Phase
Condition
Opioid Use Disorder
Birth Defects
Stimulant Use Disorder
Treatment
N/AClinical Study ID
Ages > 16 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant who, in the opinion of the investigator, can and will comply with therequirements of the protocol.
Participant has given written consent after study has been explained according tolocal 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, ifperformed).
No significant congenital malformations (such as abnormal fetal morphology, abnormalamniotic fluid levels, significant abnormalities in placenta or umbilical cord), asassessed by fetal anomaly ultrasound scan (also known as a level 2 ultrasound orfetal 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.
Exclusion
Exclusion Criteria:
Sustained use of substances other than opioids and cannabis, includingmethamphetamines, benzodiazepines, alcohol, and cocaine. This is defined as any useafter the patient is aware that they are pregnant OR as per the discretion of theinvestigator.
Acute or chronic clinically significant abnormality or poorly controlledpre-existent co-morbidities or any other clinical conditions, as determined byphysical examination or standard of care laboratory tests, that, in the opinion ofthe investigator, might confound study results.
Known abnormal placentation including accrete, increta and percreta.
Any conditions that, in the Investigator's judgement, may interfere withparticipant'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 studyperiod, in which the participant has been or will be exposed to an investigationalor a non-investigational vaccine/product.
COVID-19 infection being diagnosed within 14 days of consent - recruitment may bedelayed until required isolation period is over.
Study Design
Study Description
Connect with a study center
Hamilton Health Sciences
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston, Ontario K7L2V7
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 5A5
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H8L6
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
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