Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899101
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-05-19
Brief Title:
The Impact of Opioid and Cannabis Exposure on Fetal Growth
Sponsor:
Dr Laura Gaudet
Organization:
Queens University
Study Overview
Official Title:
IMPACT A Prospective Cohort Study of the Impact of Opioid and Cannabis Exposure on Fetal Growth
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None