CClinicalTrials.gg
Status unknownNCT03283189PERICOSUpdated Feb 4, 2019

Cosmetics and Pregnancy

An observational study in Pregnancy, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy

Keywords

  • Use of cosmetics
  • Pregnant women
  • Risk perception
  • Preventive attitude
  • Qualitative study
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

pregnant women

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

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.).
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • Group 5

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

    Other: Group discussions

  • Group 6

    Liberal follow-up of pregnancy

Interventions

  • OtherGroup 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at day 1 (during the interview)

Secondary outcomes

  1. 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.

    Time frame: at day 1 (during the interview)

  2. 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

    Time frame: at day 1 (during the interview)

06

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    • Patrick LACARIN · Contact · placarin@chu-clermontferrand.fr · 04 73 75 11 95
    • Cécile MARIE · Principal investigator
    • Françoise VENDITELLI · Sub investigator
    • Marie-Pierre SAUVANT-ROCHAT · Sub investigator
    • Marie-Reine FRADET · Sub investigator
    • Marie-Paule CELSE · Sub investigator
    • Bonnie DELEPINE · Sub investigator
07

Registry details

Key details

Study ID
NCT03283189
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Agence Régionale de Santé Rhône-Alpes, Université d'Auvergne, Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Feb 28, 2019 (estimated)
Primary completion
Dec 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Feb 4, 2019

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
04 73 75 11 95
Cécile MARIE
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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