Pregnancy RelatedIMPACTNCT05899101
The Impact of Opioid and Cannabis Exposure on Fetal Growth
An observational study of Pregnancy Related and Substance Use, run by Dr. Laura Gaudet at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Substance Use, Fetal Growth Retardation
- How many people
- 20 participants
- Where
- 5 sitesCanada
- Study dates
- 23 Sep 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
London Health Sciences Centre
London, Ontario, N6A 5A5
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: IMPACT: A Prospective Cohort Study of the Impact of Opioid and Cannabis Exposure on Fetal Growth
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.
Read the detailed 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.
- Keywords
- opioid, cannabis, nicotine, opioid agonist therapy
- Medical subject headings
- Substance-Related Disorders, Fetal Growth Retardation, Placenta Diseases, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birthweight
The primary outcome of interest is difference in birthweight (grams) between the exposure groups.
Measured: At delivery
Secondary outcomes (7)
Infant length
Infant length at birth (cm) will be compared between the groups.
Measured: At delivery
Incidence of Neonatal Morbidity
The incidence of neonatal morbidity will be compared between the groups. Severe neonatal morbidity (SNM) will be defined as the presence of at least one of the following elements: Apgar score < 4 at 5 min or severe respiratory distress requiring respiratory support, severe neonatal acidosis (cord artery pH < 7.0 or base excess <-12 mmol/L), admission to the neonatal intensive care unit (NICU), cystic periventricular leukomalacia (cPVL), intraventricular haemorrhage (IVH grades III and IV), surgical necrotizing enterocolitis (NEC requiring surgical treatment or peritoneal drainage) or retinopathy of prematurity (ROP≥stage 3).
Measured: From recruitment until 6 weeks postpartum
Length of Stay at Delivery
Length of hospital stay in hours for delivery between the groups. This will be measured from the date of admission to delivery till the date of discharge from the hospital after delivery.
Measured: From admission for delivery until discharge from hospital after delivery
Length of Antepartum Hospital Stay
Length of antepartum hospital admissions in hours between the groups. This will be measured from the date of admission to the date of discharge for any maternal hospital admissions before the admission for delivery.
Measured: From admission to discharge for each hospital stay that does not include delivery
Readmission rates
Readmission rates between the groups
Measured: From discharge from hospital at delivery till 6 weeks postpartum
Placental Weight
Placental weight (grams) between the groups.
Measured: At delivery
Placental gene expression profiles
Placental gene expression profiles related to vascular development, nutrient transport and metabolic signaling between the groups. These will be assessed using RNA sequencing and spatial transcriptomics.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start23 Sep 2022
- Primary completion15 Oct 2024
- Study completion30 Nov 2024
Why it stopped: Due to challenges with participant recruitment the propsective study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Laura Gaudet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor-investigator, Dr. Laura Gaudet, Queen's University
- Investigators
- Laura Gaudet, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899101
- Sponsor's protocol ID
- CTO 3968
- Acronym
- IMPACT
- Status last verified
- Mar 2025
- First submitted
- 19 May 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The objectives of the IMPACT Biobank are to provide a basis for future research on pregnancy and newborn health. The IMPACT consent for Future Research on Stored Biological Samples obtained from Participants is broad enough to support a range of research on fetal growth, pregnancy and the health of mothers and their children. Biobanking is an optional part of the IMPACT study. Participants may decide not to participate in the optional biobanking research and still participate in the main study. The IMPACT Biobank is managed in accordance with the principles set forth in: * The Canadian Charter of Rights and Freedoms * The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects * The Universal Declaration on Bioethics and Human Rights * The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans * The Canadian Institutes of Health Research Best Practices for Protecting Privacy in Health Research
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: A Prospective Cohort Study of the Impact of Opioid and Cannabis Exposure on Fetal Growth
- ClinicalTrials.gov ID
- NCT05899101
- Acronym / sponsor ID
- IMPACT / CTO 3968
- Keywords
- opioid, cannabis, nicotine, opioid agonist therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to challenges with participant recruitment the propsective study was terminated.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Laura GaudetUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birthweight
Time frame: At delivery
The primary outcome of interest is difference in birthweight (grams) between the exposure groups.
7 secondary outcomes
Infant length
Time frame: At delivery
Incidence of Neonatal Morbidity
Time frame: From recruitment until 6 weeks postpartum
Length of Stay at Delivery
Time frame: From admission for delivery until discharge from hospital after delivery
Length of Antepartum Hospital Stay
Time frame: From admission to discharge for each hospital stay that does not include delivery
Readmission rates
Time frame: From discharge from hospital at delivery till 6 weeks postpartum
Placental Weight
Time frame: At delivery
Placental gene expression profiles
Time frame: At delivery
Results and safety
The study was stopped early (reason given: Due to challenges with participant recruitment the propsective study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Yes. The objectives of the IMPACT Biobank are to provide a basis for future research on pregnancy and newborn health. The IMPACT consent for Future Research on Stored Biological Samples obtained from Participants is broad enough to support a range of research on fetal growth, pregnancy and the health of mothers and their children. Biobanking is an optional part of the IMPACT study. Participants may decide not to participate in the optional biobanking research and still participate in the main study. The IMPACT Biobank is managed in accordance with the principles set forth in: * The Canadian Charter of Rights and Freedoms * The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects * The Universal Declaration on Bioethics and Human Rights * The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans * The Canadian Institutes of Health Research Best Practices for Protecting Privacy in Health Research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Gaudet, MD principal investigator
Queen's University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Substance Use, run by Dr. Laura Gaudet at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to challenges with participant recruitment the propsective study was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birthweight (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.