Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy
7 de agosto de 2013 actualizado por: University of Kentucky
GCRC: Monitoring and Outcome Measures in Asthmatics and Smokers (MOMAS) During Pregnancy
Asthma and smoking during pregnancy cause significant morbidity in both the mother and the offspring.
Asthma represents the most common respiratory disorder during pregnancy and smoking rates during pregnancy range from 15-30% in the United States.
Maternal asthma and smoking during pregnancy have been shown to increase the rate of intrauterine growth retardation and preterm delivery, as well as increase the risk of wheeze, asthma, respiratory infections, and otitis media in children.
However, controlled asthmatics during pregnancy have similar pregnancy outcomes to non-asthmatic pregnancies.
Measurement of the fractional concentration of exhaled nitric oxide (FENO) is a new, easily performed, non-invasive method that has been used to assess airway inflammation in adults and children.
The long term goal of this study is to establish baseline FENO values and to monitor airway disease in pregnant asthmatics, pregnant smokers and pregnant controls, and to correlate these levels with other inflammatory markers in the mothers and their offspring.
These values will be correlated with current methods to diagnose and monitor disease control in these patients.
The use of FENO levels in the pregnant asthmatic may prove to be a better method for monitoring disease control and titrating steroid doses in this population.
Finally, this study may identify children at higher risk of developing asthma or allergic disease.
This could serve to identify factors that may be modified to prevent or limit the development of these diseases in this population.
Descripción general del estudio
Estado
Retirado
Condiciones
Tipo de estudio
De observación
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 35 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Subjects will be recruited from clinics at the University of Kentucky and from the surrounding community.
Descripción
Inclusion Criteria:
- Patients need to be pregnant to participate in the study.
- Patients need to be aged 18 to 35 to participate in the study.
- Smokers must have smoked over 100 cigarettes in their lifetime and currently smoke 5 or more cigarettes per day.
- Asthmatics must be diagnosed with asthma and have a current prescription for an asthma medication such as albuterol or an inhaled steroid.
Exclusion Criteria:
Nonsmokers
- Cannot have smoked more than 100 cigarettes in their lifetime or currently smoke.
- Cannot have any other lung diseases such as asthma, emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
Smokers
- Cannot have any other lung diseases such as emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
Asthmatics
- Patients in the asthma group cannot have taken theophylline (Theo-24, Theolair, Uniphyl) within 6 months of this study.
- Asthmatics cannot have smoked over 100 cigarettes in their lifetime or be current smokers.
- Cannot have any other lung diseases such as emphysema (COPD), lung cancer, liver disease, cystic fibrosis or other significant respiratory diseases.
- Cannot have been treated with oral steroids or had a respiratory infection in the 4 weeks before study entry.
- Cannot have another illness that can significantly affect quality of life (such as depression or cancer).
All Subjects
- All subjects will be required to avoid antihistamines for 5 days prior to skin testing (can cause false negative results).
- All subjects will be required to avoid food, drink, exercise, and smoking 1 hour prior to exhaled nitric oxide measurement (could falsely increase or decrease levels), and will need to avoid foods that have a high nitrate content for 24 hours prior to exhaled nitric oxide measurement.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Pregnant Asthmatics
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Pregnant Smokers
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Healthy Pregnant Controls
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Exhaled nitric oxide levels
Periodo de tiempo: 9 months
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9 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Inhaled corticosteroid dose
Periodo de tiempo: 9 months
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9 months
|
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Asthma control/exacerbations
Periodo de tiempo: 9 months
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9 months
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Peripheral blood inflammatory markers
Periodo de tiempo: 9 months
|
9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: James Temprano, M.D., M.H.A., University of Kentucky
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2007
Finalización primaria (Actual)
1 de octubre de 2010
Finalización del estudio (Actual)
1 de octubre de 2010
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2007
Primero enviado que cumplió con los criterios de control de calidad
22 de enero de 2007
Publicado por primera vez (Estimar)
23 de enero de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de agosto de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2013
Última verificación
1 de agosto de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 06-0578-F2L
- 2K12DA014040-06 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .