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OpenTrials
Completed

NCT Number: NCT06415942

Assessing the Maternal Outcome Monitoring Systems

Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Prebyterian/Weill Cornell Medical Center, New York, United States

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About this study

Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than 28 weeks pregnant
  • Receiving healthcare in the United States
  • Age 18 years or older
  • [Identify as Black or African American race AND able to speak and read English, AND preferred language of English] OR [Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish]
  • Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital

Exclusion criteria

  • Severe cognitive impairment
  • Major psychiatric illness
  • Concomitant terminal illness that would preclude participation.

Treatment and study plan

Maternal Outcome Monitoring and Support system

Other

The Maternal Outcome Monitoring and Support system is a mobile health application that allows participants to choose symptoms they may be having that are warning signs of pregnancy related death. They then receive decision support about when they should seek medical care (call their provider or go to an emergency room).

Primary outcomes

  1. Patient activation

    Time frame: Baseline to 6 weeks postpartum

    Change in patient activation measured using the validated Patient Activation Measure (PAM)

Secondary outcomes

  1. Knowledge of pregnancy related death warning signs

    Time frame: Baseline to 6 weeks postpartum

    Change in knowledge of warning signs for pregnancy related death

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Single Arm Clinical Trial of a Novel Smartphone-based Somatic and Psychological Symptom Monitoring and Decision Support Tool for African American and Spanish Speaking Patients in the Near Postpartum Period

Acronym: MOMS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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