A tool to help women with substance use disorders make reproductive decisions after childbirth
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
This study is testing a new tool called MyPath to help women with substance use disorders make better choices about birth control after having a baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04939012 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of MyPath, a patient-centered decision support tool designed to improve postpartum contraceptive decision-making among women with substance use disorders (SUDs). The research addresses the high rates of unintended pregnancies in this population by providing tailored reproductive planning support during a critical period of increased healthcare access. Participants will receive either the MyPath intervention or usual care, with the goal of enhancing their contraceptive choices and aligning them with their reproductive goals. The study aims to fill a significant gap in postpartum care for women with SUDs, who often face barriers to effective contraceptive use.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are pregnant or within 9 days postpartum and have a substance use disorder.
Not a fit: Patients who have experienced fetal or neonatal death in their current pregnancy or are currently incarcerated may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly reduce unintended pregnancies among women with substance use disorders.
How similar studies have performed: While there is limited research specifically targeting this approach, the study builds on previous observational findings regarding contraceptive choices in women with opioid use disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Krans, MD — University of Pittsburgh
- Study coordinator: Elizabeth Krans, MD
- Email: kransee@upmc.edu
- Phone: (412) 641-3532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.