COVID-19 on Placental Gene Expression and Pathology

NCT04585945 | Completed

• 1 other identifier: Pro00101090
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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

Group 2 (Control)

Historic group of patients delivering prior to the COVID-19 pandemic.

Interventions

Positive for SARS-CoV-2 infection DIAGNOSTIC_TEST

Patients that have a positive test for SARS-CoV-2 infection during pregnancy, including at the time of delivery.

Group 1 (Cases)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. A total of 40 patients will be recruited for analysis. Additionally, 60 samples will be recruited from women delivering at NorthShore Health System who test positive for COVID-19 during pregnancy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placental specimens for transcriptomic analysis.

MeSH Terms

Conditions

COVID-19

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Jessica Britt, PhD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 14, 2020
• Study Start: August 4, 2020
• Primary Completion: April 21, 2021
• Study Completion: February 28, 2022
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)