Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health
CUPiD
1 other identifier
observational
43
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedApril 16, 2025
April 1, 2025
2.2 years
February 10, 2022
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (13)
Fetal and neonatal morbidity (preterm)
Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity (sga)
Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (NICU)
Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (apgar)
Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity
Throughout pregnancy until 6-12 weeks postpartum
- +8 more secondary outcomes
Study Arms (5)
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.
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
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.
Interventions
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.).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1H 8L6, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (1)
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.
PMID: 36549747DERIVED
Biospecimen
Consenting participants will be asked to contribute biological samples. We will allow participants to choose the scope of sample collection at each time-point. Sampling will be coordinated alongside routine clinical collections where possible to minimize burden to participants. Samples will be collected at 5 timepoints throughout the study time period: in each trimester of pregnancy, at delivery and at 6-12 weeks postpartum. Maternal blood and urine will be collected at all visits. During the delivery admission, cord blood, cord tissue, placenta, meconium, and breastmilk will be collected. At the postpartum visit, baby urine and blood (dried blood spot) and breastmilk will be collected. Partners will not be asked to contribute biological samples.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Walker, MD, MSc, MHM
Ottawa Hospital Research Institute
- PRINCIPAL INVESTIGATOR
Daniel Corsi, PhD
Ottawa Hospital Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
April 4, 2022
Study Start
October 10, 2022
Primary Completion
January 7, 2025
Study Completion
February 1, 2025
Last Updated
April 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share