Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009HTA-BQuANCT03261245
Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy
An observational study of Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009
- How many people
- 2,650 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2016to Mar 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who gave birth at Dijon and Besançon CHU between 2005 and 2009
Who may be able to join
- 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
Who cannot join
- Medical termination of pregnancy
- Opposition to the use of their data
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de BESANCON
Besançon, 25000
frédéric MAUNY, 03.81.21.94.94 ext. +33, frederic.mauny@univ-fcomte.fr
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Anne-Sophie MARIET, 03 80 29 55 74 ext. +33, anne-sophie.mariet@chu-dijon.fr
About this study
Official title: 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cas | Onset of a hypertension disorder during pregnancy | |
| Controls | No hypertension disorder during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of a hypertension disorder during pregnancy
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261245
- Sponsor's protocol ID
- MARIET AOI 2016
- Acronym
- HTA-BQuA
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03261245
- Acronym / sponsor ID
- HTA-BQuA / MARIET AOI 2016
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,650 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 24 Aug 2017 (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 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cas | – | –Onset of a hypertension disorder during pregnancy |
| Controls | – | –No hypertension disorder during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who gave birth at Dijon and Besançon CHU between 2005 and 2009
Key inclusion criteria (7 listed)
- 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
- Onset of a hypertension disorder during pregnancy defined according to expert recommendations
- No hypertension disorder during pregnancy
Key exclusion criteria (2 listed)
- Medical termination of pregnancy
- Opposition to the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Onset of a hypertension disorder during pregnancy
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009, run by Centre Hospitalier Universitaire Dijon at 2 sites 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 7 inclusion and 2 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Anne-Sophie MARIET (03.80.29.55.74 ext. +33, anne-sophie.mariet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of a hypertension disorder during pregnancy (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2017.