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

Prisma Health-Upstate

Status: Completed

Conditions: COVID-19; SARS-CoV-2 Infection

Treatments: Diagnostic Test: Positive for SARS-CoV-2 infection

Study type: Observational

Funder types: Other

Identifiers

NCT04585945

Pro00101090

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

68 participants in 2 patient groups

Group 1 (Cases)

Description:

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

Treatment:

Diagnostic Test: Positive for SARS-CoV-2 infection

Group 2 (Control)

Description:

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