Risks of COVID19 in the Pregnant Population

Study Overview
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Brief Summary
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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
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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. .

Official Title
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Risks of COVID19 in the Pregnant Population

Conditions
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COVID19

Intervention / Treatment
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* Other: Biospecimen collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women - positive COVID19 test<br>Pregnant women of any gestational age 8 weeks through delivery with a positive COVID19 test, with or without physical symptoms | Other: Biospecimen collection<br>* 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.<br>|
| Pregnant women - negative or unknown COVID19 test<br>Pregnant women experiencing any respiratory or other physical symptoms of COVID19 at onset of labor, with negative or uncertain COVID19 test results | Other: Biospecimen collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the prevalence of maternal fetal transmission of COVID19 | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the outcomes of COVID19 positive pregnancies | Clinical data from prenatal, intrapartum, and postpartum care will be abstracted from maternal records and correlated with neonatal outcomes. Any complications will be characterized, with comparison to the non-COVID19 control group of patients. Statistical analysis will reveal characteristics and clinical outcomes that may be linked to COVID19 infection in pregnancy. | 12 months | 
| Understand the placental impact of COVID19 in pregnancy at various gestational ages | In addition to maternal and fetal infection, disease states related to placental dysfunction may be related to COVID19 infection in pregnancy. We will examine placenta and markers of placental function to assess for discernable consequences of maternal infection. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Coronavirus, Pregnancy, Viral infection