The Impact of Opioid and Cannabis Exposure on Fetal Growth

Pregnancy Related Clinical Trial

— IMPACT  

Official title:

IMPACT: A Prospective Cohort Study of the Impact of Opioid and Cannabis Exposure on Fetal Growth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899101
• Other study ID #: CTO 3968
• Status: Recruiting
• Start date: September 23, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: Jessica Pudwell, MSc, MPH
• Phone: 613-549-6666
• Email: jessica.pudwell[@]queensu.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 546
• Est. completion date: December 31, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

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:

1. 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.

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.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Placenta Diseases
• Pregnancy Related
• Substance Use
• Substance-Related Disorders

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Laura Gaudet	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birthweight	The primary outcome of interest is difference in birthweight (grams) between the exposure groups.	At delivery
Secondary	Infant length	Infant length at birth (cm) will be compared between the groups.	At delivery
Secondary	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).	From recruitment until 6 weeks postpartum
Secondary	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.	From admission for delivery until discharge from hospital after delivery
Secondary	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.	From admission to discharge for each hospital stay that does not include delivery
Secondary	Readmission rates	Readmission rates between the groups	From discharge from hospital at delivery till 6 weeks postpartum
Secondary	Placental Weight	Placental weight (grams) between the groups.	At delivery
Secondary	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.	At delivery

External Links

•   Study Website