Pregnancy RelatedNCT04962477
Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy
An observational study of Pregnancy Related and Innate Inflammatory Response, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Innate Inflammatory Response
- What is being tested?
- Nasal brush sampling
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
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
- Being tested
- Nasal brush sampling
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal brush samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant | Not described Receives: Other: Nasal brush sampling | |
| Non-pregnant | Not described Receives: Other: Nasal brush sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of viral entry factors
Measured: Dec 2021
Secondary outcomes (1)
Expression of genes involved in innate immune response and host-pathogen interaction
Measured: Dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start2 Mar 2022
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvind Palanisamy, Washington University School of Medicine
- Investigators
- Arvind Palanisamy, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962477
- Sponsor's protocol ID
- 202107016
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy
- ClinicalTrials.gov ID
- NCT04962477
- Acronym / sponsor ID
- 202107016
- Conditions
- Pregnancy Related, Innate Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Other: Nasal brush sampling |
| Non-pregnant | – | Other: Nasal brush sampling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal brush samplingNasal 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. | Other | Non-pregnant, Pregnant |
Primary outcome
Expression of viral entry factors
Time frame: Dec 2021
1 secondary outcome
Expression of genes involved in innate immune response and host-pathogen interaction
Time frame: Dec 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvind Palanisamy, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Innate Inflammatory Response, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of viral entry factors (time frame: Dec 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.