The Impact of Opioid and Cannabis Exposure on Fetal Growth

Last updated: March 17, 2025
Sponsor: Dr. Laura Gaudet
Overall Status: Terminated

Phase

N/A

Condition

Opioid Use Disorder

Birth Defects

Stimulant Use Disorder

Treatment

N/A

Clinical Study ID

NCT05899101
CTO 3968
  • Ages > 16
  • Female
  • Accepts Healthy Volunteers

Study Summary

Individually, both opioid and cannabis exposure during pregnancy are associated with changes in fetal growth. The extent to which opioid and cannabis exposure affect fetal growth is unknown. The Investigators hypothesize that the combination of both substances will impact placental function and subsequent fetal growth more severely than either substance alone. The primary objective is to determine the extent to which fetal growth profiles in opioid-exposed pregnancies are influenced by cannabis exposure. This prospective cohort study will consist of opioid-exposed pregnancies and pregnancies without opioid exposure recruited from 5 obstetrical clinics from across Ontario. A total of 546 participants will be recruited.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant who, in the opinion of the investigator, can and will comply with therequirements of the protocol.

  2. Participant has given written consent after study has been explained according tolocal 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, ifperformed).

  8. No significant congenital malformations (such as abnormal fetal morphology, abnormalamniotic fluid levels, significant abnormalities in placenta or umbilical cord), asassessed by fetal anomaly ultrasound scan (also known as a level 2 ultrasound orfetal 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

Exclusion Criteria:

  1. Sustained use of substances other than opioids and cannabis, includingmethamphetamines, benzodiazepines, alcohol, and cocaine. This is defined as any useafter the patient is aware that they are pregnant OR as per the discretion of theinvestigator.

  2. Acute or chronic clinically significant abnormality or poorly controlledpre-existent co-morbidities or any other clinical conditions, as determined byphysical examination or standard of care laboratory tests, that, in the opinion ofthe 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 withparticipant'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 studyperiod, in which the participant has been or will be exposed to an investigationalor a non-investigational vaccine/product.

  6. COVID-19 infection being diagnosed within 14 days of consent - recruitment may bedelayed until required isolation period is over.

Study Design

Total Participants: 20
Study Start date:
September 23, 2022
Estimated Completion Date:
November 30, 2024

Study Description

As cannabis exposure is prevalent in opioid-exposed pregnancies (36-75%), it is vital to understand the potential additive effect of these two concurrent exposures on the development and health of the feto-placental unit. This information would allow for informed decision making about cannabis use and can serve as an important starting point in the design of effective harm reduction strategies in this patient population. From our professional experience, the majority of opioid-using pregnant individuals are motivated to make lifestyle modifications. Eliminating cannabis may be a realistic change these individuals can make to improve outcomes for their infants.

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.

Connect with a study center

  • Hamilton Health Sciences

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L2V7
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1H8L6
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

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