Cosmetics and Pregnancy

Pregnancy Clinical Trial

— PERICOS  

Official title:

Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03283189
• Other study ID #: CHU-350
• Status: Not yet recruiting
• Start date: February 28, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Agence Régionale de Santé Rhône-Alpes, Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA), Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at day 1 (during the interview)
Secondary	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.	at day 1 (during the interview)
Secondary	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	at day 1 (during the interview)