Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial

Trials

Fabrice Pierre¹  Pascale Pierre-Eugène²  Anne-Sophie Gourgues²  Nicolas Venisse³  Sylvie Rabouan⁴  Sarah Ayraud-Thevenot⁴  Guillaume Cambien⁴  Houria E. L. Ouazzani⁵  Marion Albouy-Llaty⁵  Antoine Dupuis⁵  Virginie Migeot⁵  Steeve Rouillon⁶  Lynda Sifer-Rivière⁷ 

[1] BioSPharm Pole, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Department of Obstetrics and Gynecology and Reproductive Medicine, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;BioSPharm Pole, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Faculty of Medicine and Pharmacy, University of Poitiers, 6 rue de la Milétrie, 86000, Poitiers, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Faculty of Medicine and Pharmacy, University of Poitiers, 6 rue de la Milétrie, 86000, Poitiers, France;BioSPharm Pole, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Faculty of Medicine and Pharmacy, University of Poitiers, 6 rue de la Milétrie, 86000, Poitiers, France;BioSPharm Pole, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;UMR CNRS 7285, IC2MP, Poitiers, France;Health-Endocrine Disruptors-EXposome (HEDEX), INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Milétrie, 86021, Poitiers CEDEX, France;Research Center of Medicine, Sciences, Health and Society (Cermes 3), EHESS, University of Paris Descartes, Villejuif, France;

关键词: Endocrine disruptors;    Maternal exposure;    Pregnancy;    Environmental health;    Intervention research;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05813-5

来源: Springer

【 摘 要 】

BackgroundThe suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These interventions should ideally be applied during critical windows like pregnancy. Perinatal environmental health education interventions may help to reduce EDC exposure during pregnancy.Methods/designPREVED (Pregnancy, PreVention, Endocrine Disruptors) is an open-label randomized controlled trial assessing the impact of environmental health education intervention on EDC exposure during pregnancy. Inclusion, consent, and randomization take place during the first trimester. The participants are randomly allocated into three groups: (i) control group (information leaflet on EDCs), (ii) intervention group in neutral location (information leaflet and workshops in a meeting room), and (iii) intervention group in contextualized location (information leaflet and workshops in a real apartment). Workshops are organized between the second and third trimesters of pregnancy. Main outcome is the percentage of participants who reported consuming manufactured/industrial food. Secondary outcomes are as follows: (i) psycho-social dimensions, (ii) EDC concentrations in urine, (iii) EDC concentration in colostrum, and (iv) percentage of participants who reported consuming paraben-free personal care products.DiscussionPREVED is a ground-breaking intervention research project dedicated to perinatal environmental health education that aims to identify pollutant sources in daily life and to offer accessible and realistic alternative solutions, by promoting the sharing of know-how and experience in a positive and non-alarmist approach.Trial registrationClinicalTrials.gov: NCT03233984 (current status: ongoing). Retrospectively registered on 31 July 2017 (https://clinicaltrials.gov/ct2/show/NCT03233984) because when the first participant was enrolled in this non-drug intervention, ClinicalTrials.gov was centered in therapeutic trials.The World Health Organization Trial Registration Data Set is in Additional file 1.

【 授权许可】

CC BY