- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309757
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
Conditions
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
- Name: Evan Shalen, MD
- Phone Number: 503-494-1775
- Email: shalen@ohsu.edu
Study Contact Backup
- Name: Sara McCrimmon
- Email: mccrimmo@ohsu.edu
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
Keywords
Additional Relevant MeSH Terms
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.
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