The Impact of Opioid and Cannabis Exposure on Fetal Growth

NCT05899101 | Terminated

• 1 other identifier: CTO 3968
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Pregnancy Related; Substance Use; Fetal Growth Retardation; Placenta Diseases

Keywords

opioid; cannabis; nicotine; opioid agonist therapy

Outcome Measures

Primary Outcomes (1)

• Birthweight

  The primary outcome of interest is difference in birthweight (grams) between the exposure groups.

  At delivery

Secondary Outcomes (7)

• Infant length

  At delivery

• Incidence of Neonatal Morbidity

  From recruitment until 6 weeks postpartum

• Length of Stay at Delivery

  From admission for delivery until discharge from hospital after delivery

• Length of Antepartum Hospital Stay

  From admission to discharge for each hospital stay that does not include delivery

• Readmission rates

  From discharge from hospital at delivery till 6 weeks postpartum

Study Arms (7)

1 - Opioid Only

Illicit and/or sustained prescription opioids only (no cannabis use)

2 - OAT Only

Opioid agonist therapy (OAT) only (no cannabis use)

3 - Opioid and Cannabis

Illicit and/or sustained prescription opioids with concurrent cannabis use

4 - OAT and Cannabis

Opioid agonist therapy (OAT) with concurrent cannabis use

5 - Nicotine Only

Nicotine users without opioid exposure

6 - Cannabis Only

Cannabis-users without opioid exposure

7 - Unexposed

Non-substance exposed healthy pregnancies

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from participating antenatal clinics at five sites across Ontario. Individuals with sustained opioid exposure during pregnancy will be eligible for inclusion into the study. Most individuals who use opioids/OATs in pregnancy smoke cigarettes (\>90%). Thus, opioid unexposed groups will also be recruited.

You may qualify if:

• Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.
• Age ≥16 years at the time of consent.
• Singleton pregnancy.
• Live fetus (documented positive fetal heart beat prior to recruitment)
• ≥18 0/7 weeks of gestation and documented anatomy ultrasound at the time of consent.
• No known significant fetal genetic abnormalities (based on genetic testing, if performed).
• 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.
• Willing to provide cord blood.
• Willing to provide placenta.
• Willing to provide urine sample for drug testing.
• Plan to reside in the study area at least until delivery.

You may not qualify if:

• Sustained use of substances other than opioids and cannabis, including methamphetamines, benzodiazepines, alcohol, and cocaine. This is defined as any use after the patient is aware that they are pregnant OR as per the discretion of the investigator.
• 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.
• Known abnormal placentation including accrete, increta and percreta.
• 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.
• 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.
• COVID-19 infection being diagnosed within 14 days of consent - recruitment may be delayed until required isolation period is over.

Sponsors & Collaborators

• Dr. Laura Gaudet: lead
• University of Ottawa: collaborator

Study Sites (5)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Links

• Study Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placenta (fresh-frozen), Placenta (FFPE), Cord Tissue (FFPE), Membrane (FFPE), Cord Blood Serum, Cord Blood Plasma, Urine

MeSH Terms

Conditions

Substance-Related Disorders; Fetal Growth Retardation; Placenta Diseases; Marijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Gaudet, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 12, 2023
• Study Start: September 23, 2022
• Primary Completion: October 15, 2024
• Study Completion: November 30, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Up to 25 Years
• Access Criteria: The IMPACT Biobank Management Committee (IBMC) makes its decisions, including decisions relating to the future direction of the IMPACT Biobank, on the basis of these standards, objectives and the best available scientific evidence. Only research studies that entail, at most, a minimal risk to Participants will be granted access to the IMPACT Biobank. The criteria for granting access include: * feasibility; * scientific value; * minimal risk; * availability of Material; * contribution to the IMPACT Research Study; * public health importance to Canadians. The IMPACT Biobank is managed on a not-for-profit basis. The IBMC sets access fees with a view to covering the costs of operating the IMPACT Biobank. To help preserve the integrity and volume of the specimens for future users, part of the access fees will pay for the micro-aliquoting of specimens.

Locations

CA (5)