Status:
COMPLETED
Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Lead Sponsor:
Canadian Network for Observational Drug Effect Studies, CNODES
Collaborating Sponsors:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Conditions:
Ventricular Tachyarrhythmia
Sudden Cardiac Death
Eligibility:
FEMALE
15-55 years
Brief Summary
The purpose of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following delivery. The...
Detailed Description
The overall objective of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following del...
Eligibility Criteria
Inclusion
- Women aged between 15 and 55 years old with live births between April 1, 1997 and December 31, 2016 (or the latest available data at each site)
Exclusion
- Women with less than 365 days of healthcare coverage prior to the start of pregnancy
- Women with a domperidone prescription in the year prior to or during pregnancy
- Women with a diagnosis of Parkinson's disease or other diseases that cause autonomic dysfunction or use of antiparkinsonian agents anytime before delivery
- Women with a diagnosis of gastroparesis in the year prior to or during pregnancy
- Women with a diagnosis of ventricular tachyarrhythmia in the year prior to or during pregnancy
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
184929 Patients enrolled
Trial Details
Trial ID
NCT04024865
Start Date
September 1 2017
End Date
July 31 2019
Last Update
September 19 2024
Active Locations (1)
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1
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2