Clinical trial NCT05502510: Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Official title: Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Preterm Birth
Lead sponsor: Naima Health LLC
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2022-08-16
Enrollment: 12344
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria:

* Offered a prescription for MyHealthyPregnancy
* 18+ years of age
* Pregnant
* Seeking care at a UPMC hospital
* Delivered at a UPMC hospital

Primary outcomes:
measure: Gestational Age at Birth
timeFrame: Baseline to 40 Weeks
Secondary outcomes:
measure: Prenatal Births
timeFrame: Baseline to 37 Weeks
measure: Depression Rates
timeFrame: Baseline to 40 Weeks
measure: Anxiety Rates
timeFrame: Baseline to 40 Weeks
measure: Referrals to Behavioral Health Specialists
timeFrame: Baseline to 40 Weeks
measure: Referrals to Social Workers
timeFrame: Baseline to 40 Weeks
measure: Preeclampsia
timeFrame: Baseline to 40 Weeks
measure: Gestational Weight Gain
timeFrame: Baseline to 40 Weeks
measure: Attendance at Prenatal Appointments
timeFrame: Baseline to 40 Weeks
measure: Attendance at Required Prenatal Appointments
timeFrame: Baseline to 40 Weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References: