The Impact of Opioid and Cannabis Exposure on Fetal Growth (NCT05899101) | Clinical Trial Compass
TerminatedNot Applicable
The Impact of Opioid and Cannabis Exposure on Fetal Growth
Stopped: Due to challenges with participant recruitment the propsective study was terminated.
Canada20 participantsStarted 2022-09-23
Plain-language 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.
Who can participate
Age range16 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✕. 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.