Skip to main content
OpenTrials
Completed

NCT Number: NCT05502510

Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Related Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

MyHealthyPregnancy

Behavioral

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.

Primary outcomes

  1. 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

  1. Prenatal Births

    Time frame: 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.

  2. Depression Rates

    Time frame: 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.

  3. Anxiety Rates

    Time frame: 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.

  4. Referrals to Behavioral Health Specialists

    Time frame: 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.

  5. Referrals to Social Workers

    Time frame: 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.

  6. Preeclampsia

    Time frame: 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.

  7. Gestational Weight Gain

    Time frame: 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.

  8. Attendance at Prenatal Appointments

    Time frame: 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.

  9. Attendance at Required Prenatal Appointments

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Naima Health LLC

Other

Collaborators

  • Carnegie Mellon University

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.