Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pittsburgh

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MyPath Intervention

    Behavioral

    MyPath 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

    Behavioral

    Standard of Care

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: MyPath InterventionExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
2

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.

Time frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery

Secondary outcomes

1

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.

Time frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
2

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).

Time frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
3

Interpregnancy interval

Time-to-next pregnancy as measured by time-to-event analyses.

Time frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
4

Decisional Conflict

Decisional conflict as measured by the Decision Conflict Scale (DCS).

Time frame
Enrollment (22 - 37 weeks pregnant) to 18 months post delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator