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
1 other identifier
observational
197
1 country
11
Brief Summary
We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2011
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2014
CompletedFirst Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedAugust 2, 2018
July 1, 2018
3.8 years
June 8, 2016
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
prevalence of hypospadias and each of its forms in the Picardie region
1 year
the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.
1 year
levels of endocrine disruptors
day 1 , 1 month
Study Arms (2)
with hypospadias
parent-child triads as cases (male newborns with hypospadias)
without hypospadias
parent-child triads as controls (male newborns without hypospadias)
Interventions
to evaluate external exposure to pesticide
Eligibility Criteria
parent-child triads as cases (male newborns with hypospadias) and parent-child triads as controls (male newborns without hypospadias)
You may qualify if:
- male newborns
- born after February 1st, 2011, in a maternity hospital/clinic in the Picardie region
You may not qualify if:
- refusal to participate,
- severe associated disorders
- associated multiple malformation syndromes
- patients not attending the consultation.
- parents under the age of 18
- prison inmates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CH Abbeville
Abbeville, 80142, France
CHU Amiens
Amiens, 80054, France
Groupe Santé Victor Pauchet
Amiens, 80094, France
CH Chauny
Chauny, 02303, France
CH Chateau Thierry
Château-Thierry, 02405, France
CH Compiegne
Compiègne, 60321, France
CH Creil
Creil, 60109, France
CH Laon
Laon, 02001, France
CH Péronne
Péronne, 80201, France
CH Saint Quentin
Saint-Quentin, 02321, France
CH Senlis
Senlis, 60309, France
Related Publications (1)
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.
PMID: 29929047DERIVED
Biospecimen
meconium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elodie HARAUX, PhD
CHU Amiens
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 20, 2016
Study Start
March 3, 2011
Primary Completion
December 20, 2014
Study Completion
December 20, 2014
Last Updated
August 2, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share