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

Cannabis Use Clinical Trial

— CUPiD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309226
• Other study ID #: CTO 3791
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Ottawa Hospital Research Institute
• Contact: Alysha Harvey, MSc, PMP
• Phone: 613-737-8899
• Email: alyharvey[@]ohri.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse
• Marijuana Use

Intervention

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.).

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Children's Hospital of Eastern Ontario Research Institute, Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriateness of eligibility criteria	Measured by the reasons for exclusion of screened subjects	Within first year
Primary	Recruitment rate	Measured by the proportion of eligible cases and controls recruited into the cohort	Within first year
Primary	Level of engagement	Measured by the proportion of recruited subjects contributing data and biospecimens at each time point	Within first year
Primary	Protocol compliance	Measured by attrition rate (loss to follow-up or withdrawal of consent) of enrolled subjects	Within first year
Primary	Appropriateness of sample size and time frame	Measured by the timeframe required to recruit target sample size	Within first year
Secondary	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
Secondary	Fetal and neonatal morbidity (sga)	Rates of: small for gestational age (<10th and <3rd percentiles)	Throughout pregnancy until 6-12 weeks postpartum
Secondary	Neonatal morbidity (NICU)	Rates of: neonatal ICU admission	Throughout pregnancy until 6-12 weeks postpartum
Secondary	Neonatal morbidity (apgar)	Rates of: low Apgar (<4 at 5 min)	Throughout pregnancy until 6-12 weeks postpartum
Secondary	Fetal and neonatal morbidity	Rates of: stillbirth, spontaneous abortion, elective termination	Throughout pregnancy until 6-12 weeks postpartum
Secondary	Maternal morbidity	Rates of: gestational diabetes, pre-eclampsia, placental abruption	Throughout pregnancy until 6-12 weeks postpartum
Secondary	Mode of delivery	Rates of cesarean sections and vaginal deliveries	Through study completion, about every 9-months
Secondary	Child growth (weight)	weight	6-12 weeks postpartum
Secondary	Child growth (head circumference)	head circumference	6-12 weeks postpartum
Secondary	Child growth (height)	length	6-12 weeks postpartum
Secondary	Child Major Illnesses/conditions	Proportion of children receiving diagnoses of major illness/conditions	Delivery to 6-12 weeks postpartum
Secondary	Hospitalizations	Proportion of mothers and infants re-admitted to hospital	Delivery to 6-12 weeks postpartum
Secondary	Emergency care visits	Proportion of mothers and infants with emergency care visits	Delivery to 6-12 weeks postpartum