Trials / Completed
CompletedNCT05309226
Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health
Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD): A Pilot Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 43 (actual)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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 sizes, low self-reporting and no account of postpartum exposures. Therefore, this study will be conducted as a feasibility pilot study to tease out limitations that were present in previous studies. This study will help us dictate how to conduct a larger prospective cohort study to answer any knowledge gaps currently in the field of perinatal cannabis use.
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 cannabinoids, such as THC, CBD, cannabinol and their metabolic by-products cross the placenta and can enter the fetal bloodstream and distribute throughout the fetal tissues, including the brain associating to neurodevelopmental outcomes. However, these studies were limited by their sample size, based on self-reporting and did not account for postpartum exposures. Notably, the CUPiD study is a pilot study to assess the feasibility for a larger prospective study and address past limitations. We will aim to recruit 50 participants who are currently using cannabis in pregnancy and 50 participants who are not using cannabis in pregnancy within 12 months from either the Ottawa Hospital or Kingston General Hospital. The participants will be recruited any time in pregnancy and will be followed up until 4 months postpartum. Within the study period, there will be extensive data collection through surveys, diaries and medical chart reviews as well as biological sampling of the mother/birthing parent and the baby (after delivery). This work will address key issues such as recruitment rate, level of engagement, protocol compliance and appropriateness of sample size and timeframe. By piloting a pregnancy cohort from which robust data on cannabis practices can be gathered, this project will lay the foundation for downstream research in this area.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cannabis use in pregnancy or cannabis exposure in utero | Cannabis-related product use in pregnancy. Cannabis-related products will include all forms (e.g., dry flower, edibles, extracts, etc.) and formats of consumption (e.g., joint, bong, capsule, tincture, etc.). |
Timeline
- Start date
- 2022-10-10
- Primary completion
- 2025-01-07
- Completion
- 2025-02-01
- First posted
- 2022-04-04
- Last updated
- 2025-04-16
Locations
4 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT05309226. Inclusion in this directory is not an endorsement.