Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

NCT04962477 | Completed

• 1 other identifier: 202107016
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Innate Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• Expression of viral entry factors

  Dec 2021

Secondary Outcomes (1)

• Expression of genes involved in innate immune response and host-pathogen interaction

  Dec 2021

Study Arms (2)

Pregnant

Other: Nasal brush sampling

Non-pregnant

Other: Nasal brush sampling

Interventions

Nasal brush sampling OTHER

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; Pregnant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females are eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal brush samples

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arvind Palanisamy, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 15, 2021
• Study Start: March 2, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)