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

Pregnancy Clinical Trial

— MOBIFEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725734
• Other study ID #: 8000
• Status: Recruiting
• Start date: February 4, 2021
• Est. completion date: January 2022

Study information

• Verified date: March 2021
• Source: University Hospital, Strasbourg, France
• Contact: Virginie HAMANN
• Phone: + 3 69 55 43 93
• Email: virginie.hamann[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 2022
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Air Pollution
• Birth Weight
• Low Birth Weight
• Pregnancy
• Premature Birth
• Preterm Birth

Intervention

Other:
• Pregnant women
The patients will complete a questionnaire for each quarter

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Schiltigheim

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of the newborn	Estimation of fetal weight	7 months
Primary	Characteristics of the newborn	Estimation of birth weight	7 months