Clinical trial NCT05309226: Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health
Official title: Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD): A Pilot Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use
Marijuana Use
Keywords: perinatal
cannabis
pregnancy
marijuana
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Kingston Health Sciences Centre
name: Children's Hospital of Eastern Ontario Research Institute
First posted: 2022-04-04
Enrollment: 43
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appropriateness of eligibility criteria
timeFrame: Within first year
measure: Recruitment rate
timeFrame: Within first year
measure: Level of engagement
timeFrame: Within first year
measure: Protocol compliance
timeFrame: Within first year
measure: Appropriateness of sample size and time frame
timeFrame: Within first year
Secondary outcomes:
measure: Fetal and neonatal morbidity (preterm)
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Fetal and neonatal morbidity (sga)
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Neonatal morbidity (NICU)
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Neonatal morbidity (apgar)
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Fetal and neonatal morbidity
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Maternal morbidity
timeFrame: Throughout pregnancy until 6-12 weeks postpartum
measure: Mode of delivery
timeFrame: Through study completion, about every 9-months
measure: Child growth (weight)
timeFrame: 6-12 weeks postpartum
measure: Child growth (head circumference)
timeFrame: 6-12 weeks postpartum
measure: Child growth (height)
timeFrame: 6-12 weeks postpartum
measure: Child Major Illnesses/conditions
timeFrame: Delivery to 6-12 weeks postpartum
measure: Hospitalizations
timeFrame: Delivery to 6-12 weeks postpartum
measure: Emergency care visits
timeFrame: Delivery to 6-12 weeks postpartum
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Mark Walker, MD, MSc, MHM
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Daniel Corsi, PhD
role: PRINCIPAL_INVESTIGATOR
References: