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NCT05305261 Clinical Trial

Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.

Vaccine Clinical Trial

Official title:
Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05305261
Other study ID # FF-2021-362
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 29, 2021
Est. completion date March 18, 2022

Study information
Verified date March 2022
Source National University of Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.

Description:

Covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. The introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. Channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. The efficacy of vaccination for the pregnant lady has been established. However, fetus protection via transmission of the antibody during pregnancy is still uncertain. Therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date March 18, 2022
Est. primary completion date March 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - term pregnancies at 37 weeks or more - vaccinated 2 doses - in labour Exclusion Criteria: - unvaccinated - preterm labour less than 37 weeks - multiple pregnancies

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Malaysia UKM Medical Center Kuala Lumpur W.Persekutuan

Sponsors (2)
Lead Sponsor Collaborator
National University of Malaysia Malaysia Automotive Robotics and Innovation of Technology Institute

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19 Quantification of Covid-19 antibody levels in maternal and cord blood samples 30 minutes after delivery
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