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

March 30, 2022 updated by: Rahana Abd Rahman, National University of Malaysia

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

197

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

  • Malaysia
    • W.Persekutuan
      • Kuala Lumpur, W.Persekutuan, Malaysia, 56000
        • UKM Medical Center

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All vaccinated pregnant women at term with or without a history of covid-19 infection admitted in labour

Description

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 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
Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
Time Frame: 30 minutes after delivery
Quantification of Covid-19 antibody levels in maternal and cord blood samples
30 minutes after delivery

Collaborators and Investigators

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

Sponsor

National University of Malaysia

Collaborators

Malaysia Automotive Robotics and Innovation of Technology Institute

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)

July 29, 2021

Primary Completion (Actual)

March 18, 2022

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2021-362

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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