PregnancyMOBIFEMNCT04725734
Air Pollution and Daily Mobility of Pregnant Women Identification of Critical Windows of Exposure
An observational study of Pregnancy and Low Birth Weight, run by University Hospital, Strasbourg, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Low Birth Weight, Preterm Birth
- What is being tested?
- Pregnant women
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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")
Who cannot join
- premature delivery threats
- placenta previa
- twin pregnancy
- pre-eclampsia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Schiltigheim, 67303
Virginie HAMANN, +33 3 69 55 43 93, virginie.hamann@chru-strasbourg.fr
Virginie HAMANN
About this study
Official title: 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.
- Conditions
- Pregnancy, Low Birth Weight, Preterm Birth, Air Pollution
- Being tested
- Pregnant women
- Keywords
- social inequalities
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant womenOther
The patients will complete a questionnaire for each quarter
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of the newborn
Estimation of fetal weight
Measured: 7 months
Characteristics of the newborn
Estimation of birth weight
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Feb 2021
- Primary completion4 Feb 2021
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie HAMANN, Principal investigator, Les Hôpitaux Universitaires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725734
- Sponsor's protocol ID
- 8000
- Acronym
- MOBIFEM
- Status last verified
- Mar 2021
- First submitted
- 5 Oct 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36115665
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Pollution and Daily Mobility of Pregnant Women in the Eurometropole: Identification of Critical Windows of Exposure During Pregnancy
- ClinicalTrials.gov ID
- NCT04725734
- Acronym / sponsor ID
- MOBIFEM / 8000
- Conditions
- Pregnancy, Low Birth Weight, Preterm Birth, Air Pollution
- Keywords
- social inequalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- refusal to participate in the study
Key exclusion criteria (4 listed)
- premature delivery threats
- placenta previa
- twin pregnancy
- pre-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant womenThe patients will complete a questionnaire for each quarter | Other | – |
Primary outcome
Characteristics of the newborn
Time frame: 7 months
Estimation of fetal weight
Characteristics of the newborn
Time frame: 7 months
Estimation of birth weight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 36115665Simoncic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie HAMANN principal investigator
Les Hôpitaux Universitaires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Low Birth Weight, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie HAMANN (+ 3 69 55 43 93, virginie.hamann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of the newborn (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.