Pregnancy RelatedNCT05502510
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
An observational study of Pregnancy Related and Preterm Birth, run by Naima Health LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Preterm Birth
- What is being tested?
- MyHealthyPregnancy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12,344 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Offered a prescription for MyHealthyPregnancy
- 18+ years of age
- Pregnant
- Seeking care at a UPMC hospital
- Delivered at a UPMC hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related, Preterm Birth
- Being tested
- MyHealthyPregnancy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHealthyPregnancyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MyHealthyPregnancy (MHP) | Use of the MyHealthyPregnancy application in conjunction with usual care. Receives: Behavioral: MyHealthyPregnancy | |
| Usual Prenatal Care (usual care) | Usual prenatal care consisting of biweekly visits with the patient care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Age at Birth
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.
Measured: Baseline to 40 Weeks
Secondary outcomes (9)
Prenatal Births
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.
Measured: Baseline to 37 Weeks
Depression Rates
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.
Measured: Baseline to 40 Weeks
Anxiety Rates
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.
Measured: Baseline to 40 Weeks
Referrals to Behavioral Health Specialists
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.
Measured: Baseline to 40 Weeks
Referrals to Social Workers
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.
Measured: Baseline to 40 Weeks
Preeclampsia
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.
Measured: Baseline to 40 Weeks
Gestational Weight Gain
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.
Measured: Baseline to 40 Weeks
Attendance at Prenatal Appointments
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.
Measured: Baseline to 40 Weeks
Attendance at Required Prenatal Appointments
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.
Measured: Baseline to 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start23 Sep 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naima Health LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502510
- Sponsor's protocol ID
- 1684
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
- ClinicalTrials.gov ID
- NCT05502510
- Acronym / sponsor ID
- 1684
- Conditions
- Pregnancy Related, Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,344 participants (actual)
- Lead sponsor
- Naima Health LLCUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyHealthyPregnancy (MHP) | – | Behavioral: MyHealthyPregnancyUse of the MyHealthyPregnancy application in conjunction with usual care. |
| Usual Prenatal Care (usual care) | – | –Usual prenatal care consisting of biweekly visits with the patient care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Offered a prescription for MyHealthyPregnancy
- 18+ years of age
- Pregnant
- Seeking care at a UPMC hospital
- Delivered at a UPMC hospital
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyHealthyPregnancyMyHealthyPregnancy 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. | Behavioural | MyHealthyPregnancy (MHP) |
Primary outcome
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.
9 secondary outcomes
Prenatal Births
Time frame: Baseline to 37 Weeks
Depression Rates
Time frame: Baseline to 40 Weeks
Anxiety Rates
Time frame: Baseline to 40 Weeks
Referrals to Behavioral Health Specialists
Time frame: Baseline to 40 Weeks
Referrals to Social Workers
Time frame: Baseline to 40 Weeks
Preeclampsia
Time frame: Baseline to 40 Weeks
Gestational Weight Gain
Time frame: Baseline to 40 Weeks
Attendance at Prenatal Appointments
Time frame: Baseline to 40 Weeks
Attendance at Required Prenatal Appointments
Time frame: Baseline to 40 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Preterm Birth, run by Naima Health LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Age at Birth (time frame: Baseline to 40 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.