The Impact of Opioid and Cannabis Exposure on Fetal Growth
NCT ID: NCT05899101
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
20 participants
OBSERVATIONAL
2022-09-23
2024-11-30
Brief Summary
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Detailed Description
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Individually, both opioid and cannabis exposure during pregnancy are associated with altered fetal growth. The extent to which opioid and cannabis exposure affect fetal growth trajectories is unknown. The Investigators postulate that the combination of both substances will impact placental function and subsequent fetal growth more severely than either substance alone. Delineating this relationship may allow for the development of evidence-based harm reduction strategies focused on eliminating cannabis use in opioid-exposed pregnancies to improve fetal growth.
The overarching hypothesis of this research is that opioid exposure compromises placental growth and function, with significant impacts on vascular development, nutrient transport and metabolic signaling, ultimately impacting fetal growth trajectories. The Investigators further propose that the additive effects of cannabis use, extremely common in these pregnancies, may exacerbate this placental dysfunction.
Thus, the primary objective of this study is to determine the extent to which fetal growth profiles in opioid-exposed pregnancies are influenced by cannabis exposure.
The study population will consist of opioid-exposed pregnancies recruited from 5 obstetrical clinics from across Ontario. A total of 546 participants will be recruited.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1 - Opioid Only
Illicit and/or sustained prescription opioids only (no cannabis use)
No interventions assigned to this group
2 - OAT Only
Opioid agonist therapy (OAT) only (no cannabis use)
No interventions assigned to this group
3 - Opioid and Cannabis
Illicit and/or sustained prescription opioids with concurrent cannabis use
No interventions assigned to this group
4 - OAT and Cannabis
Opioid agonist therapy (OAT) with concurrent cannabis use
No interventions assigned to this group
5 - Nicotine Only
Nicotine users without opioid exposure
No interventions assigned to this group
6 - Cannabis Only
Cannabis-users without opioid exposure
No interventions assigned to this group
7 - Unexposed
Non-substance exposed healthy pregnancies
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.
3. Age ≥16 years at the time of consent.
4. Singleton pregnancy.
5. Live fetus (documented positive fetal heart beat prior to recruitment)
6. ≥18 0/7 weeks of gestation and documented anatomy ultrasound at the time of consent.
7. No known significant fetal genetic abnormalities (based on genetic testing, if performed).
8. No significant congenital malformations (such as abnormal fetal morphology, abnormal amniotic fluid levels, significant abnormalities in placenta or umbilical cord), as assessed by fetal anomaly ultrasound scan (also known as a level 2 ultrasound or fetal morphology assessment) conducted at or beyond 18 0/7 weeks of gestation.
9. Willing to provide cord blood.
10. Willing to provide placenta.
11. Willing to provide urine sample for drug testing.
12. Plan to reside in the study area at least until delivery.
Exclusion Criteria
2. Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or standard of care laboratory tests, that, in the opinion of the investigator, might confound study results.
3. Known abnormal placentation including accrete, increta and percreta.
4. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.
5. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
6. COVID-19 infection being diagnosed within 14 days of consent - recruitment may be delayed until required isolation period is over.
16 Years
FEMALE
Yes
Sponsors
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University of Ottawa
OTHER
Dr. Laura Gaudet
OTHER
Responsible Party
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Dr. Laura Gaudet
Associate Professor
Principal Investigators
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Laura Gaudet, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Related Links
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Study Website
Other Identifiers
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CTO 3968
Identifier Type: -
Identifier Source: org_study_id
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