Pregnancy Related, Preterm Birth
Conditions
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.
Detailed description
MyHealthyPregnancy (MHP) is an application that was developed using behavioral decision science principles. This study seeks to evaluate the effectiveness and efficacy of the application. MyHealthyPregnancy was offered to expectant mothers at the University of Pittsburgh Medical Center in conjunction with usual prenatal care. The primary objective is to compare the reduction in gestational age at birth between MHP and usual care cohorts. Secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the MHP and usual care cohorts.
Interventions
BEHAVIORALMyHealthyPregnancy
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.
Sponsors
Carnegie Mellon University
Naima Health LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Offered a prescription for MyHealthyPregnancy * 18+ years of age * Pregnant * Seeking care at a UPMC hospital * Delivered at a UPMC hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Age at Birth | Baseline to 40 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Rates | Baseline to 40 Weeks | Depression rates will be measured using diagnoses of depression in each patient's electronic health record. Depression rates between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects depression rates. |
| Anxiety Rates | Baseline to 40 Weeks | Anxiety rates will be measured using diagnoses of anxiety in each patient's electronic health record. Anxiety rates between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects anxiety rates. |
| Referrals to Behavioral Health Specialists | Baseline to 40 Weeks | Rates of referrals to behavioral health specialists will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals. |
| Referrals to Social Workers | Baseline to 40 Weeks | Rates of referrals to social workers will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals. |
| Prenatal Births | Baseline to 37 Weeks | Occurrence of preterm birth will be measured using each patient's electronic health record. The likelihood of preterm birth between the MHP and usual care cohorts will be compared using logistic regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preterm birth. |
| Gestational Weight Gain | Baseline to 40 Weeks | Gestational weight gain will be measured by calculating the difference between each patient's initial weight and delivery weight recorded in their electronic health record. Gestational weight gain will be categorized as sufficient or insufficient according to 2009 Institute of Medicine guidelines. The likelihood of achieving sufficient gestational weight gain between the MHP and usual care cohorts will be compared using ordinal regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects the likelihood of achieving sufficient gestational weight gain. |
| Attendance at Prenatal Appointments | Baseline to 40 Weeks | Number of prenatal visits attended will be measured using each patient's electronic health record. The number of visits attended between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits. |
| Attendance at Required Prenatal Appointments | Baseline to 40 Weeks | The percent of required prenatal appointments attended will be measured using each patient's electronic health record. The percent of visits attended between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits. |
| Preeclampsia | Baseline to 40 Weeks | Preeclampsia will be measured using each patient's electronic health record. Rates of preeclampsia between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preeclampsia. |
Countries
United States
Outcome results
None listed