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Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962477
Enrollment
48
Registered
2021-07-15
Start date
2022-03-02
Completion date
2023-09-27
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Innate Inflammatory Response, Pregnancy Related

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.

Interventions

OTHERNasal 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Expression of viral entry factorsDec 2021

Secondary

MeasureTime frame
Expression of genes involved in innate immune response and host-pathogen interactionDec 2021

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026