Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06415942

Single Arm Clinical Trial of a Smartphone-Based Symptom Monitoring and Decision Support Tool for African American and Spanish-Speaking Patients in the Near Postpartum Period

Led by Columbia University · Updated on 2026-06-01

80

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pregnancy-related death rates have significantly increased in the United States over the past two decades, with many cases considered preventable. This research focuses on improving awareness and decision-making among postpartum patients, especially African American and Spanish-speaking Latina women, to help them recognize warning signs and seek timely medical care. The study evaluates a mobile health approach designed to support these patients in self-monitoring symptoms and receiving guidance on when to seek help. Participants will use the Maternal Outcome Monitoring and Support (MOMS) system, a smartphone application that allows them to report symptoms related to pregnancy complications. The app provides decision support to help users decide when to contact their healthcare provider or visit an emergency room. This single-arm pilot trial assesses the feasibility and early impact of this intervention in improving patient knowledge and activation during the postpartum period. During the study, participants will engage with the MOMS app from baseline through six weeks postpartum, with researchers measuring changes in patient activation and knowledge of pregnancy-related death warning signs. The study will monitor participants remotely through the app, collecting patient-reported outcomes to evaluate how well the system supports timely care-seeking behavior. This involvement aims to improve postpartum health outcomes in diverse populations facing disparities.

CONDITIONS

Brief Title

Assessing the Maternal Outcome Monitoring Systems

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 able to speak and read Spanish AND preferred language of Spanish
  • Planned delivery at NewYork-Presbyterian hospitals including Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, or Lower Manhattan Hospital
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 6 weeks postpartum

Participants use the Maternal Outcome Monitoring and Support system, a mobile health app that helps them monitor symptoms and provides decision support on when to seek medical care during the postpartum period.

1 baseline visit and weekly follow-up visits for up to 6 weeks

Trial Site Locations

Total: 2 locations

1

NewYork-Presbyterian Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

2

NewYork-Prebyterian/Weill Cornell Medical Center

New York, New York, United States, 10065

Actively Recruiting

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Research Team

N

Natalie Benda

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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