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Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy

2013年8月7日更新者：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.

研究概览

地位

撤销

条件

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Kentucky
  - Lexington、Kentucky、美国、40536
    - University of Kentucky

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Pregnant Asthmatics
Pregnant Smokers
Healthy Pregnant Controls

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Exhaled nitric oxide levels 大体时间：9 months	9 months

次要结果测量

结果测量	大体时间
Inhaled corticosteroid dose 大体时间：9 months	9 months
Asthma control/exacerbations 大体时间：9 months	9 months
Peripheral blood inflammatory markers 大体时间：9 months	9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Kentucky

调查人员

首席研究员：James Temprano, M.D., M.H.A.、University of Kentucky

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年1月1日

初级完成 (实际的)

2010年10月1日

研究完成 (实际的)

2010年10月1日

研究注册日期

首次提交

2007年1月22日

首先提交符合 QC 标准的