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Trial record 31 of 117 for:    "Penile Disease"

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

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ClinicalTrials.gov Identifier: NCT02805491
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment
Hypospadias 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.


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Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
Actual Study Start Date : March 3, 2011
Actual Primary Completion Date : December 20, 2014
Actual Study Completion Date : December 20, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pesticides

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




Primary Outcome Measures :
  1. presence of hypospadia [ Time Frame: 1 month ]
    to compare the incidence of hypospadias in newborns in the Picardie region exposed to pesticides and in those not exposed.


Secondary Outcome Measures :
  1. prevalence of hypospadias and each of its forms in the Picardie region [ Time Frame: 1 year ]
    meconium analysis

  2. the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening. [ Time Frame: 1 year ]
    meconium analysis

  3. levels of endocrine disruptors [ Time Frame: day 1 , 1 month ]
    meconium analysis


Biospecimen Retention:   Samples Without DNA
meconium


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805491


Locations
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France
CH Abbeville
Abbeville, France, 80142
CHU Amiens
Amiens, France, 80054
Groupe Santé Victor Pauchet
Amiens, France, 80094
CH Chateau Thierry
Chateau Thierry, France, 02405
CH Chauny
Chauny, France, 02303
CH Compiegne
Compiègne, France, 60321
CH Creil
Creil, France, 60109
CH Laon
Laon, France, 02001
CH Péronne
Péronne, France, 80201
CH Saint Quentin
Saint Quentin, France, 02321
CH Senlis
Senlis, France, 60309
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Elodie HARAUX, PhD CHU Amiens

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02805491     History of Changes
Other Study ID Numbers: PI10-DR-HARAUX
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Hypospadias
newborns
pesticide
Picardie

Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities