Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms (PREVENIR-G)

University Hospital of Bordeaux

Status: Not yet enrolling

Conditions: Prevention; Environmental Exposure; Pregnancy

Treatments: Other: protocolized interview and prevention messages

Study type: Interventional

Funder types: Other

Identifiers

NCT06642818

CHUBX 2022/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Intervention group

Experimental group

Description:

During the inclusion visit, urine collection jars will be given to the patient for collection at inclusion and at 3 months. Within the week after the inclusion visit: urine collection will be performed twice a day during 3 days at the patient's home and will be stored in the refrigerator at the participants' home. In the week following this collection, the PREVENIR platforms will be used. At three months, the clinical research officer will contact the patient to remind her of the need to collect urine twice a day during 3 days. This urine collection will be carried out with the same organization as at inclusion. Then, after this urine collection, all the participating women will be interviewed, with a questionnaire identical to the one used for the face-to-face inclusion, in order to allow for the measurement of exhaled Carbon Monoxide (CO). Within 3 to 5 months after inclusion, participating women of the intervention group only,will be invited to participate to the qualitative study.

Treatment:

Other: protocolized interview and prevention messages

Non-intervention group

No Intervention group

Description:

During the inclusion visit, urine collection jars will be given to the patient for collection at inclusion and at 3 months. Within the week after the inclusion visit: urine collection will be performed twice a day during 3 days at the patient's home and will be stored in the refrigerator at the participants' home. At three months, the clinical research officer will contact the patient to remind her of the need to collect urine twice a day during 3 days. This urine collection will be carried out with the same organization as at inclusion. Then, after this urine collection, all the participating women will be interviewed, with a questionnaire identical to the one used for the face-to-face inclusion, in order to allow for the measurement of exhaled CO. In the non-intervention group, the full intervention will take place at this time. The control group is a waiting list type control group. The procedure will be performed at the end of the study, i.e. three months after inclusion.