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Clinical Trials/NCT05502510
NCT05502510
Completed
Not Applicable

Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Naima Health LLC1 site in 1 country12,344 target enrollmentSeptember 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Naima Health LLC
Enrollment
12344
Locations
1
Primary Endpoint
Gestational Age at Birth
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 23, 2019
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gestational Age at Birth

Time Frame: 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 Outcomes

  • Referrals to Behavioral Health Specialists(Baseline to 40 Weeks)
  • Attendance at Required Prenatal Appointments(Baseline to 40 Weeks)
  • Prenatal Births(Baseline to 37 Weeks)
  • Attendance at Prenatal Appointments(Baseline to 40 Weeks)
  • Referrals to Social Workers(Baseline to 40 Weeks)
  • Gestational Weight Gain(Baseline to 40 Weeks)
  • Depression Rates(Baseline to 40 Weeks)
  • Anxiety Rates(Baseline to 40 Weeks)
  • Preeclampsia(Baseline to 40 Weeks)

Study Sites (1)

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