Status:
COMPLETED
Bupropion and Specific Cardiovascular Malformations
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Pregnancy
Eligibility:
FEMALE
12-49 years
Brief Summary
The study is an extension of earlier work based on a retrospective epidemiologic study of infants born to women who were exposed to bupropion in their estimated first trimester of pregnancy using data...
Detailed Description
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develo...
Eligibility Criteria
Inclusion
- The inclusion criteria will be the same as that used previously in the retrospective epidemiologic study of infants born to women who were exposed to bupropion in their estimated first trimester of pregnancy using data from a large US health plan affiliated with i3 Drug Safety.
- All deliveries occurring between 01 January 1995 and 30 September 2004 among women ages 12 to 49 who are members of UnitedHealthcare
- Eligible for prescription benefits
- Have one or more dispensings of an antidepressant during the study period
- Continuously enrolled for at least eighteen months prior to delivery
- Women were required to have one year of continuous health plan membership before their delivery date.
- Women were also included when the associated infant remained on the insurance plan.
Exclusion
- Members who are employees of UnitedHealthcare are excluded from the Ingenix Research Database.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
7005 Patients enrolled
Trial Details
Trial ID
NCT01165255
Start Date
June 1 2010
End Date
December 1 2010
Last Update
June 7 2017
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