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MyPath Intervention for Postpartum Birth Control Planning in Women with Substance Use Disorder (IMPACT Trial)

N/A

Recruiting

Led By Elizabeth Krans, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly postpartum women 18 years old+

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment (24 - 37 weeks pregnant) to 18 months post delivery

Awards & highlights

IMPACT Trial Summary

This trial will test a new tool to help women with substance abuse disorders make decisions about birth control after giving birth.

Who is the study for?

This trial is for new mothers aged 18 or older who have just given birth at Magee-Womens Hospital, speak English, and meet the criteria for substance use disorder as confirmed by medical records or urine tests. Women with fetal or neonatal death, severe psychiatric conditions requiring urgent treatment, or non-DSM-V level substance use are excluded.Check my eligibility

What is being tested?

The study is testing MyPath, a new tool designed to help postpartum women with substance use disorders make decisions about birth control. It will be compared to the usual care these women receive to see if it makes a difference in their contraceptive choices.See study design

What are the potential side effects?

Since this trial involves a decision support tool rather than medication, there are no direct side effects from interventions like drugs. However, participation may influence personal decision-making regarding reproductive planning.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a new mother and I am 18 years old or older.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment (24 - 37 weeks pregnant) to 18 months post delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment (24 - 37 weeks pregnant) to 18 months post delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment (24 - 37 weeks pregnant) to 18 months post delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Continuous contraceptive use

Contraceptive method continuation

Secondary outcome measures

Decisional Conflict

Interpregnancy interval

Involvement

+4 more

IMPACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyPath InterventionExperimental Treatment1 Intervention

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

Group II: Standard of CareActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,536 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,619,009 Total Patients Enrolled

Elizabeth Krans, MDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Media Library

MyPath Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04939012 — N/A

Substance Use Disorder Research Study Groups: MyPath Intervention, Standard of Care

Substance Use Disorder Clinical Trial 2023: MyPath Intervention Highlights & Side Effects. Trial Name: NCT04939012 — N/A

MyPath Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04939012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this research endeavor?

"Clinicaltrials.gov attests that this medical trial is no longer seeking participants, as it was last updated on 11/21/2022 since its initial posting date of 12/1/2022. Nonetheless, 543 other clinical trials are still recruiting subjects at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Elizabeth Krans, MD 2022. "Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04939012.