TerminatedNot Applicable

NK Cell Mediated Influenza Immunity During Pregnancy

United States94 participantsStarted 2012-08-14

Plain-language summary

Pregnant women have increased morbidity and mortality due to infection with influenza. Changes in T cell function have been proposed as possible mechanisms for this finding. We believe that pregnancy induced changes in NK cell phenotype and function also impact influenza immunity. This study will compare the immune response of pregnant women and controls to TIV influenza vaccination as a surrogate for infection. In addition pregnant women with flu like illness will be enrolled to evaluate changes in immune response following influenza infection as compared to vaccination.

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: * Pregnant women (18-42 years of age) * Pregnant women planning to receive the TIV seasonal influenza vaccine or Pregnant women presenting with influenza like illness Exclusion Criteria: * Oral immunosuppressive agents (inhaled steroids OK) * Serious chronic illness including autoimmune disease or chronic viral infections (eg, systemic lupus erythematosis,HIV, hepatitis B or C) * Malignancy or blood dyscrasia * Type I or II diabetes or morbid obesity (pre-pregnancy BMI\>40)(gestational diabetes ok) * Presence of fetal cardiac abnormalities * Receipt of blood or blood products within the last year * Prior receipt of current seasonal influenza vaccine for influenza vaccine arm * History of egg allergy for influenza vaccine arm

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.

What they're measuring

NK cell function

Timeframe: 2 years

Trial details

NCT IDNCT03196245

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-04-01

View on ClinicalTrials.gov More Pregnancy Related trials