Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001376
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Steroid Hormones TH1TH2 Cytokines and Reproductive Status
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Steroid Hormones TH1TH2 Cytokines and Reproductive Status
Status:
COMPLETED
Status Verified Date:
1999-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-AR-0196 | None | None | None |