Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT04939012

Conditions

Substance Use Disorders

Pregnancy Related

Contraception

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MyPath Intervention

Usual care

Study Details

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

Study ID

NCT04939012

Start date

Oct 11, 2022

Status verified date

Feb, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: MyPath Intervention

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

active comparator: Standard of Care

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

Interventions

MyPath Intervention

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

Standard of Care

Primary outcome measure

  • Contraceptive method continuation [ Time Frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery ]
  • Continuous contraceptive use [ Time Frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery ]

Central Contacts and Locations

Central contacts

Elizabeth Krans, MD

(412) 641-3532kransee@upmc.edu

Samantha Mayo, BA

(412) 641-2248mayos@upmc.edu

Locations

Magee Womens Hospital of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Mayo Samantha, BA

(412) 641-2248mayos@upmc.edu

Ellen Stewart

(412) 641-4984stewartep@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-17.