Assessing the Maternal Outcome Monitoring Systems (MOMS)

Columbia University

Status: Enrolling

Conditions: Maternal Complication of Pregnancy; Maternal Death

Treatments: Other: Maternal Outcome Monitoring and Support system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06415942

5R00MD015781-04 (U.S. NIH Grant/Contract)

AAAU9647

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

MOMS intervention

Experimental group

Description:

Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.

Treatment:

Other: Maternal Outcome Monitoring and Support system