NCT06259656

Brief Summary

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable covid19

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

July 3, 2024

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

February 13, 2024

Last Update Submit

July 1, 2024

Conditions

Covid-19

Keywords

Anti SARs-CoVPregnancyCordbloodVaccine

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level

    Test for correlation of level in maternal and cord blood

    1 month

Secondary Outcomes (1)

  • Analysed time effect from last vaccination and type.

    1 month

Study Arms (1)

Thai term pregnant woman who have at least One dose of Covid vaccination

OTHER

Maternal and cord blood was collected to test COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

Diagnostic Test: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

Interventions

COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)DIAGNOSTIC_TEST

Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

Thai term pregnant woman who have at least One dose of Covid vaccination

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thai term pregnant women
  • year old
  • At least 1 covid vaccination received
  • admission at Vachira Phuket Hospital Labor Room

You may not qualify if:

  • Do not want to participate
  • Unstable or Emergency condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vachira Phuket Hospital

Phuket, 83000, Thailand

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Thai term pregnant women are recruited at labor room, after informed consent was done. Characteristic data (such as vaccination type and time) and Maternal Blood was collected then cord blood was collected after birth. All blood was sent to test Anti SARs CoV antibody level. Then all data and 80 test result will analyzed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 14, 2024

Study Start

October 25, 2023

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

July 3, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)