NCT03283189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

September 8, 2017

Last Update Submit

February 1, 2019

Conditions

Keywords

Use of cosmeticsPregnant womenRisk perceptionPreventive attitudeQualitative study

Outcome Measures

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.

    at day 1 (during the interview)

Secondary Outcomes (2)

  • Cosmetic's use during pregnancy

    at day 1 (during the interview)

  • Expectations of pregnant women in terms of information about the use of cosmetics

    at day 1 (during the interview)

Study Arms (6)

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

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 1Group 2Group 3Group 4Group 5

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Cécile MARIE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 14, 2017

Study Start

February 28, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations