COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes

Covid19 Clinical Trial

— COVID-PRICE  

Official title:

COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04659759
• Other study ID #: 20F.1043
• Status: Active, not recruiting
• Start date: November 17, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

Description:

This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of COVID-19 in pregnancy or within 6 months post partum

• Planned delivery at Thomas Jefferson University Hospital

Exclusion Criteria:

• Declines routine COVID testing on admission

• In active labor/pain/otherwise unable to provide consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• COVID-19 exposure
COVID-19 exposure during pregnancy

Biological:
• COVID-19 vaccine
Receipt of any COVID-19 vaccine

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Nemours

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal COVID-19 serology (IgG and IgM)	IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19	6 weeks post partum
Primary	Maternal/neonatal IgG and IgM concordance	IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling	Delivery
Primary	Maternal COVID serology time/profile following vaccination	Baseline, 1m, 3m, 6m post second vaccine dose	6 months
Primary	Breastmilk Serology	Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women	6months
Secondary	Breastmilk Serology	COVID-19 IgG and IgA in breast milk	Delivery
Secondary	Breastmilk Serology	COVID-19 IgG and IgA in breastmilk	6 weeks post partum
Secondary	Cytokine	Compare maternal COVID (+) and COVID (-) cytokine panel	Delivery
Secondary	Neonatal cytokine	Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery	Delivery
Secondary	COVID disease vs vaccination immune response	Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine	6 months
Secondary	COVID vaccine in pregnant vs nonpregnant	Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine	6 months