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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805491
Other study ID # PI10-DR-HARAUX
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
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Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A