Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy (NCT04962477) | Clinical Trial Compass
CompletedNot Applicable
Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy
United States48 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.