- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00818896
Maternal Hypothyroidism in Pregnancy
A Model Statewide Trial to Detect and Treat Maternal Hypothyroidism in Pregnancy
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a model community-based trial in Rhode Island (RI), aimed at avoiding or minimizing morbidity from overt maternal hypothyroidism by systematic detection and treatment, beginning at the 1st prenatal visit. This model can be superimposed on existing prenatal screening programs and is intended ultimately to replace "case-finding", which has recently been shown ineffective. Three aspects of maternal and child health are compromised when a pregnant woman is thyroid deficient: 1) the woman's own health and well-being; 2) her baby's brain development; and 3) overall health of the pregnancy (e.g., fetal death, prematurity, preeclampsia). Thyroid stimulating hormone (TSH) measurement, a well accepted indicator of thyroid dysfunction, will serve as the primary test for both diagnosis and monitoring. A TSH value >10 mU/L indicates overt hypothyroidism. Among the state's 14,000 annual pregnancies, 42 women (0.3%) will be overtly hypothyroid early in gestation (32 undiagnosed, and 10 under-treated). TSH values between 4.5 mU/L (98th centile) and 9.9 mU/L indicate subclinical hypothyroidism. The 240 women in this category will also receive treatment, and information will be gathered about disease progression to inform future practice. Approximately half of all RI's pregnancies are cared for by practices in Greater Providence, and TSH testing will initially be introduced, there. The research component is also within that area. Testing will subsequently be extended to the entire state. The program is centrally managed by three units at Women and Infants Hospital, in consultation with RI's Birth Defects Program Director. Program goals are to: provide TSH testing to at least 70% of pregnant women in Greater Providence; provide TSH testing to at least 50% of pregnant women elsewhere in RI; test 70% of screened women by 12 weeks' gestation, and 90% by 18 weeks' gestation; begin treatment in Greater Providence by 13 weeks' in 70%, and by 19 weeks' in 90%; document successful treatment during pregnancy in 90% (TSH >0.1 mU/L and <2.0 mU/L; retain 95% treated women to end of pregnancy, and 90% for up to 1 year postpartum; obtain pregnancy complications and birth outcomes for the entire cohort (Vital Records).
Data will be collected on participation by practices and women, % of women with undiagnosed thyroid deficiency, compliance with follow-up and treatment during pregnancy and for up to one year afterwards, outcomes of their pregnancies, % of hypothyroid women with postpartum thyroid dysfunction, % of women with subclinical hypothyroidism who remain hypothyroid one year postpartum, physician attitudes, and program costs.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- Women & Infants Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- TSH value >98th centile in early pregnancy
Exclusion Criteria:
- Women with known hypothyroidism
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Percent of women who develop permanent hypothyroidism.
Periodo de tiempo: Up to two years
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Up to two years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Percent of women with post-partum thyroid dysfunction.
Periodo de tiempo: Up to two years
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Up to two years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James E. Haddow, M.D., Women & Infants Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB #08-0005
- R18DP001148 (Subvención/contrato del NIH de EE. UU.)
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