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PROSPER: COVID-19 on Placental Gene Expression and Pathology

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04585945
Collaborator
(none)
100
Enrollment
1
Location
28.9
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Positive for SARS-CoV-2 infection

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Pregnancy Outcomes During the Pandemic: Using Placental Pathology and Gene Expression to Understand Fetal Risk
Actual Study Start Date :
Aug 4, 2020
Actual Primary Completion Date :
Apr 21, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.]

    Umbilical cord blood will be analyzed using an inflammatory biomarker panel (TNF, IL6, CRP, IL4, IL13)

  2. 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.]

    A perinatal pathologist will review placental pathology findings to determine the occurrence of inflammatory processes, vasculopathy, and villous maturity, as reflected in histology.

  3. 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.]

    Gene expression analysis will be conducted to identify altered gene expression patterns related to placental development (inflammation, vascularity, and metabolism).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prisma Health Upstate Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT04585945
Other Study ID Numbers:
  • Pro00101090
First Posted:
Oct 14, 2020
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 2, 2022