Air Pollution and Daily Mobility of Pregnant Women Identification of Critical Windows of Exposure (MOBIFEM)

Air Pollution and Daily Mobility of Pregnant Women in the Eurometropole: Identification of Critical Windows of Exposure During Pregnancy

This study is conducted to assess the role of pregnant women's daily mobility living in the Eurometropole of Strasbourg in a context of the existence of environmental exposure disparities (PM10, PM2.5, NO2). Furthermore, this study will tend to identify the critical windows of exposure and of greater risk of the adverse pregnancy outcomes as low birth weight and prematurity.

A second question addressed in this work is to assess the relationship between the pregnant women's socio-economic status and the air pollution exposure (PM10, PM2.5, NO2).taking into account the spatio-temporal variations of the exposure as well as the critical windows of exposure during pregnancy.

The present work deals with the following question "how does the combination of environmental exposure, socio-economic status and women's daily mobility, could contribute to socio-spatial inequalities in the health of the newborn? The underlying hypothesis is that the accumulation, in given area, of environmental exposures (as PM10, PM2.5 and NO2), of unfavorable living conditions (socio-economic environment) and individual factors (specific spatio-temporal trajectory) would induce an increased risk for the health of the newborn, (more particularly in terms of birth weight and term of birth). This hypothesis is structured 4 sub-hypotheses: i) The misclassification of exposure is socially distributed among pregnant women living in the Eurometropole of Strasbourg. ii) Beyond maternal and fetal characteristics, pregnant women who reside in a more socio-economically deprived neighborhood and / or with higher levels of environmental exposure to PM10, PM2.5 and NO2 are more at risk of preterm newborn and low birth weight newborn. iii) The accumulation of environmental exposures of the pregnant women and their daily mobility over their territory during the pregnancy increase the health inequalities of the newborn. iv) The critical windows of fetal exposure to pollutants is related to the socioeconomic level of their neighborhood and to the daily mobility of the women in their territory during pregnancy. Women are included in the study at the time of their first or second trimester ultrasound. Here are the tools used in the study: Descriptive survey of their idividuals characteristics, descriptive survey of women's mobility to assess their exposure during each trimester of pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Preterm Birth; Low Birth Weight; Air Pollution
• Intervention / Treatment: Other: Pregnant women

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Virginie HAMANN; Phone Number: + 3 69 55 43 93; Email: virginie.hamann@chru-strasbourg.fr

Study Locations

• France
  • Schiltigheim, France, 67303
    • Recruiting
    • Les Hôpitaux Universitaires de Strasbourg
    • Contact: Virginie HAMANN; Phone Number: +33 3 69 55 43 93; Email: virginie.hamann@chru-strasbourg.fr
    • Principal Investigator: Virginie HAMANN
    • Sub-Investigator: Philippe DERUELLE
    • Sub-Investigator: Nicolas SANANES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, include at 1st or 2nd trimester in the Hautepierre and CMCO ultrasound department.

The period of inclusion should extend from 1 October 2020 to 31 October 2021 with a duration of participation of each subject of 9 months.

Description

Inclusion Criteria:

• Pregnant women dwelling in the Eurometropole of Strasbourg
• Women who have done ultrasound monitoring in the HUS (Hopitaux Universitaires de Strasbourg)
• Good understanding of the French language
• Women who give her signed agreement of non-opposition to research and / or who give her signed consent for the data collect

Non-inclusion criteria:

• refusal to participate in the study
• under-age women (<18 years old)
• women who not have a clear understanding of the information (emergency situation, comprehension problems…)
• Women must not be under tutorship or curatorship or under the protection of a conservator ("sauvegarde de justice")

Exclusion criteria:

• premature delivery threats
• placenta previa
• twin pregnancy
• pre-eclampsia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the newborn	Estimation of fetal weight	7 months
Characteristics of the newborn	Estimation of birth weight	7 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Virginie HAMANN, Les Hôpitaux Universitaires

Publications and helpful links

General Publications

• Simoncic V, Hamann V, Huber L, Deruelle P, Sananes N, Enaux C, Alter M, Schillinger C, Deguen S, Kihal-Talantikite W. Study protocol to explore the social effects of environmental exposure and lifestyle behaviours on pregnancy outcome: an overview of cohort of pregnant women study. BMJ Open. 2022 Sep 17;12(9):e058883. doi: 10.1136/bmjopen-2021-058883.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): February 4, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: social inequalities
• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Birth Weight
• Other Study ID Numbers: 8000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No