Improving maternal health monitoring for pregnant women
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
This study is testing a new mobile health system to help pregnant women, especially those from minority groups, recognize warning signs of complications and get the care they need to improve their health during and after pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06415942 on ClinicalTrials.gov |
What this trial studies
This project aims to address the rising rates of pregnancy-related deaths, particularly among minority groups such as African-American and Spanish-speaking Latina women. By developing a mobile health (mHealth) system, the study seeks to enhance patients' ability to recognize warning signs of complications and encourage timely medical care. The intervention focuses on empowering mothers through self-monitoring and decision support, ultimately improving their knowledge and activation regarding maternal health. The pilot trial will assess the feasibility and preliminary effectiveness of this approach among postpartum patients.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 28 weeks, aged 18 or older, who identify as Black or African American or Hispanic/Latino and are receiving healthcare in the United States.
Not a fit: Patients with severe cognitive impairment, major psychiatric illness, or terminal illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce preventable maternal deaths by improving awareness and timely medical intervention among at-risk populations.
How similar studies have performed: Other studies have shown promise in using mobile health interventions to improve maternal health outcomes, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 1 other locations
- NewYork-Presbyterian Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- NewYork-Prebyterian/Weill Cornell Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Natalie Benda
- Email: nb3115@cumc.columbia.edu
- Phone: 917-426-3069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.