Status:
COMPLETED
Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Kingston Health Sciences Centre
Children's Hospital of Eastern Ontario Research Institute
Conditions:
Cannabis Use
Marijuana Use
Eligibility:
All Genders
16+ years
Brief Summary
With perinatal cannabis use rising in Canada, robust data on short-term and long-term effects on newborns are urgently needed. However, past barriers to obtain robust data included limited sample size...
Detailed Description
Since Canadian legalization of cannabis in October 2018, reports of cannabis use have increased even among pregnant women/individuals. Previous work has identified that cannabis products known as cann...
Eligibility Criteria
Inclusion
- MOTHER INFANT DYADS
- Exposed and unexposed pregnant women/individuals must meet all of the following inclusion criteria at the time of enrollment to be eligible:
- Capacity to provide informed consent and to comprehend and comply with the study requirements
- Planning to deliver at TOH or KGH, or The Ottawa Birth and Wellness Centre (affiliated with TOH)
- Be ≥ 16 years of age at the time of consent
- Exposed group: pregnant women/individuals who are using any cannabis-related product in pregnancy at the time of enrollment, or have used cannabis-related products in the current pregnancy for any reason (including but not limited to recreational use, to ease nausea and vomiting, use for chronic pain management or other medical indications).
- Unexposed group: pregnant women/individuals who are not using cannabis-related products in pregnancy, and who have not used any cannabis-related product for at least 3-months prior to pregnancy.
Exclusion
- Women/Individuals who self-report non-prescription use of controlled and illegal drugs in their current pregnancy (i.e., benzodiazepines, cocaine and crack, fentanyl, heroin, ketamine, lysergic acid diethylamide, magic mushrooms, MDMA, methamphetamine, gamma hydroxybutyrate, opioids, phenylcyclohexyl piperidine, salvia) or report their use in the 3-months prior to pregnancy. (\*\*Use of alcohol or tobacco products prior to pregnancy or during pregnancy will not be an exclusion criterion\*\*)
- Women/Individuals who self-report prescription use of opioid medications including methadone, Subutex, buprenorphine, tramadol, oxycodone, hydrocodone, and hydromorphine in their current pregnancy, or report their use in the 3 months prior to pregnancy
- Surrogate or planning to give child up for adoption
- PARTNERS 'Partner' will be broadly defined as any individual identified as such by an enrolled pregnant participant (any sex or gender, any status - marital, common-law, or otherwise). Thus, eligible partners must meet all of the following inclusion criteria at the time of enrollment:
- Pregnant partner is enrolled in the CUPiD cohort study
- Have capacity to provide informed consent and to comprehend and comply with the study requirements
- Be ≥ 16 years of age at the time of consent
- There are no pre-defined exclusion criteria for partners.
Key Trial Info
Start Date :
October 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05309226
Start Date
October 10 2022
End Date
February 1 2025
Last Update
April 16 2025
Active Locations (4)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
2
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
3
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1H 8L6
4
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6