COVID-19 on Placental Gene Expression and Pathology (PROSPER)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Positive for SARS-CoV-2 infection

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Upstate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The target population for the present study includes all women delivering at Greenville Memorial Hospital. The opportunity for enrollment may be extended to women that deliver at Greenville Memorial even if they conducted prenatal care outside of the Prisma OB/GYN Center if they meet the eligibility. We aim to recruit 40 patients for analysis. Additionally, 60 samples will be recruited from women delivering at NorthShore Health System who test positive for COVID-19 during pregnancy.

Description

Inclusion Criteria:

1. COVID-19 infection during pregnancy, including at time of delivery
2. Age >=18 years
3. ≥13 6/7 weeks' GA

Exclusion Criteria:

1. Known major fetal chromosomal abnormality
2. Other major infection during pregnancy (specifically influenza A or B, cytomegalovirus, toxoplasma, rubella, syphilis, HIV)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Cases); 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; Patients that have a positive test for SARS-CoV-2 infection during pregnancy, including at the time of delivery.
Group 2 (Control); Historic group of patients delivering prior to the COVID-19 pandemic.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Jessica Britt, PhD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00101090

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No