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

Официальное название

Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms on Urinary Markers of Chemical Exposures - Unblinded Randomized Clinical Trial. PREVENIR-G

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое protocolized interview and prevention messages
  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.

Первичные конечные точки

• Urinary phenoxyacetic acid concentration [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Urinary levels of pyrethroids [Срок оценки: 3 months]
• Occupational exposures characterization [Срок оценки: 3 months]
• Chemical exposome [Срок оценки: 3 month]
• Endogenous metabolome [Срок оценки: 3 months]
• Exhaled CO concentration [Срок оценки: 3 months]
• Urinary phenoxyacetic acid concentration [Срок оценки: 3 months]
• Transferability of the intervention [Срок оценки: 5 months]
• Professionals' perceptions [Срок оценки: 5 months]
• Professionals' and patients' appreciation and perceived effectiveness [Срок оценки: 5 months]
• Determinants influencing patients' engagement [Срок оценки: 5 months]
• Implementation-related factors [Срок оценки: 5 months]
• Proportion of individuals exposed to occupational reproductive risk factors [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. 20 PMID 41213668

Идентификаторы

NCT: NCT06642818 · CHUBX 2022/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗