Effect of Birth on Immunological Parameters in Cord Blood

The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

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Key information

Conditions

Immunologic Activity Alteration

Sex eligibility

Female

Study type

Observational

About this study

The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant mothers undergoing normal vaginal delivery

Exclusion criteria

Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth

Antenatal antibiotics treatment (2 weeks prior to birth)
Diabetes mellitus requiring insulin treatment during pregnancy
Uncontrollable Hyperthyroidism during pregnancy

Treatment and study plan

This is not an interventional study

Other

This is an observational study

Primary outcomes

Cytokines Profile in Cord Blood Plasma

Time frame: 1 year

Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa
Cord Blood Immunoglobulin Levels

Time frame: 1 year

Immunoglobulin levels will be measured in cord blood plasma
Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)

Time frame: 1 year

Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Registry information

Official study title

To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: May 1, 2017
Registry last updated: Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed