Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04939012
Eligibility Criteria:
Inclusion Criteria
Prenatal Cohort:
* Be greater than or equal to 18 years of age.
* Be pregnant with an EGA of 22 to 37 weeks at enrollment.
* Plan to deliver at MWH.
* Meet DSM-5 criteria for a SUD (i.e., opioid, stimulant or other use disorder) and/or have a diagnosis code for a substance use disorder in their medical record.
Postpartum Cohort:
* Be greater than or equal to 18 years of age.
* Be 0-9 days postpartum at enrollment.
* Have delivered at MWH.
* Meet DSM-5 criteria for a SUD (i.e., opioid, stimulant or other use disorder) and/or have a diagnosis code for a substance use disorder in their medical record.
Exclusion Criteria:
* Have had a fetal or neonatal death with their current pregnancy.
* Be currently in jail or prison as required by court of law. Persons on probation or in residential facilities do not need to be excluded.
* Have any other condition (social or medical) which, in the opinion of the Investigator, would make study participation unsafe, make study participation difficult, and/or complicate data interpretation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04939012
Study Brief:
Protocol Section:
NCT04939012