Pregnancy, High RiskPERISTRAGNCT03651843
Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
An observational study of Pregnancy, High Risk, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk
- What is being tested?
- Questionnaire
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2018to 30 Nov 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who have just given birth in maternity hospitals in the Lille metropolis and who worked during their pregnancy
Who may be able to join
- 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
Who cannot join
- minor women
- unemployed
- student
- guardianship
- work abroad
- change of employer during pregnancy
- inability to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pregnancy, High Risk
- Being tested
- Questionnaire
- Keywords
- high risk, pregnant women, occupational hazard, occupational risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Occupational risk exposure questionnaire during pregnancy
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At childbirth
Secondary outcomes (2)
adaptation or not of the workstation in case of exposure to a professional risk
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
Measured: at childbirth
percentage of women with a score of at least 5 out of 10
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)
Measured: at childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start4 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Fantoni, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651843
- Sponsor's protocol ID
- 2017_88
- Other IDs
- 2018-A00962-53
- Acronym
- PERISTRAG
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
- ClinicalTrials.gov ID
- NCT03651843
- Acronym / sponsor ID
- PERISTRAG / 2017_88
- Conditions
- Pregnancy, High Risk
- Keywords
- high risk, pregnant women, occupational hazard, occupational risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 29 Aug 2018 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have just given birth in maternity hospitals in the Lille metropolis and who worked during their pregnancy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- minor women
- unemployed
- student
- guardianship
- work abroad
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Occupational risk exposure questionnaire during pregnancyWomen 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 | Healthy subjects |
Primary outcome
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.
2 secondary outcomes
adaptation or not of the workstation in case of exposure to a professional risk
Time frame: at childbirth
percentage of women with a score of at least 5 out of 10
Time frame: at childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
Sophie Fantoni, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, High Risk, run by University Hospital, Lille at 1 site 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of women who thought they had occupational exposures at risk for their baby during pregnancy (time frame: At childbirth). 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 9 Oct 2019.