Clinical trial NCT06642818: Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms
Official title: Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Environmental Exposure
Prevention
Keywords: Pregnancy
Environmental exposure
Prevention
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre.
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Urinary phenoxyacetic acid concentration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Fleur DELVA, MD
role: PRINCIPAL_INVESTIGATOR
References: