Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD)

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

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Use; Cannabis Use
• Intervention / Treatment: Other: Cannabis use in pregnancy or cannabis exposure in utero

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - General Campus
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - Civic Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The primary study population will consist of pregnant individuals who are or are not using cannabis in pregnancy, and their infants. Partners will be invited to participate in a one-time survey.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Cannabis User; 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; 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.).
Pregnant Cannabis Non-User; 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; Infants born to pregnant participants who disclose cannabis use in pregnancy	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.).
Offspring of Pregnant Cannabis Non-User; Infants born to pregnant participants who report no cannabis use in pregnancy
Partners; Partners of pregnant participants enrolled in this study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Children's Hospital of Eastern Ontario Research Institute; Kingston Health Sciences Centre
• Investigators: Principal Investigator: Mark Walker, MD, MSc, MHM, Ottawa Hospital Research Institute; Principal Investigator: Daniel Corsi, PhD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; cannabis; marijuana; perinatal
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Use; Marijuana Abuse
• Other Study ID Numbers: CTO 3791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No