Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Urinary phenoxyacetic acid concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
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.
干预措施: protocolized interview and prevention messages (Other)
Non-intervention group
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.
结局指标
主要结局
Urinary phenoxyacetic acid concentration
时间窗: 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.
次要结局
- Urinary levels of pyrethroids(3 months)
- Occupational exposures characterization(3 months)
- Chemical exposome(3 month)
- Endogenous metabolome(3 months)
- Exhaled CO concentration(3 months)
- Urinary phenoxyacetic acid concentration(3 months)
- Transferability of the intervention(5 months)
- Professionals' perceptions(5 months)
- Professionals' and patients' appreciation and perceived effectiveness(5 months)
- Determinants influencing patients' engagement(5 months)
- Implementation-related factors(5 months)
- Proportion of individuals exposed to occupational reproductive risk factors(3 months)
- Urinary levels of parabens(3 months)
- Urinary levels of phthalates(3 months)
- Urinary levels of bisphenols(3 months)