Risks of COVID19 in the Pregnant Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Determine the prevalence of maternal fetal transmission of COVID19
Study Overview
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.
.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Determine the prevalence of maternal fetal transmission of COVID19
Time Frame: 12 months
Standardized testing of maternal, placental, and neonatal specimens will be used to determine presence of current infection with SARS-CoV2. Clinical RT-PCR assays will be used to determine the presence of viral RNA in all specimens.
Secondary Outcomes
- Describe the outcomes of COVID19 positive pregnancies(12 months)
- Understand the placental impact of COVID19 in pregnancy at various gestational ages(12 months)
Investigators
Regan N. Theiler
Principal Investigator
Mayo Clinic