Assessing the Maternal Outcome Monitoring Systems | NCT06415942

Studies
Assessing the Maternal Outcome Monitoring Systems

NCT06415942

Sponsor

Columbia University

Status

Completed

Last Update Posted

Jul 10, 2026Actual

Enrollment

84Actual

Phase

Not Applicable

Conditions

Maternal Death
Maternal Complication of Pregnancy

Interventions

Maternal Outcome Monitoring and Support system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R00MD015781-04	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2024Actual

Primary Completion Date

Apr 28, 2026Actual

Completion Date

Jun 10, 2026Actual

First Submitted Date

May 13, 2024

First Submission Date that Met QC Criteria

May 13, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Name	Class
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Knowledge of pregnancy related death warning signs	Change in knowledge of warning signs for pregnancy related death	Baseline to 6 weeks postpartum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NewYork-Presbyterian Columbia University Irving Medical Center		New York	New York	10032	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be shared in the aggregate. There is no plan to make IDP available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063130	Maternal Death
D010358	Patient Participation

Ancestor Terms

ID	Term
D063129	Parental Death
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided