Prenatal ExposureTIMOUNPUBERTYNCT06653660
Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
An observational study of Prenatal Exposure and Postnatal Exposure, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Prenatal Exposure, Postnatal Exposure
- What is being tested?
- Clinical examination
- How many people
- 650 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 19 Dec 2022to 19 Dec 2026
- Phase
- Observational
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 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU of Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
Gulen AYHAN, +590 590 89 43 80, gulen.ayhan@chu-guadeloupe.fr
Luc MULTIGNER, +33 (0) 6 09 41 91 01, luc.multigner@inserm.fr
About this study
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.
Read the detailed 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).
- Conditions
- Prenatal Exposure, Postnatal Exposure
- Being tested
- Clinical examination
- Keywords
- Prenatal Exposure, Postnatal Exposure, Chlordecone, Persistent Organic Pollutants, Endocrine disruptors, Puberty, Development, Guadeloupe, French West Indies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
Also called Blood collection,, cognitive tests
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.
| Study group | Role | What they receive |
|---|---|---|
| peripubertal children | Children born from a mother whose pregnancy was included in the Timoun cohort (2004 -2007). Receives: Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the start of the study (inclusion visit)
Secondary outcomes (1)
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.
Measured: At the start of the study (inclusion visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start19 Dec 2022
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal ExposureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulen AYHAN, Principal investigator, CHU of Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653660
- Sponsor's protocol ID
- PAP_RI2_2019/11
- Acronym
- TIMOUNPUBERTY
- Status last verified
- Nov 2025
- First submitted
- 6 Sep 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No