An interventional study of Babyscripts Prenatal App and Placebo in Pregnancy, sponsored by Andrew Meltzer. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Andrew Meltzer · Not applicable, Interventional, and Prevention
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.
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:
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.
Andrew Meltzer is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Babyscripts Prenatal App
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.
Device: Placebo
The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
No Mobile App, Usual care
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.
Time frame: From first trimester up to postpartum, between 6 and 9 months
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.
Time frame: From first trimester up to postpartum, between 6 and 9 months
| Milestone | Babyscripts Prenatal App | Placebo |
|---|---|---|
| Started | 60 | 58 |
| Completed | 47 | 41 |
| Not completed | 13 | 17 |
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.
| visits | Babyscripts Prenatal App | Placebo |
|---|---|---|
| Total Visit Number | 7.9 ± 1.8 | 10.2 ± 1.8 |
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.
| pounds | Babyscripts Prenatal App | Placebo |
|---|---|---|
| Underweight (BMI< 18.5) | 22.9 ± 13.4 | 20.9 ± 4.8 |
| Normal (18.5<BMI<25) | 34.0 ± 8.4 | 30.5 ± 7.7 |
| Overweight (25<BMI<30) | 35.0 ± 10.8 | 24.2 ± 11.2 |
| Obese (BMI>30) | 13.0 ± 0 | 9.4 ± 9.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Babyscripts Prenatal App | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Placebo | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| Mean | 33.0 ± 3.3 | 32.2 ± 3.2 | 32.6 ± 3 |
| Sex: Female, Male(Participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| Female | 47 | 41 | 88 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| African-American | 14 | 13 | 27 |
| Other | 33 | 28 | 61 |
| Region of Enrollment(participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| United States | 47 | 41 | 88 |
| College Graduate(Participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| Count of participants | 45 | 36 | 81 |
| Gravidity Per Patient(Participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| One | 25 | 22 | 47 |
| Greater than One | 22 | 19 | 41 |
| Parity Per Patient(Participants) | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| Zero | 30 | 25 | 55 |
| Greater than One | 17 | 16 | 33 |
Plan to share: No
The record gives a start of Jul 2015, a primary completion of Mar 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2022, 6 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Andrew Meltzer