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Completed

NCT Number: NCT04659759

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 exposure

Other

COVID-19 exposure during pregnancy

COVID-19 vaccine

Biological

Receipt of any COVID-19 vaccine

Primary outcomes

  1. Maternal COVID-19 serology (IgG and IgM)

    Time frame: 6 weeks post partum

    IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19

  2. Maternal/neonatal IgG and IgM concordance

    Time frame: Delivery

    IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling

  3. Maternal COVID serology time/profile following vaccination

    Time frame: 6 months

    Baseline, 1m, 3m, 6m post second vaccine dose

  4. Breastmilk Serology

    Time frame: 6months

    Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women

Secondary outcomes

  1. Breastmilk Serology

    Time frame: Delivery

    COVID-19 IgG and IgA in breast milk

  2. Breastmilk Serology

    Time frame: 6 weeks post partum

    COVID-19 IgG and IgA in breastmilk

  3. Cytokine

    Time frame: Delivery

    Compare maternal COVID (+) and COVID (-) cytokine panel

  4. Neonatal cytokine

    Time frame: Delivery

    Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery

  5. COVID disease vs vaccination immune response

    Time frame: 6 months

    Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine

  6. COVID vaccine in pregnant vs nonpregnant

    Time frame: 6 months

    Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Nemours

Registry information

Official study title

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

Acronym: COVID-PRICE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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