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

NCT04659759 | Completed

• 1 other identifier: 20F.1043
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• 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

• Maternal/neonatal IgG and IgM concordance

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

  Delivery

• Maternal COVID serology time/profile following vaccination

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

  6 months

• Breastmilk Serology

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

  6months

Secondary Outcomes (6)

• Breastmilk Serology

  Delivery

• Breastmilk Serology

  6 weeks post partum

• Cytokine

  Delivery

• Neonatal cytokine

  Delivery

• COVID disease vs vaccination immune response

  6 months

Study Arms (4)

COVID-19 Positive

Patients diagnosed with COVID-19 during pregnancy or while breastfeeding

Other: COVID-19 exposure

COVID-19 vaccine

Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding

Biological: COVID-19 vaccine

Controls

Reproductive age women exposed to COVID-19 vaccine

Pregnant Control

Pregnant women who delivered at TJUH, COVID negative

Interventions

COVID-19 exposure OTHER

COVID-19 exposure during pregnancy

COVID-19 Positive

COVID-19 vaccine BIOLOGICAL

Receipt of any COVID-19 vaccine

COVID-19 vaccine

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum

You may qualify if:

• Diagnosis of COVID-19 in pregnancy or within 6 months post partum
• Planned delivery at Thomas Jefferson University Hospital

You may not qualify if:

• Declines routine COVID testing on admission
• In active labor/pain/otherwise unable to provide consent

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Nemours: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Maternal serum/plasma * SARS-CoV-2 serology * Cytokine/chemokine panel * Cord blood serum/plasm * SARS-CoV-2 serology * Cytokine/chemokine panel * DNA methylation, miRNA/mRNA exression * Breastmilk o SARS-CoV-2 serology

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 9, 2020
• Study Start: November 17, 2020
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)