COVID-19 on Placental Gene Expression and Pathology

COVID-19 Clinical Trial

— PROSPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585945
• Other study ID #: Pro00101090
• Status: Completed
• Start date: August 4, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 28, 2022
• Est. primary completion date: April 21, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Prisma Health Upstate	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.