PregnancySPROUTNCT02914301
Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study
A study testing Babyscripts Prenatal App in people with Pregnancy, run by Andrew Meltzer at 1 site in United States.
Trial summary
Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Babyscripts Prenatal App
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
- Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.
Who cannot join
- High-risk obstetrical condition*
- Intends midwifery care
- Intends to terminate
- Not Local resident
- Non--English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Effectiveness of a Mobile App for Prenatal Care to Safely Reduce In-Person Visits and Improve Patient Satisfaction: Study Protocol for a Multicenter Prospective Quasi-Randomized Trial
Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.
Read the detailed description
This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:
- the number of in-person OB visits during pregnancy;
- patient satisfaction with prenatal care;
- gestational weight gain;
- maternal and fetal outcomes; and
- clinician satisfaction.
To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.
- Conditions
- Pregnancy
- Being tested
- Babyscripts Prenatal App, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babyscripts Prenatal AppDevice
The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
PlaceboDevice
No Mobile App, Usual care
| Study group | Role | What they receive |
|---|---|---|
| Babyscripts Prenatal App | Active comparator | For patients allocated to the experimental group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. Receives: Device: Babyscripts Prenatal App |
| Placebo | Placebo comparator | For patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Visit Number
In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.
Measured: From first trimester up to postpartum, between 6 and 9 months
Secondary outcomes (1)
Gestational Weight Gain
We will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability.
Measured: From first trimester up to postpartum, between 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Meltzer
- Sponsor type
- University, hospital or other
- Collaborators
- 1EQ, Inc.
- Responsible party
- Sponsor-investigator, Andrew Meltzer, George Washington University
- Investigators
- Andrew C Meltzer, MD, MS, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914301
- Sponsor's protocol ID
- BABYSCRIPTS 1B
- Acronym
- SPROUT
- Status last verified
- Nov 2022
- First submitted
- 8 Sep 2016
- Last updated
- 16 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520.
PubMed 31042154
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile App for Prenatal Care to Safely Reduce In-Person Visits and Improve Patient Satisfaction: Study Protocol for a Multicenter Prospective Quasi-Randomized Trial
- ClinicalTrials.gov ID
- NCT02914301
- Acronym / sponsor ID
- SPROUT / BABYSCRIPTS 1B
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Andrew MeltzerUniversity, hospital or other
- Collaborators
- 1EQ, Inc.
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 16 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.
Detailed description
This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:
- the number of in-person OB visits during pregnancy;
- patient satisfaction with prenatal care;
- gestational weight gain;
- maternal and fetal outcomes; and
- clinician satisfaction.
To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babyscripts Prenatal App | Active comparator | Device: Babyscripts Prenatal AppFor patients allocated to the experimental group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. |
| Placebo | Placebo comparator | Device: PlaceboFor patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
- Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.
Key exclusion criteria (5 listed)
- High-risk obstetrical condition*
- Intends midwifery care
- Intends to terminate
- Not Local resident
- Non--English speaker
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 |
|---|---|---|
| Babyscripts Prenatal AppThe use of a mobile digital app to facilitate certain aspects of standard prenatal care. | Device | Babyscripts Prenatal App |
| PlaceboNo Mobile App, Usual care | Device | Placebo |
Primary outcome
Total Visit Number
Time frame: From first trimester up to postpartum, between 6 and 9 months
In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.
1 secondary outcome
Gestational Weight Gain
Time frame: From first trimester up to postpartum, between 6 and 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31042154Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520.
- site for mobile appLink provided by the sponsor.
- 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.
Andrew C Meltzer, MD, MS principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Babyscripts Prenatal App in people with Pregnancy, run by Andrew Meltzer 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 2 inclusion and 5 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 Dec 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Visit Number (time frame: From first trimester up to postpartum, between 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914301, which also lists 1 linked publication.
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 Dec 2022.