Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Innate Inflammatory Response
• Intervention / Treatment: Other: Nasal brush sampling

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant cohort: pregnant women in their third trimester admitted to the hospital for any elective procedure (cesarean delivery, labor induction etc.,)

Non-pregnant cohort: age-matched female volunteers

Description

Inclusion Criteria:

• Healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation)
• Healthy non-pregnant adult female volunteers between the ages of 18 - 45 years.
• Between 18-45 years old
• Able to provide consent

Exclusion Criteria:

• Patients in labor
• Critically ill patients needing intubation and mechanical ventilation
• Patients with fever or influenza-like illness
• H/o epistaxis or rhinosinusitis
• Nasal polyposis and deviated nasal septum
• Preeclampsia and chronic hypertension
• Use of anti-hypertensives
• Ongoing seasonal allergy
• H/o asthma
• Recent recovery from SARS-CoV-2 or influenza A infection (≤ 4 weeks)
• Recent receipt of either COVID-19 or influenza A vaccine (≤ 4 weeks)
• Use of immunosuppressive medications
• Use of inhaled corticosteroids
• Use of hormonal contraceptives in non-pregnant population
• Allergy to local anesthetic

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant	Other: Nasal brush sampling; Nasal brush samples will be collected from the inferior turbinate using standardized techniques after local anesthetic application. After clearing the mucus from the nasal cavity by asking the patient to blow their nostrils twice followed by local anesthetic spray application, nasal brush samples will be collected from the inferior turbinate of each nostril with dedicated soft cytology brushes and pooled together for molecular biological experiments. Simultaneously, 10 mL of peripheral blood will be collected for immunophenotyping.
Non-pregnant	Other: Nasal brush sampling; Nasal brush samples will be collected from the inferior turbinate using standardized techniques after local anesthetic application. After clearing the mucus from the nasal cavity by asking the patient to blow their nostrils twice followed by local anesthetic spray application, nasal brush samples will be collected from the inferior turbinate of each nostril with dedicated soft cytology brushes and pooled together for molecular biological experiments. Simultaneously, 10 mL of peripheral blood will be collected for immunophenotyping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expression of viral entry factors	Dec 2021

Secondary Outcome Measures

Outcome Measure	Time Frame
Expression of genes involved in innate immune response and host-pathogen interaction	Dec 2021

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Arvind Palanisamy, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: 202107016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No