HypospadiasHYPOMECONCT02805491
Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
An observational study of Hypospadias, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
Trial summary
We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn . Read more about this study
- Who is it for?
- Ages 1 minute to 1 day, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- meconium and self questionnaires to parents
- How many people
- 197 participants
- Where
- 11 sitesFrance
- Study dates
- 3 Mar 2011to 20 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 day
- Men only
- Healthy volunteers accepted
- Child
Study population: parent-child triads as cases (male newborns with hypospadias) and parent-child triads as controls (male newborns without hypospadias)
Who may be able to join
- male newborns
- born after February 1st, 2011, in a maternity hospital/clinic in the Picardie region
Who cannot join
- refusal to participate,
- severe associated disorders
- associated multiple malformation syndromes
- patients not attending the consultation.
- parents under the age of 18
- prison inmates
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Abbeville
Abbeville, 80142
CHU Amiens
Amiens, 80054
Groupe Santé Victor Pauchet
Amiens, 80094
CH Chateau Thierry
Château-Thierry, 02405
CH Chauny
Chauny, 02303
CH Compiegne
Compiègne, 60321
CH Creil
Creil, 60109
CH Laon
Laon, 02001
CH Péronne
Péronne, 80201
CH Saint Quentin
Saint-Quentin, 02321
CH Senlis
Senlis, 60309
About this study
Official title: 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 .
Read the 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.
- Conditions
- Hypospadias
- Being tested
- meconium, self questionnaires to parents
- Keywords
- Hypospadias, newborns, pesticide, Picardie
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meconiumOther
to evaluate internal exposure to pesticide
self questionnaires to parentsOther
to evaluate external exposure to pesticide
| Study group | Role | What they receive |
|---|---|---|
| with hypospadias | parent-child triads as cases (male newborns with hypospadias) Receives: Other: meconium; Other: self questionnaires to parents | |
| without hypospadias | parent-child triads as controls (male newborns without hypospadias) Receives: Other: meconium; Other: self questionnaires to parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of hypospadia
to compare the incidence of hypospadias in newborns in the Picardie region exposed to pesticides and in those not exposed.
Measured: 1 month
Secondary outcomes (3)
prevalence of hypospadias and each of its forms in the Picardie region
meconium analysis
Measured: 1 year
the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.
meconium analysis
Measured: 1 year
levels of endocrine disruptors
meconium analysis
Measured: day 1 , 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start3 Mar 2011
- Primary completion20 Dec 2014
- Study completion20 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie HARAUX, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805491
- Sponsor's protocol ID
- PI10-DR-HARAUX
- Acronym
- HYPOMECO
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29929047
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
- ClinicalTrials.gov ID
- NCT02805491
- Acronym / sponsor ID
- HYPOMECO / PI10-DR-HARAUX
- Conditions
- Hypospadias
- Keywords
- Hypospadias, newborns, pesticide, Picardie
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Mar 2011 (actual)
- Primary completion
- 20 Dec 2014 (actual)
- Study completion
- 20 Dec 2014 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with hypospadias | – | Other: meconium, Other: self questionnaires to parentsparent-child triads as cases (male newborns with hypospadias) |
| without hypospadias | – | Other: meconium, Other: self questionnaires to parentsparent-child triads as controls (male newborns without hypospadias) |
Who may qualify
- Ages
- 1 minute to 1 day
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- parent-child triads as cases (male newborns with hypospadias) and parent-child triads as controls (male newborns without hypospadias)
Key inclusion criteria (2 listed)
- male newborns
- born after February 1st, 2011, in a maternity hospital/clinic in the Picardie region
Key exclusion criteria (6 listed)
- refusal to participate,
- severe associated disorders
- associated multiple malformation syndromes
- patients not attending the consultation.
- parents under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meconiumto evaluate internal exposure to pesticide | Other | with hypospadias, without hypospadias |
| self questionnaires to parentsto evaluate external exposure to pesticide | Other | with hypospadias, without hypospadias |
Primary outcome
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.
3 secondary outcomes
prevalence of hypospadias and each of its forms in the Picardie region
Time frame: 1 year
the proportions of associated endocrine disorders (regardless of the severity of hypospadias) through systematic screening.
Time frame: 1 year
levels of endocrine disruptors
Time frame: day 1 , 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 29929047Haraux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie HARAUX, PhD principal investigator
CHU Amiens
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadias, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of hypospadia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.