Completado

Steroid Hormones, TH1/TH2 Cytokines and Reproductive Status

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Qué se está recopilando

Recolección de datos

Quiénes están siendo reclutados

Arthritis, Rheumatoid

+ Healthy
+ Pregnancy
Cómo está diseñado el estudio

Other

Observacional
Inicio del estudio: agosto de 1994

Resumen

Patrocinador PrincipalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 1 de agosto de 1994Fecha en la que se inscribió al primer participante.

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. 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.

Título OficialSteroid Hormones, TH1/TH2 Cytokines and Reproductive Status 
Patrocinador PrincipalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 209 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
Voluntarios sanos permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Arthritis, Rheumatoid
Healthy
Pregnancy
Criterios

No current medications or hormone therapy within the last 3 months.



Centros del Estudio

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Este estudio tiene una ubicación
Suspendido
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Bethesda, United StatesVer ubicación

Completado1 Centros de Estudio