PregnancyPREVENIR-GNCT06642818
Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms
A study testing protocolized interview and prevention messages in people with Pregnancy and Environmental Exposure, run by University Hospital, Bordeaux.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy, Environmental Exposure, Prevention
- What is being tested?
- protocolized interview and prevention messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G
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.
Read the 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.
- Conditions
- Pregnancy, Environmental Exposure, Prevention
- Being tested
- protocolized interview and prevention messages
- Keywords
- Pregnancy, Environmental exposure, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolized interview and prevention messagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (15)
Urinary levels of pyrethroids
Difference in urinary levels of pyrethroids between the intervention and non-intervention groups between baseline and 3 months post intervention
Measured: 3 months
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.
Measured: 3 months
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)
Measured: 3 month
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)
Measured: 3 months
Exhaled CO concentration
Exhaled CO concentration in air between the intervention and non-intervention groups at 3 months post-intervention
Measured: 3 months
Urinary phenoxyacetic acid concentration
Urinary phenoxyacetic acid concentration described according to socio-professional categories
Measured: 3 months
Transferability of the intervention
It will be assessed by examining the dimensions of reach, effectiveness, adoption, implementation and sustainability. It will be measured using a qualitative approach through interviews of professionals and patients. To assess transferability based on validated criteria, we will draw upon established frameworks such as RE-AIM, PARiHS, and TIDieR, which consider multiple factors: relevance to other contexts, local feasibility, social acceptability, and adaptability without loss of effectiveness. The aim is to generate evidence-based recommendations regarding the adaptations required for implementation in alternative settings, to identify the minimum enabling conditions for successful transfer, and to highlight critical factors likely to be sensitive to contextual variation. Conducting the qualitative study across diverse platforms and territorial settings will provide a nuanced understanding of how contextual differences shape implementation processes and outcomes.
Measured: 5 months
Professionals' perceptions
Professional perceptions and practices regarding the prevention of environmental exposures will be explored through semi-structured interviews with professionals working within the PREVENIR platforms. The interview guide will be structured around several thematic areas: representations of environmental risks, preventive practices implemented, perceived barriers and facilitators, and the implicit norms shaping action within the platforms. An inductive thematic analysis will be conducted to identify professional and organizational dynamics that may influence the effectiveness of the platforms in the field of environmental exposure prevention
Measured: 5 months
Professionals' and patients' appreciation and perceived effectiveness
The appreciation and perceived effectiveness of the intervention will be explored through semi-structured interviews with professionals and patients. For professionals, the interview guide will cover themes such as their perception of the intervention, its relevance to professional practice, satisfaction with resources and processes, observed impacts in patient follow-up, as well as barriers and facilitators to its implementation within the platforms. For patients, the themes will include understanding of the intervention, lived experience, satisfaction with the support received, perceived impacts on daily life, appropriation of preventive messages, and barriers and suggestions for improvement. An inductive thematic analysis will be conducted to identify key dimensions influencing satisfaction and perceived effectiveness, as well as factors facilitating or hindering the appropriation of the intervention.
Measured: 5 months
Determinants influencing patients' engagement
The determinants influencing patient engagement in the intervention will be explored through semi-structured interviews. The interview guide will address barriers and facilitators to adherence to recommended measures, as well as the nature and extent of behavioral changes related to environmental exposures. Patients' experiences and perceptions will be collected to identify key facilitators and obstacles to effective participation. An inductive thematic analysis will be conducted to illuminate the underlying dynamics that promote or hinder adherence and behavioral modifications within the context of environmental exposure prevention.
Measured: 5 months
Implementation-related factors
Implementation-related factors will be explored through semi-structured interviews incorporating a set of factual questions designed to collect precise data on the context of consultations. These questions will focus on aspects such as the average duration of consultations, the profession of participants, the possible presence of a partner during the interviews, among others. This collection of factual information will be complemented by open-ended questions to deepen the understanding of organizational and relational conditions influencing implementation. The interviews will be analyzed using an inductive thematic approach to highlight the dynamics and constraints associated with these factors.
Measured: 5 months
Proportion of individuals exposed to occupational reproductive risk factors
Proportion of individuals exposed to occupational reproductive risk factors at 3 months, comparing the intervention and control groups
Measured: 3 months
Urinary levels of parabens
Difference in urinary levels of parabens between the intervention and control groups from baseline to 3 months post-intervention
Measured: 3 months
Urinary levels of phthalates
Difference in urinary levels of phthalates between the intervention and control groups from baseline to 3 months post-intervention
Measured: 3 months
Urinary levels of bisphenols
Difference in urinary levels of bisphenols between the intervention and control groups from baseline to 3 months post-intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fleur DELVA, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642818
- Sponsor's protocol ID
- CHUBX 2022/21
- Acronym
- PREVENIR-G
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2025 Nov 9;15(11):e097795. doi: 10.1136/bmjopen-2024-097795.
PubMed 41213668
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G
- ClinicalTrials.gov ID
- NCT06642818
- Acronym / sponsor ID
- PREVENIR-G / CHUBX 2022/21
- Conditions
- Pregnancy, Environmental Exposure, Prevention
- Keywords
- Pregnancy, Environmental exposure, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: protocolized interview and prevention messagesDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Women included in the intervention group and who agreed with participating
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocolized interview and prevention messagesThis 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. | Other | Intervention group |
Primary outcome
Urinary phenoxyacetic acid concentration
Time frame: 3 months
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.
15 secondary outcomes
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
Urinary levels of parabens
Time frame: 3 months
Urinary levels of phthalates
Time frame: 3 months
Urinary levels of bisphenols
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 41213668Delva 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fleur DELVA, MD principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
A study testing protocolized interview and prevention messages in people with Pregnancy and Environmental Exposure, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fleur DELVA, MD (0557821684 ext. 33, fleur.delva@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary phenoxyacetic acid concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.