About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
MyPath Intervention
BehavioralMyPath is a novel patient-centered, reproductive planning decision support tool developed by the research team used to facilitate postpartum contraceptive decision-making among women with SUDs. Designed to facilitate high-quality decisions regarding pregnancy and contraception, MyPath helps women a) review their thoughts about pregnancy and children, b) learn about fertility and preconception health and c) prioritize their preferences for various contraceptive method characteristics (e.g. effectiveness, side effects). As such, MyPath uses a patient-centered approach to help women frame their contraceptive decisions in the context of their goals and health and is a critical first step towards addressing reproductive health inequities among women with SUDs.
Usual care
BehavioralStandard of Care
Treatment groups
Trial outcomes
Primary outcomes
Contraceptive method continuation
Contraceptive method continuation as measured at each postpartum follow-up assessment by participants use of the same contraceptive method as she did at the previous timepoint.
Continuous contraceptive use
Continuous contraceptive use as measured by participants continuously using any moderately (i.e., pill, patch, or ring, injection) or highly effective (i.e., long-acting reversible contraceptive (LARC), tubal ligation) method at consecutive timepoints. Reasons for stopping or switching methods will also be obtained.
Secondary outcomes
Use of moderate or highly effective method
Use of moderate or highly effective method as measured by participants who select any moderately (i.e., pill, patch, or ring, injection) or highly effective (i.e., long-acting reversible contraceptive (LARC), tubal ligation) method at any timepoint.
Unintended pregnancy
Rate of unintentional pregnancy as measured by number of women having a new pregnancy, evaluation of intendedness of that pregnancy with the 6-item London Measure of Unplanned Pregnancy (LMUP).
Interpregnancy interval
Time-to-next pregnancy as measured by time-to-event analyses.
Decisional Conflict
Decisional conflict as measured by the Decision Conflict Scale (DCS).
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator