Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
NCT ID: NCT01548105
Last Updated: 2014-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2012-03-31
2013-03-31
Brief Summary
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Detailed Description
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Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Prolapse and Smoker
Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and have been smoking more than one pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
Blood draw for the study participants
These will include:
* Procollagen 1-N propeptide levels (PINP)
* Matrix metalloproteinase (MMP9)
* Plasma Vitamin C levels
Prolapse and non smoker
Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
Blood draw for the study participants
These will include:
* Procollagen 1-N propeptide levels (PINP)
* Matrix metalloproteinase (MMP9)
* Plasma Vitamin C levels
No prolapse and smoker
Patients in this arm, have been determined not to have prolapse and smokes more than 1 pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
Blood draw for the study participants
These will include:
* Procollagen 1-N propeptide levels (PINP)
* Matrix metalloproteinase (MMP9)
* Plasma Vitamin C levels
No prolapse and non smoker
Patients in this arm have been determined not to have prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
Blood draw for the study participants
These will include:
* Procollagen 1-N propeptide levels (PINP)
* Matrix metalloproteinase (MMP9)
* Plasma Vitamin C levels
Interventions
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Blood draw for the study participants
These will include:
* Procollagen 1-N propeptide levels (PINP)
* Matrix metalloproteinase (MMP9)
* Plasma Vitamin C levels
Eligibility Criteria
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Inclusion Criteria
* Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions
* For smoker group- smoke more than one pack per day
* For non smoker group- non smoker for more than 7 years
No Prolapse group:
* Absence of prolapse and negative answer to the screening questions
Exclusion Criteria
* Using vaginal estrogen (cream, ring, tablet)
* Chronic steroid use
* Past medical history of connective tissue disease
* Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure
18 Years
FEMALE
Yes
Sponsors
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TriHealth Inc.
OTHER
Responsible Party
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Principal Investigators
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Maria Victoria C Estanol, MD
Role: PRINCIPAL_INVESTIGATOR
Good Samaritan Hospital
Locations
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Good Samaritan Hospital
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Smoking and prolapse
Identifier Type: -
Identifier Source: org_study_id
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