AntibodyNCT05305261
Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.
An observational study of Antibody and Vaccine, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- How many people
- 197 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 Jul 2021to 18 Mar 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All vaccinated pregnant women at term with or without a history of covid-19 infection admitted in labour
Who may be able to join
- term pregnancies at 37 weeks or more
- vaccinated 2 doses
- in labour
Who cannot join
- unvaccinated
- preterm labour less than 37 weeks
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Covid-19, antibody, pregnancy
- Medical subject headings
- Cone-Rod Dystrophies, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
Quantification of Covid-19 antibody levels in maternal and cord blood samples
Measured: 30 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start29 Jul 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Automotive Robotics and Innovation of Technology Institute
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305261
- Sponsor's protocol ID
- FF-2021-362
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
- ClinicalTrials.gov ID
- NCT05305261
- Acronym / sponsor ID
- FF-2021-362
- Keywords
- Covid-19, antibody, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Automotive Robotics and Innovation of Technology Institute
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All vaccinated pregnant women at term with or without a history of covid-19 infection admitted in labour
Key inclusion criteria (3 listed)
- term pregnancies at 37 weeks or more
- vaccinated 2 doses
- in labour
Key exclusion criteria (3 listed)
- unvaccinated
- preterm labour less than 37 weeks
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody and Vaccine, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19 (time frame: 30 minutes after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.