Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: protocolized interview and prevention messages.
- Who it may be relevant to
- Registry conditions: Pregnancy, Environmental Exposure, Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G
Overview
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.
Detailed description
it is now recognized that there is a link between certain environmental exposures (occupational and extra-occupational) and reproductive pathologies. During pregnancy, environmental exposures are associated with an increased risk of spontaneous miscarriage, congenital malformations, certain adverse outcomes (fetal death in utero, intrauterine growth retardation, prematurity) and could also increase the risk of chronic disease in childhood and adulthood (hypothesis of developmental origins of health and disease), and have transgenerational effects. Intervention studies have shown efficacy in reducing exposures to certain chemicals, particularly by reducing exposure to cosmetics. In the scientific literature, a pre-conception visit is recommended to identify environmental exposures. In France, platforms are dedicated to the evaluation of environmental exposures in patients with fertility disorders and pregnancy-related pathologies and provide support for the implementation of targeted prevention actions.
The intervention is taken care of by the PREVENIR platforms. This 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.
Interventions
- Other protocolized interview and prevention messages
This 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.
Primary outcome measures
- Urinary phenoxyacetic acid concentration [Time frame: 3 months]
Secondary outcome measures (12)
- Urinary levels of pyrethroids [Time frame: 3 months]
- Occupational exposures characterization [Time frame: 3 months]
- Chemical exposome [Time frame: 3 month]
- Endogenous metabolome [Time frame: 3 months]
- Exhaled CO concentration [Time frame: 3 months]
- Urinary phenoxyacetic acid concentration [Time frame: 3 months]
- Transferability of the intervention [Time frame: 5 months]
- Professionals' perceptions [Time frame: 5 months]
- Professionals' and patients' appreciation and perceived effectiveness [Time frame: 5 months]
- Determinants influencing patients' engagement [Time frame: 5 months]
- Implementation-related factors [Time frame: 5 months]
- Proportion of individuals exposed to occupational reproductive risk factors [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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
For qualitative study:
- Professionnal working within PREVENIR platforms
- Women included in the intervention group and who agreed with participating
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Delva F, Sentilhes L, Francis-Oliviero F, Bessonneau V, Sunyach C, Audouin C, Paris C, Haddad B, Matrat M, Pairon JC, Belacel M, Sitta R, Roberts T, Bretelle F, Garlantezec R. Evaluation of the efficacy of PREVENIR (PREVention ENvIronment Reproduction) platforms on urinary markers of chemical exposure in pregnant women: protocol for an unblinded randomised clinical trial (PREVENIR-G). BMJ Open. 20 PMID 41213668
Identifiers
NCT: NCT06642818 · CHUBX 2022/21