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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05899101
Other study ID # CTO 3968
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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