Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732767
Status:
WITHDRAWN
Last Update Posted:
2022-04-25
First Post:
2021-01-28
Brief Title:
Evaluation of COVID-19 IgG Antibodies in Maternal and Cord Blood Samples
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Prospective Study of Maternal and Umbilical Cord Blood Collection to Evaluate for Presence of COVID-19 Antibody Response in COVID-19 Positive Women
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough research personnel to complete study at the time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
InclusionExclusion 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 PUICOVID-19 positive women
Statistical Analysis Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings
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
InclusionExclusion 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 PUICOVID-19 positive women
Statistical Analysis Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings
Detailed Description:
Background
The clinical syndrome of coronavirus 2019 COVID-19 caused by the severe acute respiratory 2 virus SARS-CoV-2 first began in Wuhan China in December 2019 and subsequently spread globally at an exponential rate The disease was officially classified by the World Health Organization as a pandemic on March 11 2020 The first death from COVID-19 was reported in the United States on February 28 2020
In general pregnancy is a state of relative immunosuppression and alterations in immunology and physiology during pregnancy increase the risks of significant respiratory complications and associated obstetrical complications from severe illness To date data to guide understanding of the impact of COVID-19 on pregnancy is relatively limited With any viral illness in pregnancy there is potential for maternal-fetal transmission As of now there have been very few reported cases of suspected vertical transmission Moreover there have been few cases of neonatal transmission even in patients acutely ill with COVID-19 at the time of delivery However a recent case report highlighted a 19 week pregnancy loss in a COVID-19 positive patient where placenta pathology showed presence of COVID-19 by PCR although fetal samples were negative
As the United States begins to expand testing from viral to antibody testing opportunity exists to determine if maternal antibodies are present in neonates If present these antibodies may confer protection for neonates born to infected mothers During the course of any infection IgM antibodies are formed with subsequent development of IgG antibodies Regardless of source maternal IgM antibodies do not readily cross the placenta barrier while maternal IgG antibodies easily cross the placenta during pregnancy Fetuses are capable of initiating an IgM response to infection in utero Cord blood serves as a non-invasive source of neonatal blood that can be easily obtained at delivery and allows assessment of the neonate
Hypothesis
We hypothesize that cord blood collected from COVID-19 positive women will show presence of IgG antibodies against COVID-19 which may confer protection for the infant in the neonatal period
Objective
To collect 1 maternal blood samples for COVID-19 IgG antibodies on admission to labor and delivery 2 cord blood samples for COVID-19 IgG antibodies at the time of delivery 3 placenta pathology
Study Type
Prospective cohort study of pregnant COVID-19 positive patients at delivery admission or at any point during the pregnancy
Study Methods
Eligible patients will be invited to participate in the study during pregnancy or on admission to labor and delivery Eligible patients will have had a positive COVID-19 PCR test at some time during pregnancy or on the delivery admission Informed consent will be obtained by admitting physician from patients who agree to participate A maternal blood sample will be obtained with routine admission labs by nursing staff This sample will be sent for immunoassay for qualitative assessment for COVID-19 IgG antibodies C-reactive protein will also be measured as this is an indicator of severe disease At delivery cord blood and placenta samples will be obtained as per routine collection methods by the delivery physician Cord blood will be sent for the same analysis as the maternal blood sample The placenta will be sent to pathology Results will be obtained through the patients medical record Data will be collected into a Redcap database by research personnel Neonatal data will be obtained from the neonates medical record and entered into the Redcap database by research personnel Any publications resulting from this study will use de-identified patient data
The benefit of this study will be contribution to the limited data that exists around COVID-19 infection and pregnancy
Data Analysis
Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings
The clinical syndrome of coronavirus 2019 COVID-19 caused by the severe acute respiratory 2 virus SARS-CoV-2 first began in Wuhan China in December 2019 and subsequently spread globally at an exponential rate The disease was officially classified by the World Health Organization as a pandemic on March 11 2020 The first death from COVID-19 was reported in the United States on February 28 2020
In general pregnancy is a state of relative immunosuppression and alterations in immunology and physiology during pregnancy increase the risks of significant respiratory complications and associated obstetrical complications from severe illness To date data to guide understanding of the impact of COVID-19 on pregnancy is relatively limited With any viral illness in pregnancy there is potential for maternal-fetal transmission As of now there have been very few reported cases of suspected vertical transmission Moreover there have been few cases of neonatal transmission even in patients acutely ill with COVID-19 at the time of delivery However a recent case report highlighted a 19 week pregnancy loss in a COVID-19 positive patient where placenta pathology showed presence of COVID-19 by PCR although fetal samples were negative
As the United States begins to expand testing from viral to antibody testing opportunity exists to determine if maternal antibodies are present in neonates If present these antibodies may confer protection for neonates born to infected mothers During the course of any infection IgM antibodies are formed with subsequent development of IgG antibodies Regardless of source maternal IgM antibodies do not readily cross the placenta barrier while maternal IgG antibodies easily cross the placenta during pregnancy Fetuses are capable of initiating an IgM response to infection in utero Cord blood serves as a non-invasive source of neonatal blood that can be easily obtained at delivery and allows assessment of the neonate
Hypothesis
We hypothesize that cord blood collected from COVID-19 positive women will show presence of IgG antibodies against COVID-19 which may confer protection for the infant in the neonatal period
Objective
To collect 1 maternal blood samples for COVID-19 IgG antibodies on admission to labor and delivery 2 cord blood samples for COVID-19 IgG antibodies at the time of delivery 3 placenta pathology
Study Type
Prospective cohort study of pregnant COVID-19 positive patients at delivery admission or at any point during the pregnancy
Study Methods
Eligible patients will be invited to participate in the study during pregnancy or on admission to labor and delivery Eligible patients will have had a positive COVID-19 PCR test at some time during pregnancy or on the delivery admission Informed consent will be obtained by admitting physician from patients who agree to participate A maternal blood sample will be obtained with routine admission labs by nursing staff This sample will be sent for immunoassay for qualitative assessment for COVID-19 IgG antibodies C-reactive protein will also be measured as this is an indicator of severe disease At delivery cord blood and placenta samples will be obtained as per routine collection methods by the delivery physician Cord blood will be sent for the same analysis as the maternal blood sample The placenta will be sent to pathology Results will be obtained through the patients medical record Data will be collected into a Redcap database by research personnel Neonatal data will be obtained from the neonates medical record and entered into the Redcap database by research personnel Any publications resulting from this study will use de-identified patient data
The benefit of this study will be contribution to the limited data that exists around COVID-19 infection and pregnancy
Data Analysis
Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None