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NCT00001376 · ClinicalTrials.gov registry record
Steroid Hormones, TH1/TH2 Cytokines and Reproductive Status
A clinical trial, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- 209
- Enrollment target
NCT00001376: Completed study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT00001376 is a clinical trial that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 209 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001376 has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- 209 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 1994-08 |
| Est. Completion | 2000-06 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00001376 record still lists
NCT00001376 is an observational study that tracks outcomes without assigning an intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00001376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001376 about?
NCT00001376 is a clinical study titled "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 femal...
What is the current status of trial NCT00001376?
This trial is currently completed. The enrollment target is 209 participants. The study started on 1994-08. Estimated completion is 2000-06.
Who is sponsoring clinical trial NCT00001376?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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