Assessing the Maternal Outcome Monitoring Systems

Not Applicable

Recruiting

• Conditions: Maternal Death; Maternal Complication of Pregnancy
• Interventions: Other: Maternal Outcome Monitoring and Support system

• Registration Number: NCT06415942
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-16
• Status Verified: 2024-12
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOMS intervention	Maternal Outcome Monitoring and Support system	Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.

Primary Outcome Measures

Name	Time	Method
Patient activation	Baseline to 6 weeks postpartum	Change in patient activation measured using the validated Patient Activation Measure (PAM)

Secondary Outcome Measures

Name	Time	Method
Knowledge of pregnancy related death warning signs	Baseline to 6 weeks postpartum	Change in knowledge of warning signs for pregnancy related death

Trial Locations

Locations (2)

NewYork-Presbyterian Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

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