Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Active, not recruiting

• Conditions: Pregnancy Related; Innate Inflammatory Response

• Registration Number: NCT04962477
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2022-03-02
• Primary Completion: 2023-09-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of viral entry factors	Dec 2021

Secondary Outcome Measures

Name	Time	Method
Expression of genes involved in innate immune response and host-pathogen interaction	Dec 2021

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States