Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD)

July 9, 2023 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alysha Harvey, MSc, PMP
  • Phone Number: 73838 613-737-8899
  • Email: alyharvey@ohri.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Walker, MD, MSc, MHM
        • Sub-Investigator:
          • Daniel Corsi, PhD
      • Ottawa, Ontario, Canada, K1H 8L1
        • Not yet recruiting
        • Children's Hospital Of Eastern Ontario
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Corsi, PhD
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - Civic Campus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Walker, MD, MSc, MHM
        • Sub-Investigator:
          • Daniel Corsi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.).
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
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.).
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness of eligibility criteria
Time Frame: Within first year
Measured by the reasons for exclusion of screened subjects
Within first year
Recruitment rate
Time Frame: Within first year
Measured by the proportion of eligible cases and controls recruited into the cohort
Within first year
Level of engagement
Time Frame: Within first year
Measured by the proportion of recruited subjects contributing data and biospecimens at each time point
Within first year
Protocol compliance
Time Frame: Within first year
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
Time Frame: Within first year
Measured by the timeframe required to recruit target sample size
Within first year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity (sga)
Time Frame: Throughout pregnancy until 6-12 weeks postpartum
Rates of: small for gestational age (<10th and <3rd percentiles)
Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (NICU)
Time Frame: Throughout pregnancy until 6-12 weeks postpartum
Rates of: neonatal ICU admission
Throughout pregnancy until 6-12 weeks postpartum
Neonatal morbidity (apgar)
Time Frame: Throughout pregnancy until 6-12 weeks postpartum
Rates of: low Apgar (<4 at 5 min)
Throughout pregnancy until 6-12 weeks postpartum
Fetal and neonatal morbidity
Time Frame: Throughout pregnancy until 6-12 weeks postpartum
Rates of: stillbirth, spontaneous abortion, elective termination
Throughout pregnancy until 6-12 weeks postpartum
Maternal morbidity
Time Frame: Throughout pregnancy until 6-12 weeks postpartum
Rates of: gestational diabetes, pre-eclampsia, placental abruption
Throughout pregnancy until 6-12 weeks postpartum
Mode of delivery
Time Frame: Through study completion, about every 9-months
Rates of cesarean sections and vaginal deliveries
Through study completion, about every 9-months
Child growth (weight)
Time Frame: 6-12 weeks postpartum
weight
6-12 weeks postpartum
Child growth (head circumference)
Time Frame: 6-12 weeks postpartum
head circumference
6-12 weeks postpartum
Child growth (height)
Time Frame: 6-12 weeks postpartum
length
6-12 weeks postpartum
Child Major Illnesses/conditions
Time Frame: Delivery to 6-12 weeks postpartum
Proportion of children receiving diagnoses of major illness/conditions
Delivery to 6-12 weeks postpartum
Hospitalizations
Time Frame: Delivery to 6-12 weeks postpartum
Proportion of mothers and infants re-admitted to hospital
Delivery to 6-12 weeks postpartum
Emergency care visits
Time Frame: Delivery to 6-12 weeks postpartum
Proportion of mothers and infants with emergency care visits
Delivery to 6-12 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Queen's University
Children's Hospital of Eastern Ontario Research Institute

Investigators

  • Principal Investigator: Mark Walker, MD, MSc, MHM, Ottawa Hospital Research Institute
  • Principal Investigator: Daniel Corsi, PhD, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 9, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 3791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Marijuana Use

Clinical Trials on Cannabis use in pregnancy or cannabis exposure in utero

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe