Cosmetics and Pregnancy

• Conditions: Pregnancy
• Interventions: Other: Group discussions

• Registration Number: NCT03283189
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Study Start: 2019-02-28
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Group discussions	Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)
Group 3	Group discussions	Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)
Group 4	Group discussions	Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)
Group 5	Group discussions	Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour)
Group 1	Group discussions	Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)

Primary Outcome Measures

Name	Time	Method
Pregnant women's views on the risk related to the use of cosmetics	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.

Secondary Outcome Measures

Name	Time	Method
Cosmetic's use during pregnancy	at day 1 (during the interview)	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.
Expectations of pregnant women in terms of information about the use of cosmetics	at day 1 (during the interview)	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France