Status:
COMPLETED
Mother - Newborn Observational Study
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Skin Microbiome
Eligibility:
FEMALE
18-45 years
Brief Summary
Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children i...
Detailed Description
A longitudinal descriptive, exploratory cohort study will be performed including females during pregnancy, puerperium and their newborns until sixth months of life. Women will be invited after the fi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- written informed consent
- clinically healthy skin and hair appearance
- being free of any dermatological condition
- acceptance to abstain from sunbathing
- acceptance to abstain from solarium
- agreement to use the same skin cleaning and caring procedures during the study
- Exclusion Criteria:
- regular smoking
- regular alcohol intake
- any dermatological condition or skin affection which may interfere with the study assessments (psoriasis, atopic dermatitis or other lesions at the investigational sites)
- clinically significant, possibly unstable medical conditions due to gravidity such as gestosis, eclampsia or thrombosis.
- Criteria related to treatments and products such as current topical or systemic treatment possibly affecting the skin, (diuretics, cholesterol-lowering drugs, hormones) during past four weeks
- therapeutic ultraviolet radiation within six weeks before inclusion
- increased ultraviolet-exposure within six weeks before inclusion
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04759924
Start Date
March 1 2021
End Date
September 26 2023
Last Update
February 9 2024
Active Locations (1)
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1
Charité-Universitätsmedizin Berlin
Berlin, Germany, 10117