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Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe (TIMOUNPUBERTY)

C

Centre Hospitalier Universitaire de la Guadeloupe

Status

Enrolling

Conditions

Prenatal Exposure
Postnatal Exposure

Treatments

Other: Clinical examination

Study type

Observational

Funder types

Other

Identifiers

NCT06653660
PAP_RI2_2019/11

Details and patient eligibility

About

In the context of environmental pollution of the French West Indies by chlordecone and questions about health consequences, monitoring at the peripubertal age of children born alive in the TIMOUN cohort is justified in several respects: - existence of an already established mother-child cohort whose live-born children will reach peripubertal ages during the period 2020-2022; - opportunity to verify hypotheses put forward on the basis of toxicological data acquired in laboratory animals and the hormonal characteristics of chlordecone (endocrine disruptor); - strong societal demand for such research to be carried out because of concerns about the sensitivity of children and adolescents to the effects of environmental xenobiotics, in particular on sexual development and the age of puberty; - recommendation of the Scientific Council Chlordecone Inserm - InVS; specific action of the National Plan Chlordecone IV.

Full description

The French West Indies are permanently polluted by chlordecone. It is an organochlorine insecticide used from 1973 to 1993 in Guadeloupe and Martinique to control banana root borers. Its physico-chemical properties give it great stability and are at the origin of its persistence in the environment. Soil, flora and wildlife pollution from chlordecone in the Caribbean was first documented shortly after its introduction in 1973. However, it was not until 1999 that this pollution was extended to waters intended for human consumption and to various local, vegetable and animal, land and aquatic foodstuffs. The population is also affected, as confirmed by impregnation studies, with exposure nowadays occurring mainly through the consumption of contaminated food. The contamination of the French West Indies populations by this insecticide raises many questions about its possible health consequences. In order to assess the effects of chlordecone exposure on child development in Guadeloupian children, a longitudinal and prospective study, the Timoun mother-child cohort, was initiated. Between 2004 and 2007, women in the second trimester of pregnancy who planned to give birth in the public hospitals of Grande-Terre and Basse-Terre (accounting for 70% of all deliveries in Guadeloupe) were invited to participate in the study. Children born to these included women have been enrolled to several follow-ups during the last years (3, 7, 18 months and 7 years of age).

Enrollment

650 estimated patients

Sex

All

Ages

16 to 22 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007) and whose parents agreed to be contacted later.
  • Residing in Guadeloupe at the peripubertal age
  • Affiliation to a social security scheme
  • Agreement to participate in the study and informed consent signed by the minor
  • Study participation agreement and informed consent signed by the parents

Exclusion criteria

  • Refusal to participate in the research

Trial design

650 participants in 1 patient group

peripubertal children
Description:
Children born from a mother whose pregnancy was included in the Timoun cohort (2004 -2007).
Treatment:
Other: Clinical examination

Trial contacts and locations

1

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Central trial contact

Valérie HAMONY-SOTER; Eunice NUBRET

Data sourced from clinicaltrials.gov

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