Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)

Completed

• Conditions: Metallic Trace Elements; Metal-type Environmental Pollutants
• Interventions: Diagnostic Test: Toxseek test

• Registration Number: NCT05144438
• Lead Sponsor: Elsan

Brief Summary

A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-03
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-03
• Primary Completion: 2022-09-03
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 185

Inclusion Criteria

• Women over 18 years old
• Patient with desire to conceive
• 1st trimester of pregnancy
• Patient having been informed of the study and not opposing the use of the data collected
• Affiliate or beneficiary of a social security scheme

Exclusion Criteria

• Women under 18 years old
• 2nd and 3rd trimester of pregnancy
• Patient objecting to the use of the data collected
• Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women or woman in desire for conception	Toxseek test	Towseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire

Primary Outcome Measures

Name	Time	Method
Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.	4 months	The patient will be considered "successful" for the reduction of the exposure level, if all the metals with a "risky" exposure level during the 1st screening have gone to an exposure level "to be monitored" or "acceptable" during the 2nd screening.

Trial Locations

Locations (1)

Pôle médical Saint Bernard; 🇫🇷 Saint-Rémy-de-Provence, France