Assessing the Maternal Outcome Monitoring Systems

NCT06415942 | Recruiting

• 2 other identifiers: AAAU96475R00MD015781-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Maternal Death; Maternal Complication of Pregnancy

Keywords

pregnancy related death; patient reported outcomes; mHealth; patient activation

Outcome Measures

Primary Outcomes (1)

• Patient activation

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

  Baseline to 6 weeks postpartum

Secondary Outcomes (1)

• Knowledge of pregnancy related death warning signs

  Baseline to 6 weeks postpartum

Study Arms (1)

MOMS intervention

EXPERIMENTAL

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

Other: Maternal Outcome Monitoring and Support system

Interventions

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).

MOMS intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

NewYork-Presbyterian Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

NewYork-Prebyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Maternal Death; Patient Participation

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Natalie Benda

CONTACT

917-426-3069; nb3115@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: December 11, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)