Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among … (NCT04939012) | Clinical Trial Compass
RecruitingNot Applicable
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
United States400 participantsStarted 2022-10-11
Plain-language summary
This is a study to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 research site.
* 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 research site.
* 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.
* PPC ONLY: Documented tubal ligation or hysterectomy procedures at time of delivery hospitalization
What they're measuring
1
Contraceptive method continuation
Timeframe: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
2
Continuous contraceptive use
Timeframe: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery