PregnancyPERICOSNCT03283189
Cosmetics and Pregnancy
An observational study of Pregnancy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Group discussions
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to 30 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women
Who may be able to join
- - Pregnant women between 22 (≥ 22 weeks) et ≤ 39 weeks of gestation;
- Obstetric management in the Réseau de Santé en Périnatalité d'Auvergne (RSPA);
- At least 18 years;
- Understanding and speaking French;
- And giving their signed agreement of participation.
Who cannot join
- Refusal to participate or to be registered during the collective interview;
- Women with fetal death in utero or whose fetus or fetuses have a malformation;
- Women with psychiatric disorders, mental confusion or language disorders making impossible the interview;
- Women with chronic dermatological pathology requiring dermatological care (eczema, psoriasis, etc.).
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Cécile MARIE
About this study
Official title: Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study
The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. However, the perception and the use of cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant women.
Understanding the risk perception, the knowledge, attitudes and expectations of women about the use of cosmetics during pregnancy will help to set up effective strategies to improve prevention of chemical exposure.
Read the detailed description
A qualitative study of 60 pregnant women using six focus groups (9-11 pregnant women per group) was implemented study in Auvergne Region, France. Six focus groups will be conducted until data saturation.
The women will be recruited from the Clermont-Ferrand University Hospital (maternity type III - 2 groups), the private clinic in Beaumont (maternity type II - 2 groups), the Saint-Flour hospital center (maternity type I - 1 group), and from liberal health professionals (1 group).
If a women is found to be eligible, she will be invited to participate in the study. The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid.
All interviews will be audio-recorded, transcribed, coded and computerized for analysis with the NVIVO v11 software.
- Conditions
- Pregnancy
- Being tested
- Group discussions
- Keywords
- Use of cosmetics, Pregnant women, Risk perception, Preventive attitude, Qualitative study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group discussionsOther
The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid. All interviews will be audio-recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand) Receives: Other: Group discussions | |
| Group 2 | Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand) Receives: Other: Group discussions | |
| Group 3 | Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand) Receives: Other: Group discussions | |
| Group 4 | Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand) Receives: Other: Group discussions | |
| Group 5 | Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour) Receives: Other: Group discussions | |
| Group 6 | Liberal follow-up of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnant women's views on the risk related to the use of cosmetics
the perception of the risks linked to the use of cosmetics in general, and creams for striae gravidarum in particular, were investigated during the focus groups interviews.
Measured: at day 1 (during the interview)
Secondary outcomes (2)
Cosmetic's use during pregnancy
How cosmetics (all cosmetics and creams for striae gravidarum) are used and modifications in the behavior of pregnant women (decrease of use, choice of other products, etc.). Investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview.
Measured: at day 1 (during the interview)
Expectations of pregnant women in terms of information about the use of cosmetics
needs and expectations of pregnant women in terms of information support and advice about the use of cosmetics were investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview
Measured: at day 1 (during the interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start28 Feb 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes, Université d'Auvergne, Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)
- Responsible party
- Sponsor
- Investigators
- Cécile MARIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283189
- Sponsor's protocol ID
- CHU-350
- Acronym
- PERICOS
- Status last verified
- Feb 2019
- First submitted
- 8 Sep 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study
- ClinicalTrials.gov ID
- NCT03283189
- Acronym / sponsor ID
- PERICOS / CHU-350
- Conditions
- Pregnancy
- Keywords
- Use of cosmetics, Pregnant women, Risk perception, Preventive attitude, Qualitative study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes, Université d'Auvergne, Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)
- Study start
- 28 Feb 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 14 Sep 2017 (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.
The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. However, the perception and the use of cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant women.
Understanding the risk perception, the knowledge, attitudes and expectations of women about the use of cosmetics during pregnancy will help to set up effective strategies to improve prevention of chemical exposure.
Detailed description
A qualitative study of 60 pregnant women using six focus groups (9-11 pregnant women per group) was implemented study in Auvergne Region, France. Six focus groups will be conducted until data saturation.
The women will be recruited from the Clermont-Ferrand University Hospital (maternity type III - 2 groups), the private clinic in Beaumont (maternity type II - 2 groups), the Saint-Flour hospital center (maternity type I - 1 group), and from liberal health professionals (1 group).
If a women is found to be eligible, she will be invited to participate in the study. The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid.
All interviews will be audio-recorded, transcribed, coded and computerized for analysis with the NVIVO v11 software.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Group discussionsPregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand) |
| Group 2 | – | Other: Group discussionsPregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand) |
| Group 3 | – | Other: Group discussionsPregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand) |
| Group 4 | – | Other: Group discussionsPregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand) |
| Group 5 | – | Other: Group discussionsPregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour) |
| Group 6 | – | –Liberal follow-up of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (5 listed)
- - Pregnant women between 22 (≥ 22 weeks) et ≤ 39 weeks of gestation;
- Obstetric management in the Réseau de Santé en Périnatalité d'Auvergne (RSPA);
- At least 18 years;
- Understanding and speaking French;
- And giving their signed agreement of participation.
Key exclusion criteria (4 listed)
- Refusal to participate or to be registered during the collective interview;
- Women with fetal death in utero or whose fetus or fetuses have a malformation;
- Women with psychiatric disorders, mental confusion or language disorders making impossible the interview;
- Women with chronic dermatological pathology requiring dermatological care (eczema, psoriasis, etc.).
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 |
|---|---|---|
| Group discussionsThe focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid. All interviews will be audio-recorded. | Other | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Pregnant women's views on the risk related to the use of cosmetics
Time frame: at day 1 (during the interview)
the perception of the risks linked to the use of cosmetics in general, and creams for striae gravidarum in particular, were investigated during the focus groups interviews.
2 secondary outcomes
Cosmetic's use during pregnancy
Time frame: at day 1 (during the interview)
Expectations of pregnant women in terms of information about the use of cosmetics
Time frame: at day 1 (during the interview)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
Cécile MARIE principal investigator
University Hospital, Clermont-Ferrand
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, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnant women's views on the risk related to the use of cosmetics (time frame: at day 1 (during the interview)). 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 4 Feb 2019.