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

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

Sponsors

Lead Sponsor: Prisma Health-Upstate

Source Prisma Health-Upstate
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.

Overall Status Recruiting
Start Date August 4, 2020
Completion Date September 30, 2021
Primary Completion Date March 31, 2021
Study Type Observational
Primary Outcome
Measure 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. 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. 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. At the time of delivery.
Enrollment 100
Condition
Intervention

Intervention Type: Biological

Intervention Name: SARS-CoV-2

Description: COVID-19 - the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Arm Group Label: Group 1 (Cases)

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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)

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
Jessica Britt, PhD Principal Investigator Prisma Health-Upstate
Overall Contact

Last Name: Jessica L Britt, PhD

Phone: 864-455-8009

Email: [email protected]

Location
Facility: Status: Contact: Prisma Health Upstate Jessica Britt, PhD 864-455-8009 [email protected]
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Prisma Health-Upstate

Investigator Full Name: Jessica Britt, Ph.D.

Investigator Title: Principal Investigator

Has Expanded Access No
Arm Group

Label: Group 1 (Cases)

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

Label: Group 2 (Control)

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

Acronym PROSPER
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov