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Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health

Recruiting
16 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

MOTHER INFANT DYADS

Inclusion Criteria:

        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 Criteria:
          -  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.

Study details

Cannabis Use, Marijuana Use

NCT05309226

Ottawa Hospital Research Institute

26 January 2024

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