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

• ClinicalTrials.gov Identifier: NCT00327639
• Recruitment Status: Unknown
• First Posted: May 18, 2006
• Last Update Posted: May 18, 2006
• Sponsor: University Health Network, Toronto
• 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

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

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