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Assessing the Maternal Outcome Monitoring Systems

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06415942
Acronym
MOMS
Enrollment
84
Registered
2024-05-16
Start date
2024-12-11
Completion date
2026-06-10
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Complication of Pregnancy, Maternal Death

Keywords

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

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.

Interventions

OTHERMaternal 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).

Sponsors

Columbia University
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient activationBaseline to 6 weeks postpartumChange in patient activation measured using the validated Patient Activation Measure (PAM)

Secondary

MeasureTime frameDescription
Knowledge of pregnancy related death warning signsBaseline to 6 weeks postpartumChange in knowledge of warning signs for pregnancy related death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026