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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD): A Pilot Prospective Cohort Study

Conditions
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Cannabis Use, Marijuana Use

Intervention / Treatment
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* Other: Cannabis use in pregnancy or cannabis exposure in utero


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Cannabis User<br>Pregnant individuals who disclose cannabis use in pregnancy We will examine patterns of cannabis use including the type of cannabis used, amount and frequency of cannabis use during the perinatal and postpartum periods. If participant decides to stop using cannabis in pregnancy, they will not be excluded from the study. | Other: Cannabis use in pregnancy or cannabis exposure in utero<br>* 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.).<br>|
| Pregnant Cannabis Non-User<br>Pregnant individuals who report not using cannabis in pregnancy and who have not used cannabis products for at least 3-months prior to pregnancy. | |
| Offspring of Pregnant Cannabis User<br>Infants born to pregnant participants who disclose cannabis use in pregnancy | Other: Cannabis use in pregnancy or cannabis exposure in utero<br>* 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.).<br>|
| Offspring of Pregnant Cannabis Non-User<br>Infants born to pregnant participants who report no cannabis use in pregnancy | |
| Partners<br>Partners of pregnant participants enrolled in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of eligibility criteria | Measured by the reasons for exclusion of screened subjects | Within first year | 
| Recruitment rate | Measured by the proportion of eligible cases and controls recruited into the cohort | Within first year | 
| Level of engagement | Measured by the proportion of recruited subjects contributing data and biospecimens at each time point | Within first year | 
| Protocol compliance | Measured by attrition rate (loss to follow-up or withdrawal of consent) of enrolled subjects | Within first year | 
| Appropriateness of sample size and time frame | Measured by the timeframe required to recruit target sample size | Within first year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal and neonatal morbidity (preterm) | Rates of: Preterm Birth (<37 weeks' gestation; 34 to 36 weeks' gestation (late preterm);32 to 33 weeks' gestation; 28 to 31 weeks' gestation; <28 weeks' gestation (very preterm birth)) | Throughout pregnancy until 6-12 weeks postpartum | 
| Fetal and neonatal morbidity (sga) | Rates of: small for gestational age (<10th and <3rd percentiles) | Throughout pregnancy until 6-12 weeks postpartum | 
| Neonatal morbidity (NICU) | Rates of: neonatal ICU admission | Throughout pregnancy until 6-12 weeks postpartum | 
| Neonatal morbidity (apgar) | Rates of: low Apgar (<4 at 5 min) | Throughout pregnancy until 6-12 weeks postpartum | 
| Fetal and neonatal morbidity | Rates of: stillbirth, spontaneous abortion, elective termination | Throughout pregnancy until 6-12 weeks postpartum | 
| Maternal morbidity | Rates of: gestational diabetes, pre-eclampsia, placental abruption | Throughout pregnancy until 6-12 weeks postpartum | 
| Mode of delivery | Rates of cesarean sections and vaginal deliveries | Through study completion, about every 9-months | 
| Child growth (weight) | weight | 6-12 weeks postpartum | 
| Child growth (head circumference) | head circumference | 6-12 weeks postpartum | 
| Child growth (height) | length | 6-12 weeks postpartum | 
| Child Major Illnesses/conditions | Proportion of children receiving diagnoses of major illness/conditions | Delivery to 6-12 weeks postpartum | 
| Hospitalizations | Proportion of mothers and infants re-admitted to hospital | Delivery to 6-12 weeks postpartum | 
| Emergency care visits | Proportion of mothers and infants with emergency care visits | Delivery to 6-12 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perinatal, cannabis, pregnancy, marijuana