Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 22, 2007 | ||||
| Last Updated Date | February 20, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Exhaled nitric oxide levels [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Exhaled nitric oxide levels | ||||
| Change History | Complete list of historical versions of study NCT00425880 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monitoring and Outcome Measures in Asthmatics and Smokers During Pregnancy | ||||
| Official Title ICMJE | GCRC: Monitoring and Outcome Measures in Asthmatics and Smokers (MOMAS) During Pregnancy | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects will be recruited from clinics at the University of Kentucky and from the surrounding community. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Nonsmokers
Smokers
Asthmatics
All Subjects
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| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00425880 | ||||
| Other Study ID Numbers ICMJE | 06-0578-F2L, 2 K12 DA 14040-06 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | James Temprano, MD, MHA, University of Kentucky | ||||
| Study Sponsor ICMJE | University of Kentucky | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kentucky | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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