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

• Conditions: Covid19
• Interventions: Other: COVID-19 exposure; Biological: COVID-19 vaccine

• Registration Number: NCT04659759
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2020-11-17
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-09
• Primary Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Positive	COVID-19 exposure	Patients diagnosed with COVID-19 during pregnancy or while breastfeeding
COVID-19 vaccine	COVID-19 vaccine	Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding

Primary Outcome Measures

Name	Time	Method
Maternal COVID serology time/profile following vaccination	6 months	Baseline, 1m, 3m, 6m post second vaccine dose
Maternal/neonatal IgG and IgM concordance	Delivery	IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
Breastmilk Serology	6months	Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women
Maternal COVID-19 serology (IgG and IgM)	6 weeks post partum	IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19

Secondary Outcome Measures

Name	Time	Method
Breastmilk Serology	6 weeks post partum	COVID-19 IgG and IgA in breastmilk
Neonatal cytokine	Delivery	Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery
Cytokine	Delivery	Compare maternal COVID (+) and COVID (-) cytokine panel
COVID disease vs vaccination immune response	6 months	Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine
COVID vaccine in pregnant vs nonpregnant	6 months	Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States