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Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy

2013년 8월 7일 업데이트: 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.

연구 개요

상태

빼는

정황

연구 유형

관찰

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Kentucky
  - Lexington, Kentucky, 미국, 40536
    - University Of Kentucky

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Pregnant Asthmatics
Pregnant Smokers
Healthy Pregnant Controls

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	기간
Exhaled nitric oxide levels 기간: 9 months	9 months

2차 결과 측정

결과 측정	기간
Inhaled corticosteroid dose 기간: 9 months	9 months
Asthma control/exacerbations 기간: 9 months	9 months
Peripheral blood inflammatory markers 기간: 9 months	9 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Kentucky

수사관

수석 연구원: James Temprano, M.D., M.H.A., University Of Kentucky

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 1월 1일

기본 완료 (실제)

2010년 10월 1일

연구 완료 (실제)

2010년 10월 1일

연구 등록 날짜

최초 제출

2007년 1월 22일

QC 기준을 충족하는 최초 제출