Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05309226 |
|
Recruitment Status :
Not yet recruiting
First Posted : April 4, 2022
Last Update Posted : September 21, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Cannabis Use Marijuana Use | Other: Cannabis use in pregnancy or cannabis exposure in utero |
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 prior to 20 weeks gestation 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 |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cannabis Use in Pregnancy and Downstream Effects on Maternal and Infant Health (CUPiD): A Pilot Prospective Cohort Study |
| Estimated Study Start Date : | October 2022 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2024 |
| 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.
|
- 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
- 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))
- Fetal and neonatal morbidity (sga) [ Time Frame: Throughout pregnancy until 6-12 weeks postpartum ]Rates of: small for gestational age (<10th and <3rd percentiles)
- Neonatal morbidity (NICU) [ Time Frame: Throughout pregnancy until 6-12 weeks postpartum ]Rates of: neonatal ICU admission
- Neonatal morbidity (apgar) [ Time Frame: Throughout pregnancy until 6-12 weeks postpartum ]Rates of: low Apgar (<4 at 5 min)
- Fetal and neonatal morbidity [ Time Frame: Throughout pregnancy until 6-12 weeks postpartum ]Rates of: stillbirth, spontaneous abortion, elective termination
- Maternal morbidity [ Time Frame: Throughout pregnancy until 6-12 weeks postpartum ]Rates of: gestational diabetes, pre-eclampsia, placental abruption
- Mode of delivery [ Time Frame: Through study completion, about every 9-months ]Rates of cesarean sections and vaginal deliveries
- Child growth (weight) [ Time Frame: 6-12 weeks postpartum ]weight
- Child growth (head circumference) [ Time Frame: 6-12 weeks postpartum ]head circumference
- Child growth (height) [ Time Frame: 6-12 weeks postpartum ]length
- Child Major Illnesses/conditions [ Time Frame: Delivery to 6-12 weeks postpartum ]Proportion of children receiving diagnoses of major illness/conditions
- Hospitalizations [ Time Frame: Delivery to 6-12 weeks postpartum ]Proportion of mothers and infants re-admitted to hospital
- Emergency care visits [ Time Frame: Delivery to 6-12 weeks postpartum ]Proportion of mothers and infants with emergency care visits
Biospecimen Retention: Samples Without DNA
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
- Be ≤ 20 weeks' gestation on the day of enrollment.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05309226
| Contact: Alysha Harvey, MSc, PMP | 613-737-8899 ext 73838 | alyharvey@ohri.ca | |
| Contact: Serine Ramlawi, MSc | 613-737-8899 | sramlawi@ohri.ca |
| Canada, Ontario | |
| Kingston Health Sciences Centre | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Laura Gaudet, MD laura.gaudet@kingstonhsc.ca | |
| Contact: Jessica Pudwell, MSc, MPH jessica.pudwell@queensu.ca | |
| Principal Investigator: Laura Gaudet, MD | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Serine Ramlawi, MSc 613-737-8899 sramlawi@ohri.ca | |
| Contact: Alysha Harvey, MSc, PMP 613-737-8899 ext 73838 alyharvey@ohri.ca | |
| Principal Investigator: Daniel Corsi, PhD | |
| The Ottawa Hospital - Civic Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Serine Ramlawi, MSc 613-737-8899 sramlawi@ohri.ca | |
| Contact: Alysha Harvey, MSc, PMP 613-737-8899 ext 73838 alyharvey@ohri.ca | |
| Principal Investigator: Mark Walker, MD, MSc, MHM | |
| Sub-Investigator: Daniel Corsi, PhD | |
| The Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Serine Ramlawi, MSc 613-737-8899 sramlawi@ohri.ca | |
| Contact: Alysha Harvey, MSc, PMP 613-737-8899 ext 73838 alyharvey@ohri.ca | |
| Principal Investigator: Mark Walker, MD, MSc, MHM | |
| Sub-Investigator: Daniel Corsi, PhD | |
| Principal Investigator: | Mark Walker, MD, MSc, MHM | Ottawa Hospital Research Institute | |
| Principal Investigator: | Daniel Corsi, PhD | Ottawa Hospital Research Institute |
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT05309226 |
| Other Study ID Numbers: |
CTO 3791 |
| First Posted: | April 4, 2022 Key Record Dates |
| Last Update Posted: | September 21, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
perinatal cannabis pregnancy marijuana |
|
Marijuana Abuse Marijuana Use Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |