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NCT06259656 Clinical Trial

Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.

Covid-19 Clinical Trial

Official title:
Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06259656
Other study ID # VPH REC 009/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2023
Est. completion date December 25, 2024

Study information
Verified date October 2023
Source Vachira Phuket Hospital
Contact Ratikorn Saejong, M.D.
Phone +66896698613
Email sratikorn.si@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.

Description:

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 25, 2024
Est. primary completion date November 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Thai term pregnant women - 18-45 year old - At least 1 covid vaccination received - admission at Vachira Phuket Hospital Labor Room Exclusion Criteria: - Do not want to participate - Unstable or Emergency condition

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)
Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

Locations
Country Name City State
Thailand Vachira Phuket Hospital Phuket

Sponsors (1)
Lead Sponsor Collaborator
Vachira Phuket Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level Test for correlation of level in maternal and cord blood 1 month
Secondary Analysed time effect from last vaccination and type. Test for time effect after last dose of vaccination 1 month
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