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

NCT05144438 | Completed

• 1 other identifier: 2020-A01954-35
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Metallic Trace Elements; Metal-type Environmental Pollutants

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.

  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.

  4 months

Study Arms (1)

Pregnant women or woman in desire for conception

Towseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire

Diagnostic Test: Toxseek test

Interventions

Toxseek test DIAGNOSTIC_TEST

Hair taking

Pregnant women or woman in desire for conception

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women, over 18 years old, pregnant (first trimester) or desires conception

You may qualify if:

• Women over 18 years old
• Patient with desire to conceive
• st 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

You may not qualify if:

• Women under 18 years old
• nd 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

Sponsors & Collaborators

• Elsan: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Pôle médical Saint Bernard

Saint-Rémy-de-Provence, 13210, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 3, 2021
• Study Start: January 3, 2021
• Primary Completion: September 3, 2022
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

FR (1)