Cosmetics and Pregnancy (PERICOS)

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Other: Group discussions

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand
    • Principal Investigator: Cécile MARIE
    • Sub-Investigator: Françoise VENDITELLI
    • Sub-Investigator: Marie-Pierre SAUVANT-ROCHAT
    • Sub-Investigator: Marie-Reine FRADET
    • Sub-Investigator: Marie-Paule CELSE
    • Sub-Investigator: Bonnie DELEPINE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)	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.
Group 2; Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)	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.
Group 3; Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)	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.
Group 4; Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)	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.
Group 5; Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour)	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.
Group 6; Liberal follow-up of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Université d'Auvergne; Agence Régionale de Santé Rhône-Alpes; Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)
• Investigators: Principal Investigator: Cécile MARIE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Qualitative study; Risk perception; Pregnant women; Use of cosmetics; Preventive attitude
• Other Study ID Numbers: CHU-350

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No