Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04732767 |
| Other study ID # |
08-20-20E |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 patient's medical
record. Data will be collected into a Redcap database by research personnel. Neonatal data
will be obtained from the neonate's 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.
