NCT03261245

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 23, 2017

Last Update Submit

August 23, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Onset of a hypertension disorder during pregnancy

    at baseline

Study Arms (2)

Cas

Onset of a hypertension disorder during pregnancy

Controls

No hypertension disorder during pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who gave birth at Dijon and Besançon CHU between 2005 and 2009

You may qualify if:

  • 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

You may not qualify if:

  • Medical termination of pregnancy
  • Opposition to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de BESANCON

Besançon, 25000, France

RECRUITING

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Central Study Contacts

Anne-Sophie MARIET

CONTACT

03.80.29.55.74anne-sophie.mariet@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 24, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

FR(2)