlis	Senlis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	prevalence of hypospadias and each of its forms in the Picardie region	meconium analysis	1 year
Secondary	the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.	meconium analysis	1 year
Secondary	levels of endocrine disruptors	meconium analysis	day 1 , 1 month