Ethics approval and consent to participate
PREVED study is sponsored by the University Hospital of Poitiers (Contact: Véronique FERRAND-RIGALLAUD). The methodological referent obtained informed consents signed by all participants. Pregnant women are free to leave the study at any time. Additional informed consents were developed for collection and use of additional data and biological specimens for two ancillary studies which were also approved:
- PREVED microbiota
- PREVED placenta
This trial has been approved by Ethics Committee of the University Hospital of Poitiers, France: approval no. 2015-18 RR/MLB/LB and Committee for Personal Protection (CPP) – Ouest III: approval no. 2015-A00031-48 (HPS). It was registered on the Clinical Trials website, ClinicalTrials.gov (NCT03233984).
Results will be published in a peer-reviewed journal. This protocol follows SPIRIT guidelines.
Consent for publication
Not applicable.
Availability of data and materials
Paper questionnaires will be automatically anonymized to be entered on e-CRF anonymously, and then stored in a locked cupboard. Biological samples will be identified only by the anonymity code.
The data sets generated and analyzed during this study are not publicly available. The methodological referent and the doctoral student will have access to the final trial dataset and results will be published in a peer-reviewed journal in 2021 with a defined authoship (Additional file 3). As of now, data have yet to be analyzed.
Competing interests
The authors declare that they have no competing interests.
Funding
The “Fondation de France” brought its financial support for this study by grant no. 2015 00060744. This grant made possible the financing of data collection, the sociological study and also the analysis of urine and colostrum samples. “Fondation de France” had no role in the collection, management, analysis and interpretation of data, nor in writing of report and decision to submit it for publication. Also, we intend to respond to call for proposals in order to disseminate the study's results via seminars and workshops, and to fund the monitoring of the cohort ("PREVED children").
Authors' contributions:
This work is the result of numerous collaborations and exchanges. St.Ro., M.A.-L., V.M., Sy.Ra. designed the protocol. St.Ro., M.A.-L., V.M., Sy.Ra., H.E.-O and DisProSE Group participated in design and validation of the intervention. A.-S.G. and F.P. recruited the women who participated in PREVED study. M.A-.L. and L.S.-R. supervised the human and social sciences approach. St.Ro. and M.A.-L. designed the questionnaires. St.Ro., A.D. and N.V. developed analytical methods for determination of EDCs in urine and colostrum. A.-S.G. was the research nurse of PREVED study. G.C and P.P.E contributed to sample analysis. H.E.-O, St.Ro. and M.A.-L. wrote the paper. H.E.-O and St.Ro contributed equally to this work.
Acknowledgements:
The authors thank the Biological Resource Centre of the University Hospital of Poitiers (no. BB-0033-00068) for storing samples. They would like to thank Adeline Valliccioni, midwife student, Nathalie Morin from “Mutualité française Poitou-Charentes”, Christophe Malvault from IREPS and Sylvie Bonniol from PMI. The authors would like to thank ARS and DREAL Nouvelle-Aquitaine for their support. They also thank Jimmy Ardouin (J.A.), Amélie Cant, Camille Gatien and Alexia Koudou, Master students at the University of Poitiers for their active contributions to the focus group and its analysis.
The authors thank Sandy Bertin, Louise Mignet and Marion Gorgun for their participation in administration of the questionnaire. They would like to thank the DisProSE Group: Celine Airaud, Marion Albouy-Llaty, Lydie Ancelot, Christine Berthome, Sylvie Bonniol, Delphine Charier, Yves Cottet, Marc-Hubert Depret, Marie-Laure Guillemot, Jean-Benoit Hardouin, Helene Le Turdu, Christophe Malvault, Virginie Migeot, Nathalie Morin, François Nivault, Sylvie Rabouan, Lynda Sifer-Rivière. The authors would also like to thank Jean-Benoit Hardouin and Line Enjalbert for their contribution to the validation of the psychosocial questionnaire.
We wish to thank the participating maternities for their help in the recruitment of pregnant women. We likewise wish to thank the participating pregnant women. Finally, we would like to thank Jeffrey Arsham, American English native speaker and English teacher at the University of Poitiers, for his help in preparation of the English version of this publication.