Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie (HYPOMECO)

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

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

Study Overview

• Status: Completed
• Conditions: Hypospadias
• Intervention / Treatment: Other: meconium; Other: self questionnaires to parents

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.

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• France
  • Abbeville, France, 80142
    • CH Abbeville
  • Amiens, France, 80054
    • CHU Amiens
  • Amiens, France, 80094
    • Groupe Santé Victor Pauchet
  • Chateau Thierry, France, 02405
    • CH Chateau Thierry
  • Chauny, France, 02303
    • CH Chauny
  • Compiègne, France, 60321
    • CH Compiègne
  • Creil, France, 60109
    • CH Creil
  • Laon, France, 02001
    • CH Laon
  • Péronne, France, 80201
    • CH Peronne
  • Saint Quentin, France, 02321
    • CH Saint Quentin
  • Senlis, France, 60309
    • CH Senlis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with hypospadias; parent-child triads as cases (male newborns with hypospadias)	Other: meconium; to evaluate internal exposure to pesticide; Other: self questionnaires to parents; to evaluate external exposure to pesticide
without hypospadias; parent-child triads as controls (male newborns without hypospadias)	Other: meconium; to evaluate internal exposure to pesticide; Other: self questionnaires to parents; to evaluate external exposure to pesticide

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Elodie HARAUX, PhD, CHU Amiens

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2011
• Primary Completion (Actual): December 20, 2014
• Study Completion (Actual): December 20, 2014

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: newborns; Hypospadias; pesticide; Picardie
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: PI10-DR-HARAUX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No