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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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