Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy

7 de agosto de 2013 atualizado 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.

Visão geral do estudo

Status

Retirado

Condições

Tipo de estudo

Observacional

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Estados Unidos
- Kentucky
  - Lexington, Kentucky, Estados Unidos, 40536
    - University of Kentucky

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 35 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

Subjects will be recruited from clinics at the University of Kentucky and from the surrounding community.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Pregnant Asthmatics
Pregnant Smokers
Healthy Pregnant Controls

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Prazo
Exhaled nitric oxide levels Prazo: 9 months	9 months

Medidas de resultados secundários

Medida de resultado	Prazo
Inhaled corticosteroid dose Prazo: 9 months	9 months
Asthma control/exacerbations Prazo: 9 months	9 months
Peripheral blood inflammatory markers Prazo: 9 months	9 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Kentucky

Investigadores

Investigador principal: James Temprano, M.D., M.H.A., University of Kentucky

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2007

Conclusão Primária (Real)

1 de outubro de 2010

Conclusão do estudo (Real)

1 de outubro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ