Official Title
Risks of COVID19 in the Pregnant Population
Brief Summary

It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.

Detailed Description

The objectives are to understand the prevalence of maternal fetal transmission, risk factors
and outcomes of a COVID19 positive pregnancy, and how the virus can be passed from mother to
infant in the pregnant population at Mayo Clinic Rochester MN. Assessments will include the
viral detection and viral load in maternal and fetal specimens collected from COVID19
positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and
tissues, anti-COVID IgG and IgM in maternal and neonatal blood, viral load and viral antigens
in maternal and fetal specimens. placental gross and histopathologic changes in COVID19
infected mothers, stratified by gestational age and disease severity, compared to control
samples.

.

Completed
COVID19

Other: Biospecimen collection

Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.
Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

Eligibility Criteria

Inclusion Criteria:

- Pregnant women ages 18 - 45 years of age and their newborn infants

- Willing and able to provide written informed consent

- Planning to deliver at Mayo Clinic in Rochester, MN

Exclusion Criteria:

- Positive for HIV, HBV, or TB

- Delivery does not occur at Mayo Clinic

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 45 Years
Countries
United States
Locations

Mayo Clinic Rochester
Rochester, Minnesota, United States

Regan N Theiler, MD, PhD, Principal Investigator
Mayo Clinic

NCT Number
Keywords
COVID19
Coronavirus
pregnancy
Viral Infection
MeSH Terms
COVID-19