Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre to evaluate the effectiveness of the platforms on the evolution of phenoxyacetic acid levels measured in the urine at inclusion and 3 months after the intervention for patients who received the intervention compared to patients who did not receive the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All pregnant women less than 24 SA of age referred to the PREVENIR platforms participating in the study for management.
Only women less than 24 SA months pregnant will be included to limit the number of women who gave birth during the study.
More than 18 years old
Professionnal working within PREVENIR platforms
Disqualifiers
Women under court protection, under guardianship or curatorship, severely altered physical and/or psychological health, which, in the opinion of the investigator, may affect the participant's compliance to the study.
Women with an altered medical condition related to prgnancy that may required a therapeutic abortion according to the environmental expert
Non-French speakers
Trial design
Design model
Parallel
Treatments tested in this trial
protocolized interview and prevention messages
Other interventionThis care consists of a consultation carried out by an environmental health expert (midwife, environmental health engineer) from the PREVENIR platforms. This consultation is carried out through a protocolized interview already developed which allows the identification of exposure to risk factors on reproduction. During the interview, prevention messages targeted at the exposures identified during the interview are delivered.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Non-intervention groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Urinary phenoxyacetic acid concentration
Difference in urinary phenoxyacetic acid concentration between inclusion and 3 months after the intervention. This difference will be compared between the group that received the intervention and the group that did not.
Time frame
3 monthsSecondary outcomes
1
Urinary levels of pyrethroids
Difference in urinary levels of pyrethroids between the intervention and non-intervention groups between baseline and 3 months post intervention
Time frame
3 months2
Occupational exposures characterization
During the patient interview, participants will be asked about their occupation, the sector of activity of their employer, the company's size and location, as well as their tasks and the tasks of nearby colleagues. The responses will be analyzed by the environmental health expert conducting the interview, enabling the assessment of occupational exposure to reproductive risk factors in terms of probability, frequency, and intensity.
Time frame
3 months3
Chemical exposome
Difference in concentration in urine of chemicals identified by a non-targeted analytical approach (method of analysis without prior knowledge of the substances to be identified)
Time frame
3 month4
Endogenous metabolome
Difference in concentration in urine of metabolite identified by a non-targeted analytical approach (method of analysis without prior knowledge of the substances to be identified)
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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