Mother - Newborn Observational Study

February 8, 2024 updated by: Ulrike Blume-Peytavi, MD, Charite University, Berlin, Germany

Skin Structure, Skin Function and Skin Microbiome of Pregnant Females and Their Newborns: a Descriptive Longitudinal Study

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 in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular water-holding and transport mechanisms are very different to adults in the first year in life. The most important open question is whether and how the maternal cutaneous properties predict the skin function of their children. This is especially relevant for the skin microbiome, because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the objective of this study is the description of characteristics of skin and hair structure and skin function of pregnant women and their newborns during pregnancy and for both in the first six months after delivery. In addition, we investigate associations of the mother's and their newborns skin microbiomes, and changes thereof in the newborns within the first six months of life.

The study has a descriptive, exploratory, longitudinal design. We will recruit pregnant females between 18 to 45 years old using advertisement campaigns, study information material in the waiting areas of their gynecologists, in pregnancy preparation services and in hospital's outpatient services. If they are interested and fulfill the inclusion criteria, they are invited to participate. Taking into account an assumed dropout rate of about 30%, a final sample of n = 100 women is expected. A detailed dermatological examination and general medical condition are documented. Non-invasive, standardized skin and hair physiological and skin microbiome measurements are performed during the visits. Baseline is scheduled during pregnancy until late 4 weeks before delivery. Follow-up visits are scheduled 4 weeks and 6 months after birth for mothers and newborns. Descriptive statistical methods will be calculated for frequencies and associations over time depending on scale levels of the measurements.

In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over the period of at least 8 months. Considering these multiple variables and levels together will allow a deeper understanding of the complex interrelationship of the newborns skin maturation.

Study Overview

Status

Completed

Conditions

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 first pregnancy trimester from the federal state of Berlin (Germany) during their visits to gynecologists and/or midwives. Inclusion and all study visits and measurement procedures will be conducted at the Clinical Research Center for Hair and Skin Science at the Department of Dermatology at the Charité-Universitätsmedizin Berlin (Germany). If meeting the eligibility criteria women will be included into the study. After inclusion into the study during the baseline visit, women will be followed at date of delivery + four weeks and followed further at the sixth month after delivery. The newborn/infants will be examined up to four weeks after birth and will be followed at sixth month after birth.

Due to the descriptive and exploratory nature of this study a broad range of characteristics and variables will be measured. Main aspects are skin structure, skin function and skin microbiome in one skin area. Skin structure will be measured by means of skin surface topography, epidermal thickness, skin stiffness and elasticity. Skin function will be measured by means of stratum corneum hydratation (SCH), TEWL and skin surface pH, which are established parameters to characterize the skin barrier function. Skin microbiome is defined as bacterial diversity, in detail the relative abundance of phylotypes, operational taxonomic units (OTU) will be measured. Hair growth will be measured on central and occipital scalp by means of hair density, hair widths.

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite-Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Pregnant women and their newborns

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
measurement of skin hydration: arbitrary units 0-120 , whereas higher readings indicate higher stratum corneum hydration
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin surface pH at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Skin pH-meter measurement (range from 4 to 7,5)
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Transepidermal water loss (TEWL ) at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Transepidermal waterloss through the stratum corneum in g per hour per m2 (range: 0,0-60,0 g/m2/h)
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin stiffness and elasticity at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
total extensibility (Uf, mm), Structural elasticity Uf) of the skin (0,00-0,50 Uf in mm/degree)
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Epidermal thickness at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Standardized images via Optical coherence tomography (OCT) measured in mm
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin surface topography at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

Standardized images via Visioscan

  • RA (arithmetic mean roughness) in µm
  • RZ (arithmetic mean roughness from five sampling length) in µm
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin microbiome at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Bacterial diversity Relative abundance of phylotypes (operational taxonomic units, (OTUs)
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Hair growth at 4 weeks and 6 months after delivery
Time Frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Measurement of Hair thickness
baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Ulrike Blume-Peytavi, Prof. MD, Charité Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

September 26, 2023

Study Completion (Actual)

September 26, 2023

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRC-SP-AC-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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