Status:
COMPLETED
Assessment of Alterations in Immune Function During Pregnancy and Post Parturition
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pregnancy Immune Function
Eligibility:
FEMALE
18-45 years
Brief Summary
Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppres...
Detailed Description
Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppres...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All pregnant study subjects must:
- Be between the ages of 18-45 years old.
- Have a positive pregnancy test (urine).
- Be of an estimated gestational age of between 10 and 20 weeks either by ultrasound or LMP.
- Have an identified primary care provider for the pregnancy.
- Be willing to sign the collaborative study consent form from CHI.
- Be willing to have samples collected and stored for future research and immunological studies
- Be willing to sign the collaborative study consent form for normal volunteers from CHI
- Up to twenty pregnant subjects who agree to receive the seasonal influenza vaccine must:
- Have no history of allergic reaction to the vaccine or its contents
- Not have received the vaccine from other providers this flu season
- Agree to have an additional 20cc of blood drawn at both Day +1 and Day +7 post-vaccine for immune analysis.
- EXCLUSION CRITIERIA:
- A subject will be excluded if she:
- Has an identified underlying chronic medical condition that may adversely affect the immune system (e.g., autoimmune, HIV, or hematologic) or the need for immunomodulating medications (e.g., oral steroids) within 30 days prior to conception for a suspected immune disorder. Oral steroid use for any other reason must have been discontinued for at least 30 days prior to participation.
- Is found to have a Hemoglobin reading of less than 8g/dL.
- Has any other medical condition which, in the opinion of the Principal Investigator, poses an unacceptable risk to the subject s participation in the study.
Exclusion
Key Trial Info
Start Date :
September 30 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01200979
Start Date
September 30 2011
End Date
October 11 2019
Last Update
October 18 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892