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Domperidone and Risk of Serious Cardiac Events in Postpartum Women

NCT04024865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184929

Last updated 2024-09-19

No results posted yet for this study

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 hypothesis is that the use of domperidone will be associated with an increased risk of serious cardiac events among postpartum women.

The investigators will carry out separate population-based cohort studies using health care databases in five Canadian provinces. Women with live births will be eligible to enter the cohort. We will identify all women who start domperidone during the six months following delivery and match them to similar women who do not start domperidone, with all included women followed until the occurrence of an adverse cardiac event or for up to six months after delivery. The results from the separate sites will be combined to provide an overall assessment of the risk of serious cardiac events in users of domperidone.

Conditions

Interventions

DRUG

Domperidone

Women who received a prescription for domperidone (ATC A03FA03) during the six months following delivery.

DRUG

No domperidone

Women with no prescription for domperidone during the six months following delivery.

Sponsors & Collaborators

  • Drug Safety and Effectiveness Network, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Network for Observational Drug Effect Studies, CNODES

    lead OTHER

Principal Investigators

  • Kristian B Filion, PhD · McGill University

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024865 on ClinicalTrials.gov