Assessing the Maternal Outcome Monitoring Systems

Maternal Death Clinical Trial

— MOMS  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415942
• Other study ID #: AAAU9647
• Secondary ID: 5R00MD015781-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Natalie Benda
• Phone: 917-426-3069
• Email: nb3115[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Complication of Pregnancy
• Maternal Death
• Pregnancy Complications

Intervention

Other:
• Maternal Outcome Monitoring and Support system
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).

Locations

Country	Name	City	State
United States	NewYork-Prebyterian/Weill Cornell Medical Center	New York	New York
United States	NewYork-Presbyterian Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient activation	Change in patient activation measured using the validated Patient Activation Measure (PAM)	Baseline to 6 weeks postpartum
Secondary	Knowledge of pregnancy related death warning signs	Change in knowledge of warning signs for pregnancy related death	Baseline to 6 weeks postpartum