Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
1 other identifier
observational
12,344
1 country
1
Brief Summary
One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedAugust 16, 2022
August 1, 2022
2.4 years
August 12, 2022
August 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Gestational Age at Birth
Gestational age at birth will be measured using each patients electronic health record. The average treatment effect will be calculated using linear regression comparing MHP and usual care cohorts. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects gestational age at birth.
Baseline to 40 Weeks
Secondary Outcomes (9)
Prenatal Births
Baseline to 37 Weeks
Depression Rates
Baseline to 40 Weeks
Anxiety Rates
Baseline to 40 Weeks
Referrals to Behavioral Health Specialists
Baseline to 40 Weeks
Referrals to Social Workers
Baseline to 40 Weeks
- +4 more secondary outcomes
Study Arms (2)
MyHealthyPregnancy (MHP)
Use of the MyHealthyPregnancy application in conjunction with usual care.
Usual Prenatal Care (usual care)
Usual prenatal care consisting of biweekly visits with the patient care team.
Interventions
MyHealthyPregnancy is a mobile application prescribed to expectant mothers in conjunction with normal prenatal care. The application uses behavioral decision science principles to identify risks of preterm birth and alert the mother and care team of these risks.
Eligibility Criteria
Pregnant people offered a prescription for MyHealthyPregnancy who were at least 18 years of age, pregnant, received care at UPMC, and delivered at a UPMC hospital
You may qualify if:
- Offered a prescription for MyHealthyPregnancy
- + years of age
- Pregnant
- Seeking care at a UPMC hospital
- Delivered at a UPMC hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naima Health LLClead
- Carnegie Mellon Universitycollaborator
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 16, 2022
Study Start
September 23, 2019
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
August 16, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share