Utilization and Adverse Outcomes of Ondansetron and Fluconazole Therapy during Pregnancy

Project number: 
17-094
Approval date: 
Friday, September 22, 2017
Principal Investigator: 
Dormuth,Colin
Institution: 
University of British Columbia (UBC)
Funding Agency: 
Canadian Institutes of Health Research(CIHR)
Datasets requested: 
Not available
Research objective: 

RESEARCH QUESTIONS

The overall objective is to determine the utilization of ondansetron and fluconazole during pregnancy in Canada, and whether the use of these drugs adversely affects pregnancy outcomes. The BC CNODES site will apply these objectives to BC data. Our specific objectives are:

1) To determine utilization patterns of ondansetron and other antiemetics (AEs - anti-nausea & vomiting drugs) during pregnancy in BC
2) To determine utilization patterns of low-dose fluconazole and other antifungals (AFs) during pregnancy in BC
3) To determine whether the use of ondansetron (alone or in combination with other antiemetic drugs), compared to alternative AEs, is associated with an increased risk of fetal anomaly, and other adverse pregnancy outcomes
4) To determine whether the use of fluconazole, including low-dose fluconazole, compared to alternative antifungals, is associated with an increased risk of fetal anomaly, and other adverse pregnancy outcomes.

HYPOTHESES

1) Based on prior research in other countries, we expect over 20% of women to be exposed to ondansetron during pregnancy. We expect an even greater number will be exposed to other AEs.
2) Based on prior research in other countries, we expect a very small percentage (0.5%) of women to be exposed to fluconazole during pregnancy and a similarly small percentage to other AFs.
3) We do not expect use of ondansetron during pregnancy to increase the risk of spontaneous abortion, stillbirth, or major birth defects; however, we do anticipate an increased rate of less serious adverse pregnancy outcomes in ondansetron users.
4) We expect women exposed to high doses of fluconazole during pregnancy to have a higher rate of adverse pregnancy outcomes.


Page last revised: May 13, 2019