An observational study in Prenatal Exposure and Postnatal Exposure, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 16 Years to 22 Years. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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.
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).
Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children born from a mother whose pregnancy was included in the Timoun cohort (2004 -2007).
Other: Clinical examination
For the aim of the present study, we will follow-up children born alive in the TIMOUN cohort at peripubertal age. Questionnaires will be administered to parents on the child's health and lifestyle. Stature-weight anthropometric and cardio-dynamic measurements of the child will be obtained. Scores on three cognitive tests will be obtained. Furthermore, steroid hormones and chlordecone in the child's peripheral blood will be determined.
Also known as: Blood collection,, cognitive tests
Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory
: Cognitive tests (25 min for the 3 Wechsler Intelligence Scale for Children V subscales). The Wechsler Intelligence Scale for Children-V is the most scientifically valid intelligence test for children and adolescents. It can be used to determine a child's or teenager's intelligence quotient (IQ), to obtain their complete cognitive profile and the level of the 5 main components of cognitive intelligence
Time frame: At the start of the study (inclusion visit)
Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves)
Collect of the age at which children and adolescents begin to develop adult physical characteristics, such as breasts or pubic hair, and become able to procreate.
Time frame: At the start of the study (inclusion visit).
Age at established puberty (period for girls, molting for boys)
Collect of the age at which girls had their period and boys molted
Time frame: At the start of the study (inclusion visit) or through study completion, an average of two years, for girls who had their period and boys molted.
Plasma concentrations of steroid hormones
Blood collection for hormonal and organochlorine pollutants dosage.
Time frame: At the start of the study (inclusion visit).
Blood pressure
Seated resting blood pressure will be measured using an automatic tensiometer an automatic blood pressure monitor, with two measurements separated by 15 to 30 minutes.
Time frame: At the start of the study (inclusion visit).
heart rate
heart ratewill be measured using an automatic tensiometer an automatic blood pressure monitor, with two measurements separated by 15 to 30 minutes.
Time frame: At the start of the study (inclusion visit).
Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.
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Centre Hospitalier Universitaire de la Guadeloupe