Clinical trial NCT03283189: Cosmetics and Pregnancy
Official title: Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Use of cosmetics
Pregnant women
Risk perception
Preventive attitude
Qualitative study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé Rhône-Alpes
name: Université d'Auvergne
name: Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)
First posted: 2017-09-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief 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. 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Pregnant women's views on the risk related to the use of cosmetics
timeFrame: at day 1 (during the interview)
Secondary outcomes:
measure: Cosmetic's use during pregnancy
timeFrame: at day 1 (during the interview)
measure: Expectations of pregnant women in terms of information about the use of cosmetics
timeFrame: at day 1 (during the interview)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Cécile MARIE
role: PRINCIPAL_INVESTIGATOR
References: