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

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT05305261
Collaborator
Malaysia Automotive Robotics and Innovation of Technology Institute (Other)
197
Enrollment
1
Location
7.6
Actual Duration (Months)
25.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    197 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
    Actual Study Start Date :
    Jul 29, 2021
    Actual Primary Completion Date :
    Mar 18, 2022
    Actual Study Completion Date :
    Mar 18, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19 [30 minutes after delivery]

      Quantification of Covid-19 antibody levels in maternal and cord blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UKM Medical Center Kuala Lumpur W.Persekutuan Malaysia 56000

    Sponsors and Collaborators

    • National University of Malaysia
    • Malaysia Automotive Robotics and Innovation of Technology Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rahana Abd Rahman, Associate Professor, National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT05305261
    Other Study ID Numbers:
    • FF-2021-362
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rahana Abd Rahman, Associate Professor, National University of Malaysia
    Covid-19
    antibody
    pregnancy
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 8, 2022