Cosmetics and Pregnancy

NCT ID: NCT03283189

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-12-30

Brief Summary

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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

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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

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Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)

Group discussions

Intervention Type OTHER

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.

Group 2

Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)

Group discussions

Intervention Type OTHER

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.

Group 3

Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)

Group discussions

Intervention Type OTHER

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.

Group 4

Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)

Group discussions

Intervention Type OTHER

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.

Group 5

Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour)

Group discussions

Intervention Type OTHER

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.

Group 6

Liberal follow-up of pregnancy

No interventions assigned to this group

Interventions

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Group discussions

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- 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.

Exclusion Criteria

* 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.).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agence Régionale de Santé Rhône-Alpes

OTHER

Sponsor Role collaborator

Université d'Auvergne

OTHER

Sponsor Role collaborator

Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile MARIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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CHU-350

Identifier Type: -

Identifier Source: org_study_id

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