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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03261245
Other study ID # MARIET AOI 2016
Secondary ID
Status Recruiting
Phase N/A
First received August 23, 2017
Last updated August 23, 2017
Start date March 2016
Est. completion date March 2018

Study information

Verified date August 2017
Source Centre Hospitalier Universitaire Dijon
Contact Anne-Sophie MARIET
Phone 03.80.29.55.74
Email anne-sophie.mariet@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 hypertension disorders during pregnancy

- 2120 controls (women who did not experience a hypertension disorder during pregnancy)


Recruitment information / eligibility

Status Recruiting
Enrollment 2650
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Hypertension
  • Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009

Locations

Country Name City State
France CHU de BESANCON Besancon
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Onset of a hypertension disorder during pregnancy at baseline