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

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.

Study Overview

• Status: Recruiting
• Conditions: Prenatal Exposure; Postnatal Exposure
• Intervention / Treatment: Other: Clinical examination

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).

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Eunice NUBRET; Phone Number: +590 590 93 46 86; Email: eunice.nubret@chu-guadeloupe.fr
• Study Contact Backup: Name: Valérie HAMONY-SOTER; Phone Number: +590 590 93 46 77; Email: valerie.soter@chu-guadeloupe.fr

Study Locations

• Guadeloupe
  • Guadeloupe
    • Pointe-à-Pitre, Guadeloupe, Guadeloupe, 97159
      • Recruiting
      • CHU of Guadeloupe
      • Contact: Gulen AYHAN; Phone Number: +590 590 89 43 80; Email: gulen.ayhan@chu-guadeloupe.fr
      • Contact: Luc MULTIGNER; Phone Number: +33 (0) 6 09 41 91 01; Email: luc.multigner@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

peripubertal children; 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.; Other Names: Blood collection,; cognitive tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the start of the study (inclusion visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the start of the study (inclusion visit).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age at established puberty (period for girls, molting for boys)	Collect of the age at which girls had their period and boys molted	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.	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.	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.	At the start of the study (inclusion visit).

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Gulen AYHAN, CHU of Guadeloupe

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Puberty; Development; French West Indies; Endocrine disruptors; Persistent Organic Pollutants; Guadeloupe; Chlordecone; Prenatal Exposure; Postnatal Exposure
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Behavioral Disciplines and Activities; Psychological Tests; Behavior Control; Immobilization; Neuropsychological Tests; Restraint, Physical; Blood Specimen Collection
• Other Study ID Numbers: PAP_RI2_2019/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No