Substance Use DisordersIMPACTNCT04939012
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
A study testing MyPath Intervention in people with Substance Use Disorders and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Disorders, Pregnancy Related, Contraception
- What is being tested?
- MyPath Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Mayo Samantha, BA, (412) 641-2248, mayos@upmc.edu
Ellen Stewart, (412) 641-4984, stewartep@upmc.edu
About this study
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.
Read the detailed description
The reproductive health needs of women with substance use disorders (SUDs) are unmet. Over 80% of pregnancies among women with SUDs are unintended, compared to 45% of the general population, and over 20% of women with SUDs have had a short interpregnancy interval (i.e. ≤ 18 months after a previous birth). Adverse reproductive health outcomes are perpetuated by contraceptive decisions that are inconsistent with women's reproductive goals. In an evaluation of women in opioid use disorder (OUD) treatment, only half of sexually active women not wanting to get pregnant used contraception, with condoms the most frequent method used. Pregnancy is a unique opportunity to address contraceptive needs due to increased healthcare access and expanded Medicaid eligibility, increased access to highly effective methods such as long-acting reversible contraception (LARC) and enhanced motivation to avoid rapid, repeat pregnancy. Despite this, over 75% of women with OUD do not use postpartum contraception and less than 2% receive LARC.
Currently, there are no effective strategies to improve postpartum contraceptive decision-making for women with SUDs. As an initial step to address this gap, the investigators conducted an observational study of postpartum contraceptive choices among 194 women with OUD at our maternity hospital (Plan NOW). Per usual care, women were provided with information about all contraceptive options, consistent with "information-based" counseling, and access to all methods including immediate postpartum LARC. Several findings informed this proposal. First, women's postpartum contraceptive decisions were often inconsistent with their childbearing goals. Among women who did not want another child, 36% did not choose a highly effective method and 10% had a repeat pregnancy within one year. Second, women had limited contraceptive knowledge and frequent misconceptions about their fertility and vulnerability to pregnancy. Third, women's decisional autonomy regarding sex and contraception was often threatened due to ongoing illicit drug use and reproductive coercion by partners. Fourth, women who wanted another baby did not feel supported and often felt pressured to choose a highly effective method. Therefore, failure to frame contraceptive decisions within the larger reproductive health context of women with OUD was a major barrier to high quality decision-making.
The goal of this research is to help women with SUDs make informed decisions about their reproductive health that align with their preferences, values and reproductive goals. Our objective in this application is 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. 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. Our overarching hypothesis is that patient-centered, reproductive planning decision support will facilitate high quality decision-making and thus improve postpartum contraceptive utilization and reproductive health outcomes among women with SUDs. To test this hypothesis, the investigators propose a hybrid type 1 effectiveness-implementation randomized controlled trial, guided by the following aims:
Aim 1: Assess the effect of patient-centered, reproductive planning decision support (MyPath) on postpartum contraceptive utilization and reproductive health outcomes among women with SUDs
Aim 2: Determine if the relationship between MyPath and contraceptive utilization is mediated by decision quality. Decision quality will be measured using four patient-centered components of decision-making: knowledge, values concordance, decisional conflict and involvement. The investigators hypothesize that improvements in decision quality will mediate the relationship between MyPath and contraceptive utilization.
Aim 3: Identify barriers and facilitators to integrating MyPath into routine postpartum clinical care. The investigators will gather process evaluation data during the randomized controlled trial (RCT) and conduct qualitative interviews with key patient, provider and health system stakeholders to identify potential barriers and facilitators to future implementation in maternity settings and routine postpartum clinical care, if MyPath is found to be effective.
- Conditions
- Substance Use Disorders, Pregnancy Related, Contraception
- Being tested
- MyPath Intervention, Usual care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPath InterventionBehavioural
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 careBehavioural
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| MyPath Intervention | Experimental | At the first visit participants randomized to this arm receive MyPath contraceptive decision tool. Receives: Behavioral: MyPath Intervention |
| Standard of Care | Active comparator | At the first visit participants randomized to this arm receive standard of care contraceptive counseling. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Secondary outcomes (7)
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.
Measured: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
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).
Measured: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Interpregnancy interval
Time-to-next pregnancy as measured by time-to-event analyses.
Measured: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Decisional Conflict
Decisional conflict as measured by the Decision Conflict Scale (DCS).
Measured: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Values concordance
We will measure women's perceptions of the values concordance of their selected postpartum contraceptive method as measured by a two-item adapted Measure of the Alignment of Choices (MATCH)
Measured: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Knowledge
Reproductive planning knowledge as measured by an 18-item reproductive planning knowledge scale adapted from validated contraceptive knowledge assessments.
Measured: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Involvement
Involvement in decision making as measured by the Interpersonal Quality in Family Planning care (IQFP).
Measured: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start11 Oct 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elizabeth Krans, MD, University of Pittsburgh
- Investigators
- Elizabeth Krans, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939012
- Sponsor's protocol ID
- STUDY20110324
- Other IDs
- 1R01DA051674-01A1
- Acronym
- IMPACT
- Status last verified
- Feb 2026
- First submitted
- 23 Jun 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The University of Pittsburgh study investigators will be responsible for publication of the results of this study. A publication plan according to the intellectual and scientific contribution of each member of the investigative team will be agreed upon prior to publication of study results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
- ClinicalTrials.gov ID
- NCT04939012
- Acronym / sponsor ID
- IMPACT / STUDY20110324
- Conditions
- Substance Use Disorders, Pregnancy Related, Contraception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The reproductive health needs of women with substance use disorders (SUDs) are unmet. Over 80% of pregnancies among women with SUDs are unintended, compared to 45% of the general population, and over 20% of women with SUDs have had a short interpregnancy interval (i.e. ≤ 18 months after a previous birth). Adverse reproductive health outcomes are perpetuated by contraceptive decisions that are inconsistent with women's reproductive goals. In an evaluation of women in opioid use disorder (OUD) treatment, only half of sexually active women not wanting to get pregnant used contraception, with condoms the most frequent method used. Pregnancy is a unique opportunity to address contraceptive needs due to increased healthcare access and expanded Medicaid eligibility, increased access to highly effective methods such as long-acting reversible contraception (LARC) and enhanced motivation to avoid rapid, repeat pregnancy. Despite this, over 75% of women with OUD do not use postpartum contraception and less than 2% receive LARC.
Currently, there are no effective strategies to improve postpartum contraceptive decision-making for women with SUDs. As an initial step to address this gap, the investigators conducted an observational study of postpartum contraceptive choices among 194 women with OUD at our maternity hospital (Plan NOW). Per usual care, women were provided with information about all contraceptive options, consistent with "information-based" counseling, and access to all methods including immediate postpartum LARC. Several findings informed this proposal. First, women's postpartum contraceptive decisions were often inconsistent with their childbearing goals. Among women who did not want another child, 36% did not choose a highly effective method and 10% had a repeat pregnancy within one year. Second, women had limited contraceptive knowledge and frequent misconceptions about their fertility and vulnerability to pregnancy. Third, women's decisional autonomy regarding sex and contraception was often threatened due to ongoing illicit drug use and reproductive coercion by partners. Fourth, women who wanted another baby did not feel supported and often felt pressured to choose a highly effective method. Therefore, failure to frame contraceptive decisions within the larger reproductive health context of women with OUD was a major barrier to high quality decision-making.
The goal of this research is to help women with SUDs make informed decisions about their reproductive health that align with their preferences, values and reproductive goals. Our objective in this application is 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. 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. Our overarching hypothesis is that patient-centered, reproductive planning decision support will facilitate high quality decision-making and thus improve postpartum contraceptive utilization and reproductive health outcomes among women with SUDs. To test this hypothesis, the investigators propose a hybrid type 1 effectiveness-implementation randomized controlled trial, guided by the following aims:
Aim 1: Assess the effect of patient-centered, reproductive planning decision support (MyPath) on postpartum contraceptive utilization and reproductive health outcomes among women with SUDs
Aim 2: Determine if the relationship between MyPath and contraceptive utilization is mediated by decision quality. Decision quality will be measured using four patient-centered components of decision-making: knowledge, values concordance, decisional conflict and involvement. The investigators hypothesize that improvements in decision quality will mediate the relationship between MyPath and contraceptive utilization.
Aim 3: Identify barriers and facilitators to integrating MyPath into routine postpartum clinical care. The investigators will gather process evaluation data during the randomized controlled trial (RCT) and conduct qualitative interviews with key patient, provider and health system stakeholders to identify potential barriers and facilitators to future implementation in maternity settings and routine postpartum clinical care, if MyPath is found to be effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyPath Intervention | Experimental | Behavioral: MyPath InterventionAt the first visit participants randomized to this arm receive MyPath contraceptive decision tool. |
| Standard of Care | Active comparator | Behavioral: Usual careAt the first visit participants randomized to this arm receive standard of care contraceptive counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Be greater than or equal to 18 years of age.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPath InterventionMyPath 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. | Behavioural | MyPath Intervention |
| Usual careStandard of Care | Behavioural | Standard of Care |
Primary outcome
Contraceptive method continuation
Time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
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
Time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
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.
7 secondary outcomes
Use of moderate or highly effective method
Time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Unintended pregnancy
Time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Interpregnancy interval
Time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Decisional Conflict
Time frame: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Values concordance
Time frame: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Knowledge
Time frame: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Involvement
Time frame: Enrollment (22 - 37 weeks pregnant) to 18 months post delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. The University of Pittsburgh study investigators will be responsible for publication of the results of this study. A publication plan according to the intellectual and scientific contribution of each member of the investigative team will be agreed upon prior to publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Krans, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPath Intervention in people with Substance Use Disorders and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Krans, MD ((412) 641-3532, kransee@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive method continuation (time frame: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.