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Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00327639
Recruitment Status : Unknown
Verified July 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : May 18, 2006
Last Update Posted : May 18, 2006
Sponsor:
Information provided by:
University Health Network, Toronto

Tracking Information
First Submitted Date May 17, 2006
First Posted Date May 18, 2006
Last Update Posted Date May 18, 2006
Study Start Date July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
Official Title Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
Brief Summary Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Thalassemia
  • Fertility
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: May 17, 2006)
50
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
  • Subject has attempted conception

Exclusion Criteria:

  • Subject has any other form of blood disease
  • Subject has not attempted conception
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00327639
Other Study ID Numbers 00000
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor University Health Network, Toronto
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Nancy F Olivieri, MD University Health Network, Toronto General Hospital
PRS Account University Health Network, Toronto
Verification Date July 2005