NCT04813887

Brief Summary

Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash. These pathological rashes can be dangerous for the mother or the fetus. The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

September 9, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

March 19, 2021

Last Update Submit

September 8, 2021

Conditions

Skin AbnormalitiesPregnancy

Outcome Measures

Primary Outcomes (1)

  • Identify the health care provider that pregnant women consult when experiencing a skin disease

    Type of health care provider seeing a pregnant woman for skin disease

    after delivery during the patient's stay in the maternity (2-3 days)

Interventions

questionnaireOTHER

Self-questionnaire on skin diseases reported during pregnancy

Eligibility Criteria

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

Prospective collection of data from a questionnaire answered by patients giving birth at the Departmental Hospital Center of Vendee during the postpartum period.

You may qualify if:

  • Any woman who gives birth at Departmental Hospital Center of Vendee

You may not qualify if:

  • Patient's refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Conditions

Skin Abnormalities

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guillaume DUCARME

    Departmental Hospital Center of Vendee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 24, 2021

Study Start

April 7, 2021

Primary Completion

April 7, 2021

Study Completion

August 10, 2021

Last Updated

September 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)