Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.

February 13, 2024 updated by: Vachira Phuket Hospital

Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Montree Boonyakitanon, M.D.
  • Phone Number: +66895005657
  • Email: Mon_135@yahoo.com

Study Locations

  • Thailand
      • Phuket, Thailand, 83000
        • Recruiting
        • Vachira Phuket Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Montree Boonyakitanon, M.D.
        • Sub-Investigator:
          • Ratikorn Saejong, M.D.

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Thai term pregnant women
  • 18-45 year old
  • At least 1 covid vaccination received
  • admission at Vachira Phuket Hospital Labor Room

Exclusion Criteria:

  • Do not want to participate
  • Unstable or Emergency condition

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Thai term pregnant woman who have at least One dose of Covid vaccination
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)
Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level
Time Frame: 1 month
Test for correlation of level in maternal and cord blood
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysed time effect from last vaccination and type.
Time Frame: 1 month
Test for time effect after last dose of vaccination
1 month

Collaborators and Investigators

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

Sponsor

Vachira Phuket Hospital

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)

October 25, 2023

Primary Completion (Estimated)

November 25, 2024

Study Completion (Estimated)

December 25, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VPH REC 009/2023

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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