- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261245
Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy (HTA-BQuA)
August 23, 2017 updated by: Centre Hospitalier Universitaire Dijon
Hypertension Disorders During Pregnancy and Multi-exposure to Environmental Noise and Atmospheric Pollution in an Urban Setting: Case-control Study in Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009
This retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy
It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and 2009 split into two groups:
- 530 cases (women who experienced hypertension disorders during pregnancy
- 2120 controls (women who did not experience a hypertension disorder during pregnancy)
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
2650
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besancon, France, 25000
- Recruiting
- CHU de Besançon
-
Contact:
- frédéric MAUNY
- Phone Number: +33 03.81.21.94.94
- Email: frederic.mauny@univ-fcomte.fr
-
Dijon, France, 21079
- Recruiting
- Chu Dijon Bourgogne
-
Contact:
- Anne-Sophie MARIET
- Phone Number: +33 03 80 29 55 74
- Email: anne-sophie.mariet@chu-dijon.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women who gave birth at Dijon and Besançon CHU between 2005 and 2009
Description
Inclusion Criteria:
- Women living in Besançon or one of the 15 communes of the Dijon conurbation
- Who gave birth at Dijon or Besançon CHU
- Between 1st January 2005 and 31st December 2009
Criterion for the inclusion of cases:
- Onset of a hypertension disorder during pregnancy defined according to expert recommendations
Criterion for the inclusion of controls:
- No hypertension disorder during pregnancy
Exclusion Criteria:
- Medical termination of pregnancy
- Opposition to the use of their data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cas
Onset of a hypertension disorder during pregnancy
|
|
Controls
No hypertension disorder during pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Onset of a hypertension disorder during pregnancy
Time Frame: at baseline
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
August 23, 2017
First Submitted That Met QC Criteria
August 23, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MARIET AOI 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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