Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

NCT ID: NCT05502510

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-23

Study Completion Date

2022-02-28

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MyHealthyPregnancy (MHP)

Use of the MyHealthyPregnancy application in conjunction with usual care.

MyHealthyPregnancy

Intervention Type 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.

Usual Prenatal Care (usual care)

Usual prenatal care consisting of biweekly visits with the patient care team.

No interventions assigned to this group

Interventions

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MyHealthyPregnancy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Carnegie Mellon University

OTHER

Sponsor Role collaborator

Naima Health LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Analytic Code

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View Document

Other Identifiers

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1684

Identifier Type: -

Identifier Source: org_study_id

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