COVID-19 on Placental Gene Expression and Pathology

Study Overview
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Brief Summary
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Little is known regarding the effect of antenatal COVID-19 on pregnancy outcomes. The purpose of this study is to determine of COVID-19 alters histopathology and gene expression of the placenta, as evidenced by analysis at time of delivery. The analysis will aim to identify whether resulting abnormal placental pathology or altered metabolism is associated with severity of symptoms (specifically pneumonia, or need for admission), gestational age at onset, and/or placenta efficiency. Histological and gene expression analysis of the placental post-delivery will determine if COVID-19 alters overall placental structure, vascularization, and/or the transcriptome.

Official Title
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Pregnancy Outcomes During the Pandemic: Using Placental Pathology and Gene Expression to Understand Fetal Risk

Conditions
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COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Positive for SARS-CoV-2 infection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 infection during pregnancy, including at time of delivery Age >=18 years ≥13 6/7 weeks' GA Exclusion Criteria: Known major fetal chromosomal abnormality Other major infection during pregnancy (specifically influenza A or B, cytomegalovirus, toxoplasma, rubella, syphilis, HIV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (Cases)<br>Patients that test positive for SARS-CoV-2 infection during pregnancy, including at the time of delivery. | Diagnostic Test: Positive for SARS-CoV-2 infection<br>* Patients that have a positive test for SARS-CoV-2 infection during pregnancy, including at the time of delivery.<br>|
| Group 2 (Control)<br>Historic group of patients delivering prior to the COVID-19 pandemic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory biomarkers in umbilical cord blood between women with COVID-19 disease in the first, second and third trimester of pregnancy and determine if differences are mediated by severity of the illness. | Umbilical cord blood will be analyzed using an inflammatory biomarker panel (TNF, IL6, CRP, IL4, IL13) | At the time of delivery. | 
| Differences in placental pathology (inflammatory processes, vasculopathy, and villous maturity) for women with COVID-19 disease and determine of differences are mediated by gestational age at infection or severity of illness. | A perinatal pathologist will review placental pathology findings to determine the occurrence of inflammatory processes, vasculopathy, and villous maturity, as reflected in histology. | At the time of delivery. | 
| Differences in gene expression analysis for women with COVID-19 disease and determine if differences are medicated by gestational age at infection or severity of illness. | Gene expression analysis will be conducted to identify altered gene expression patterns related to placental development (inflammation, vascularity, and metabolism). | At the time of delivery. |