Healthy Clinical Trial
Official title:
Steroid Hormones, TH1/TH2 Cytokines and Reproductive Status
This study is designed to evaluate blood Th1 and Th2 immunoregulatory cytokine production
and hormonal levels associated with the third trimester of pregnancy and the postpartum
state. Cytokine and hormone levels will be assessed in blood specimens obtained from healthy
pregnant and postpartum females and compared to levels from premenopausal non-pregnant and
non-postpartum females. Blood samples obtained at 30-36 weeks of gestation and 2-6 weeks
postpartum will be the primary study points. Samples will also be obtained from pregnant,
postpartum, and non-pregnant, non-postpartum, premenopausal female patients with rheumatoid
arthritis. Additional data will be generated from samples from normal males, which will be
compared with data from females.
We expect to find that pregnancy is associated with enhanced Th2 cytokine expression and
that the postpartum state is associated with enhanced Th1 cytokine expression. We expect to
see differences in cytokine expression between males and females as well. We seek to gather
data supporting the view that distinct hormonal environments regulate these contrasting
immunological states.
Status | Completed |
Enrollment | 209 |
Est. completion date | June 2000 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility | No current medications or hormone therapy within the last 3 months. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Bell SC, Billington WD. Major anti-paternal alloantibody induced by murine pregnancy is non-complement-fixing IgG1. Nature. 1980 Nov 27;288(5789):387-8. — View Citation
Cadet P, Rady PL, Tyring SK, Yandell RB, Hughes TK. Interleukin-10 messenger ribonucleic acid in human placenta: implications of a role for interleukin-10 in fetal allograft protection. Am J Obstet Gynecol. 1995 Jul;173(1):25-9. — View Citation
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