Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)

December 29, 2025 updated by: Evan Shalen, Oregon Health and Science University
The purpose of this study is to develop a pilot screening protocol, comparing cardiac point-of-care ultrasound (POCUS), electrocardiogram (EKG), serum biomarkers (N-terminal pro b-type natriuretic peptide (NT-proBNP), high sensitivity troponin (hsTn)) with formal transthoracic echocardiogram (TTE) in pregnant women with methamphetamine use.

Study Overview

Status

Not yet recruiting

Detailed Description

This is a pilot study that examines previously undiagnosed cardiac pathology utilizing transthoracic echocardiogram (TTE) in pregnant women with chronic methamphetamine use and assesses possible screening modalities (cardiac point-of-care ultrasound (POCUS), serum biomarkers, electrocardiogram (EKG)) in identifying underlying disease in this population. As this is a prospective observational study, we will assess pregnancy-related complications and care connections in the pilot tertiary academic setting.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pregnant women > or equal to 20 weeks gestation presenting to OHSU for hospital, day patient, or observation admission will be identified via the electronic medical record.

Description

Inclusion Criteria:

  • 18 years or older > 20 weeks gestation admitted to the hospital
  • Active patient-defined regular methamphetamine use for at least 1 year and any use within the last month
  • Able to understand and provide informed consent
  • Able to understand English

Exclusion Criteria:

These criteria will exclude women whose medications, personal traits, obstetric conditions, or diseases could confound cardiovascular risk.

  • Prescribed stimulants
  • Echocardiogram or EKG previously performed during current pregnancy
  • Previous diagnosis of congestive heart dysfunction
  • Previous diagnosis of pulmonary hypertension
  • Previous myocardial infarction
  • Previous diagnosis of endocarditis
  • Prior cardiac intervention (repair of cardiac congenital lesion, valve replacement or repairs, percutaneous/operative treatment of arrhythmias)
  • High-risk aortopathy (Marfan syndrome, bicuspid aortopathy, prior aortic dissection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of point of care cardiac ultrasound for the detection of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram.
Time Frame: Day 1
This outcome seeks to identify the sensitivity of point of care cardiac ultrasound for the identification of left ventricular systolic dysfunction in pregnant people who use methamphetamine when performed by an obstetrics provider, as compared to formal transthoracic echocardiogram.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy and delivery outcomes in people who use methamphetamine
Time Frame: 3 months postpartum
This outcome seeks to identify the prevalence of pregnancy delivery complications in people who use methamphetamine.
3 months postpartum
Changes to pregnancy-related treatment plan based on cardiovascular screening in people who use methamphetamine.
Time Frame: 3 months postpartum
This outcome seeks to identify linkage to cardiovascular and addiction specialty care among patients diagnosed with cardiovascular disease.
3 months postpartum
Sensitivity of cardiac biomarkers and ECG for the identification of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram. methamphetamine
Time Frame: Day 1
This outcome seeks to identify the sensitivity of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitivity troponin and electrocardiogram for the identification of left ventricular systolic dysfunction in pregnant people who use methamphetamine, as compared to formal transthoracic echocardiogram.
Day 1
Prevalence of underlying structural heart disease in pregnant people who use methamphetamine
Time Frame: Day 1
This outcome seeks to identify the prevalence of structural heart disease in pregnant people who use methamphetamine.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Estimated)

December 30, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00028946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Methamphetamine Abuse

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