Pregnancy
Conditions
Brief 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. 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: 1. the number of in-person OB visits during pregnancy; 2. patient satisfaction with prenatal care; 3. gestational weight gain; 4. maternal and fetal outcomes; and 5. 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.
Interventions
DEVICEBabyscripts Prenatal App
The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
DEVICEPlacebo
No Mobile App, Usual care
Sponsors
1EQ, Inc.
Andrew Meltzer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* High-risk obstetrical condition\* * Intends midwifery care * Intends to terminate * Not Local resident * Non--English speaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Visit Number | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | From first trimester up to postpartum, between 6 and 9 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Babyscripts Prenatal App For patients allocated to the study 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 who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and 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.
Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care. | 47 |
| Placebo For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent 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.
Placebo: No Mobile App, Usual care | 41 |
| Total | 88 |
Baseline characteristics
| Characteristic | Babyscripts Prenatal App | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.0 years STANDARD_DEVIATION 3.3 | 32.2 years STANDARD_DEVIATION 3.2 | 32.6 years STANDARD_DEVIATION 3 |
| College Graduate | 45 Participants | 36 Participants | 81 Participants |
| Gravidity Per Patient Greater than One | 22 Participants | 19 Participants | 41 Participants |
| Gravidity Per Patient One | 25 Participants | 22 Participants | 47 Participants |
| Parity Per Patient Greater than One | 17 Participants | 16 Participants | 33 Participants |
| Parity Per Patient Zero | 30 Participants | 25 Participants | 55 Participants |
| Race/Ethnicity, Customized African-American | 14 Participants | 13 Participants | 27 Participants |
| Race/Ethnicity, Customized Other | 33 Participants | 28 Participants | 61 Participants |
| Region of Enrollment United States | 47 participants | 41 participants | 88 participants |
| Sex: Female, Male Female | 47 Participants | 41 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 51 |
| other Total, other adverse events | 0 / 45 | 0 / 51 |
| serious Total, serious adverse events | 0 / 45 | 0 / 51 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Babyscripts Prenatal App | Total Visit Number | 7.9 visits | Standard Deviation 1.8 |
| Placebo | Total Visit Number | 10.2 visits | Standard Deviation 1.8 |
p-value: <0.001t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Babyscripts Prenatal App | Gestational Weight Gain | Overweight (25<BMI<30) | 35.0 pounds | Standard Deviation 10.8 |
| Babyscripts Prenatal App | Gestational Weight Gain | Obese (BMI>30) | 13.0 pounds | Standard Deviation 0 |
| Babyscripts Prenatal App | Gestational Weight Gain | Underweight (BMI< 18.5) | 22.9 pounds | Standard Deviation 13.4 |
| Babyscripts Prenatal App | Gestational Weight Gain | Normal (18.5<BMI<25) | 34.0 pounds | Standard Deviation 8.4 |
| Placebo | Gestational Weight Gain | Normal (18.5<BMI<25) | 30.5 pounds | Standard Deviation 7.7 |
| Placebo | Gestational Weight Gain | Overweight (25<BMI<30) | 24.2 pounds | Standard Deviation 11.2 |
| Placebo | Gestational Weight Gain | Underweight (BMI< 18.5) | 20.9 pounds | Standard Deviation 4.8 |
| Placebo | Gestational Weight Gain | Obese (BMI>30) | 9.4 pounds | Standard Deviation 9.6 |