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Evaluation of COVID-19 IgG Antibodies in Maternal and Cord Blood Samples

NCT04732767 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-04-25

No results posted yet for this study

Summary

Protocol Summary

Study design: Prospective cohort study of pregnant COVID-19 positive patients at delivery.

Study Objective: To collect umbilical cord blood and placenta samples at the time of delivery in COVID-19 positive women and evaluate for presence of COVID-19 virus and maternal antibody response.

Inclusion/Exclusion Criteria: Women admitted for delivery who are known or suspected COVID-19 positive who have had standard nasal swab testing for COVID-19.

Study Procedures: Informed consent for patients will be obtained. Maternal blood will be collected for viral and antibody tests for COVID-19. Following delivery of the neonate, cord blood and placenta samples will be collected and sent for viral PCR and maternal antibody analysis. Neonatal testing will be done as per existing clinical protocol for infants born to PUI/COVID-19 positive women.

Statistical Analysis: Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings.

Conditions

  • Covid19
  • Pregnancy Related
  • Antibody Response

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ngina K Connors, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2021-06-30
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732767 on ClinicalTrials.gov