Cannabis UseCUPiDNCT05309226
Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health
An observational study of Cannabis Use and Marijuana Use, run by Ottawa Hospital Research Institute at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Marijuana Use
- What is being tested?
- Cannabis use in pregnancy or cannabis exposure in utero
- Type of treatment
- Pill or oral medicine
- How many people
- 43 participants
- Where
- 4 sitesCanada
- Study dates
- 10 Oct 2022to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1H 8L6
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
About this study
Official title: 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.
Read the 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
- Cannabis Use, Marijuana Use
- Being tested
- Cannabis use in pregnancy or cannabis exposure in utero
- Keywords
- perinatal, cannabis, pregnancy, marijuana
- Medical subject headings
- Marijuana Use, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis use in pregnancy or cannabis exposure in uteroOther
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cannabis use in pregnancy or cannabis exposure in utero | |
| 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 Receives: Other: Cannabis use in pregnancy or cannabis exposure in utero | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of eligibility criteria
Measured by the reasons for exclusion of screened subjects
Measured: Within first year
Recruitment rate
Measured by the proportion of eligible cases and controls recruited into the cohort
Measured: Within first year
Level of engagement
Measured by the proportion of recruited subjects contributing data and biospecimens at each time point
Measured: Within first year
Protocol compliance
Measured by attrition rate (loss to follow-up or withdrawal of consent) of enrolled subjects
Measured: Within first year
Appropriateness of sample size and time frame
Measured by the timeframe required to recruit target sample size
Measured: Within first year
Secondary outcomes (13)
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))
Measured: Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity (sga)
Rates of: small for gestational age (<10th and <3rd percentiles)
Measured: Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (NICU)
Rates of: neonatal ICU admission
Measured: Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (apgar)
Rates of: low Apgar (<4 at 5 min)
Measured: Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity
Rates of: stillbirth, spontaneous abortion, elective termination
Measured: Throughout pregnancy until 6-12 weeks postpartum
Maternal morbidity
Rates of: gestational diabetes, pre-eclampsia, placental abruption
Measured: Throughout pregnancy until 6-12 weeks postpartum
Mode of delivery
Rates of cesarean sections and vaginal deliveries
Measured: Through study completion, about every 9-months
Child growth (weight)
weight
Measured: 6-12 weeks postpartum
Child growth (head circumference)
head circumference
Measured: 6-12 weeks postpartum
Child growth (height)
length
Measured: 6-12 weeks postpartum
Child Major Illnesses/conditions
Proportion of children receiving diagnoses of major illness/conditions
Measured: Delivery to 6-12 weeks postpartum
Hospitalizations
Proportion of mothers and infants re-admitted to hospital
Measured: Delivery to 6-12 weeks postpartum
Emergency care visits
Proportion of mothers and infants with emergency care visits
Measured: Delivery to 6-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start10 Oct 2022
- Primary completion7 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Children's Hospital of Eastern Ontario Research Institute
- Responsible party
- Sponsor
- Investigators
- Mark Walker, MD, MSc, MHM, Principal investigator, Ottawa Hospital Research InstituteDaniel Corsi, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309226
- Sponsor's protocol ID
- CTO 3791
- Acronym
- CUPiD
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramlawi S, Murphy MSQ, Dingwall-Harvey ALJ, Rennicks White R, Gaudet LM, McGee A, DeGrace A, Cantin C, El-Chaar D, Walker MC, Corsi DJ. Cannabis Use in Pregnancy and Downstream effects on maternal and infant health (CUPiD): a protocol for a birth cohort pilot study. BMJ Open. 2022 Dec 22;12(12):e066196. doi: 10.1136/bmjopen-2022-066196.
PubMed 36549747
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD): A Pilot Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05309226
- Acronym / sponsor ID
- CUPiD / CTO 3791
- Conditions
- Cannabis Use, Marijuana Use
- Keywords
- perinatal, cannabis, pregnancy, marijuana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Children's Hospital of Eastern Ontario Research Institute
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pregnant Cannabis User | – | Other: Cannabis use in pregnancy or cannabis exposure in uteroPregnant 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. |
| 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 | – | Other: Cannabis use in pregnancy or cannabis exposure in uteroInfants born to pregnant participants who disclose cannabis use in pregnancy |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis use in pregnancy or cannabis exposure in uteroCannabis-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.). | Other | Offspring of Pregnant Cannabis User, Pregnant Cannabis User |
Primary outcome
Appropriateness of eligibility criteria
Time frame: Within first year
Measured by the reasons for exclusion of screened subjects
Recruitment rate
Time frame: Within first year
Measured by the proportion of eligible cases and controls recruited into the cohort
Level of engagement
Time frame: Within first year
Measured by the proportion of recruited subjects contributing data and biospecimens at each time point
Protocol compliance
Time frame: Within first year
Measured by attrition rate (loss to follow-up or withdrawal of consent) of enrolled subjects
Appropriateness of sample size and time frame
Time frame: Within first year
Measured by the timeframe required to recruit target sample size
13 secondary outcomes
Fetal and neonatal morbidity (preterm)
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity (sga)
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (NICU)
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (apgar)
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Maternal morbidity
Time frame: Throughout pregnancy until 6-12 weeks postpartum
Mode of delivery
Time frame: Through study completion, about every 9-months
Child growth (weight)
Time frame: 6-12 weeks postpartum
Child growth (head circumference)
Time frame: 6-12 weeks postpartum
Child growth (height)
Time frame: 6-12 weeks postpartum
Child Major Illnesses/conditions
Time frame: Delivery to 6-12 weeks postpartum
Hospitalizations
Time frame: Delivery to 6-12 weeks postpartum
Emergency care visits
Time frame: Delivery to 6-12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 36549747Ramlawi S, Murphy MSQ, Dingwall-Harvey ALJ, Rennicks White R, Gaudet LM, McGee A, DeGrace A, Cantin C, El-Chaar D, Walker MC, Corsi DJ. Cannabis Use in Pregnancy and Downstream effects on maternal and infant health (CUPiD): a protocol for a birth cohort pilot study. BMJ Open. 2022 Dec 22;12(12):e066196. doi: 10.1136/bmjopen-2022-066196.
- Individual participant dataSharing planned: No
Related trials for Cannabis Use
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Walker, MD, MSc, MHM principal investigator
Ottawa Hospital Research Institute
Daniel Corsi, PhD principal investigator
Ottawa Hospital Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use and Marijuana Use, run by Ottawa Hospital Research Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness of eligibility criteria (time frame: Within first year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.