NCT03651843

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

August 1, 2018

Last Update Submit

October 7, 2019

Conditions

Keywords

high riskpregnant womenoccupational hazardoccupational risk

Outcome Measures

Primary Outcomes (1)

  • percentage of women who thought they had occupational exposures at risk for their baby during pregnancy

    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 Outcomes (2)

  • adaptation or not of the workstation in case of exposure to a professional risk

    at childbirth

  • percentage of women with a score of at least 5 out of 10

    at childbirth

Study Arms (1)

Healthy subjects

Other: Questionnaire

Interventions

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.

Also known as: Occupational risk exposure questionnaire during pregnancy
Healthy subjects

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sophie Fantoni, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 29, 2018

Study Start

September 4, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations