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Completed

NCT Number: NCT05309226

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre, Kingston, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabis use in pregnancy or cannabis exposure in utero

Other

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.).

Primary outcomes

  1. Appropriateness of eligibility criteria

    Time frame: Within first year

    Measured by the reasons for exclusion of screened subjects

  2. Recruitment rate

    Time frame: Within first year

    Measured by the proportion of eligible cases and controls recruited into the cohort

  3. Level of engagement

    Time frame: Within first year

    Measured by the proportion of recruited subjects contributing data and biospecimens at each time point

  4. Protocol compliance

    Time frame: Within first year

    Measured by attrition rate (loss to follow-up or withdrawal of consent) of enrolled subjects

  5. Appropriateness of sample size and time frame

    Time frame: Within first year

    Measured by the timeframe required to recruit target sample size

Secondary outcomes

  1. Fetal and neonatal morbidity (preterm)

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    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))

  2. Fetal and neonatal morbidity (sga)

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    Rates of: small for gestational age (<10th and <3rd percentiles)

  3. Neonatal morbidity (NICU)

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    Rates of: neonatal ICU admission

  4. Neonatal morbidity (apgar)

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    Rates of: low Apgar (<4 at 5 min)

  5. Fetal and neonatal morbidity

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    Rates of: stillbirth, spontaneous abortion, elective termination

  6. Maternal morbidity

    Time frame: Throughout pregnancy until 6-12 weeks postpartum

    Rates of: gestational diabetes, pre-eclampsia, placental abruption

  7. Mode of delivery

    Time frame: Through study completion, about every 9-months

    Rates of cesarean sections and vaginal deliveries

  8. Child growth (weight)

    Time frame: 6-12 weeks postpartum

    weight

  9. Child growth (head circumference)

    Time frame: 6-12 weeks postpartum

    head circumference

  10. Child growth (height)

    Time frame: 6-12 weeks postpartum

    length

  11. Child Major Illnesses/conditions

    Time frame: Delivery to 6-12 weeks postpartum

    Proportion of children receiving diagnoses of major illness/conditions

  12. Hospitalizations

    Time frame: Delivery to 6-12 weeks postpartum

    Proportion of mothers and infants re-admitted to hospital

  13. Emergency care visits

    Time frame: Delivery to 6-12 weeks postpartum

    Proportion of mothers and infants with emergency care visits

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Children's Hospital of Eastern Ontario Research Institute
  • Kingston Health Sciences Centre

Registry information

Official study title

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

Acronym: CUPiD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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