Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis (PERISTRAG)

October 7, 2019 updated by: University Hospital, Lille

In ten years, the labor force has grown by 1.4 million people according to French national institute for statistical and economic studies. This increase is partly due to the increased presence of women in the labor market. Thus, the majority of some 800,000 annual births come from working women. However, some women in professional activity may be exposed to occupational risks, which may have effects on the develop-ment of the fetus during pregnancy. France benefits from protective legislative measures against pregnant women. Recommendations already exist.

But with medical desertification, pregnant women may have more difficulty contacting their occupational doctor or treating physician and to access information about the risks to her work-related pregnancy.

It seems to us important to be able to better quantify the information needs of women in this problem.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

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

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHU

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who have just given birth in maternity hospitals in the Lille metropolis and who worked during their pregnancy

Description

Inclusion Criteria:

  • working during their pregnancy (at least 2 months, including the beginning of pregnancy
  • having given birth during the period of inclusion
  • in a hospital or clinic of Lille metropolis volunteer to participate in the study

Exclusion Criteria:

  • minor women
  • unemployed
  • student
  • guardianship
  • work abroad
  • change of employer during pregnancy
  • inability to answer the questionnaire

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
Intervention / Treatment
Healthy subjects
Other: Questionnaire
Women who have recently given birth in the Lille metropolitan area fill in a self-administered questionnaire asking them about their perception of occupational risk during pregnancy and their knowledge of their right to work during pregnancy.
Other Names:
  • Occupational risk exposure questionnaire during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of women who thought they had occupational exposures at risk for their baby during pregnancy
Time Frame: At childbirth
the different occupational exposures are listed. If the woman has been exposed and thinks it's dangerous for her baby, she reports it.
At childbirth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adaptation or not of the workstation in case of exposure to a professional risk
Time Frame: at childbirth
if the woman is exposed to a defined risk and her job has been set up to avoid this risk during pregnancy, she reports it
at childbirth
percentage of women with a score of at least 5 out of 10
Time Frame: at childbirth
knowledge of French legislation concerning the protection of pregnant women at work of current legislation referenced in a questionnaire that includes 10 binary questions. A score will be calculated by summing the answers (score out of 10)
at childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Sophie Fantoni, MD,PhD, University Hospital, Lille

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)

September 4, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017_88
  • 2018-A00962-53 (Other Identifier: ID-RCB number, ANSM)

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.

Clinical Trials on Pregnancy, High Risk

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe