An interventional study of Maternal Outcome Monitoring and Support system in Maternal Death and Maternal Complication of Pregnancy, sponsored by Columbia University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's enrollment of 84 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
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
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).
Patient activation
Change in patient activation measured using the validated Patient Activation Measure (PAM)
Time frame: Baseline to 6 weeks postpartum
Knowledge of pregnancy related death warning signs
Change in knowledge of warning signs for pregnancy related death
Time frame: Baseline to 6 weeks postpartum
Plan to share: No — Data will be shared in the aggregate. There is no plan to make IDP available to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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