NCT05305261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 29, 2022

Last Update Submit

March 30, 2022

Conditions

AntibodyVaccineMaternalCord

Keywords

Covid-19antibodypregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • term pregnancies at 37 weeks or more
  • vaccinated 2 doses
  • in labour

You may not qualify if:

  • unvaccinated
  • preterm labour less than 37 weeks
  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKM Medical Center

Kuala Lumpur, W.Persekutuan, 56000, Malaysia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal and cord blood samples taken to measure the antibody levels for Covid-19 at delivery.

MeSH Terms

Conditions

Cone-Rod DystrophiesCOVID-19

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2022

First Posted

March 31, 2022

Study Start

July 29, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)