Study protocol to explore the social effects of environmental exposure and lifestyle behaviours on pregnancy outcome: an overview of cohort of pregnant women study.

Introduction: A growing number of international studies have highlighted the adverse consequences of lived experience in the first thousand days of pregnancy and early life on the probability of stillbirth, child mortality, inadequate growth and healthy development during both childhood and adulthood. The lived experience of the fetus inside the womb and at the birth is strongly related to both maternal health during pregnancy and maternal exposure to a set of environmental factors known as 'exposome' characteristics, which include environmental exposure, health behaviours, living conditions, neighbourhood characteristics and socioeconomic profile. The aim of our project is to explore the relationships between exposome characteristics and the health status of pregnant women and their newborns. We are particularly interested in studying the relationships between the social inequality of adverse pregnancy outcomes and (1) short-term exposure to atmospheric pollution (MobiFem project) and (2) pregnancy lifestyle (EnviFem project).

Methods And Analysis: Ours is a prospective, observational and multisite cohort study of pregnant women, involving one teaching hospital across two sites in the Strasbourg metropolitan area.The research team at University Hospital of Strasbourg (HUS) Health collects data on outcomes and individual characteristics from pregnancy registries, clinical records data and questionnaires administered via email to study participants. Recruitment began in February 2021 and will be complete by December 2021. Participants are recruited from first trimester antenatal ultrasound examinations (conducted on weekdays across both sites); each woman meeting our inclusion criteria enters the cohort at the end of her first trimester. Study participants receive a total of three online questionnaires covering sociodemographic characteristics, travel behaviour patterns and lifestyle. Participants complete these questionnaires at recruitment, during the second and third trimester. The level of personal exposure to air pollution is characterised using a dynamic spatiotemporal trajectory model that describes the main daily movements of pregnant women and the time spent in each place frequented. Univariate, multilevel and Bayesian model will be used to investigate the relationships between exposome characteristics and the health status of pregnant women and their newborns.

Ethics And Dissemination: Our research was approved by the Commission de Protection des Personnes (CPP) Ile de France VI (Paris) on 9 December 2020 (File reference No. 20.09.15.41703 ID RCB: 2020-A02580-39 and No. 20 080-42137 IDRCB 2020-A02581-38). The Agence Nationale de Sécurité du Médicament was informed of it on 15 December 2020. Findings from the study will be disseminated through publications and international conferences and through presentation at meetings with local stakeholders, researchers and policy-makers.

Trial Registration Numbers: NCT04705272, NCT04725734.