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

NCT04939012 | Recruiting DMC

• 2 other identifiers: STUDY201103241R01DA051674-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorders; Pregnancy Related; Contraception

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• Use of moderate or highly effective method

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

• Unintended pregnancy

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

• Interpregnancy interval

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

• Decisional Conflict

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

• Values concordance

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

Study Arms (2)

MyPath Intervention

EXPERIMENTAL

At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.

Behavioral: MyPath Intervention

Standard of Care

ACTIVE COMPARATOR

At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

Behavioral: Usual care

Interventions

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.

MyPath Intervention

Usual care BEHAVIORAL

Standard of Care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elizabeth Krans, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Krans, MD

CONTACT

(412) 641-3532; kransee@upmc.edu

Samantha Mayo, BA

CONTACT

(412) 641-2248; mayos@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 25, 2021
• Study Start: October 11, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)