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

NCT06642818 | Not Yet Recruiting

• 1 other identifier: CHUBX 2022/21
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Environmental Exposure; Prevention

Keywords

Pregnancy; Environmental exposure; Prevention

Outcome Measures

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.

  3 months

Secondary Outcomes (15)

• Urinary levels of pyrethroids

  3 months

• Occupational exposures characterization

  3 months

• Chemical exposome

  3 month

• Endogenous metabolome

  3 months

• Exhaled CO concentration

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: protocolized interview and prevention messages

Non-intervention group

NO INTERVENTION

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.

Interventions

protocolized interview and prevention messages OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Related Publications (1)

• 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. 2025 Nov 9;15(11):e097795. doi: 10.1136/bmjopen-2024-097795.

  PMID: 41213668 DERIVED

Study Officials

• Fleur DELVA, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fleur DELVA, MD

CONTACT

0557821684; fleur.delva@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share