Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome
Conditions
Brief summary
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.
Detailed description
While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.
Interventions
See arm description
Sponsors
Medical University of South Carolina
South Carolina Telehealth Alliance
Babyscripts
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution. * Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.
Exclusion criteria
* \<18 years of age * BMI \>50 (due to limitations in blood pressure cuff size through BabyScripts) * non English-speaking * not able to receive phone calls and unlimited texts on cell phone * not able to download and use Babyscripts phone application
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum | 10 days | How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Antihypertensive After Discharge | 16 days | How many participants required initiation of antihypertensive after discharge |
| Unscheduled Visits | 16 days | Number of participants with unscheduled visits |
| Readmission | 6 weeks | Number of participants readmitted postpartum |
| Attended Postpartum Visit | 6 weeks | Number of participants who attended their postpartum visit |
Countries
United States
Participant flow
Recruitment details
The recruitment was conducted at Prisma Health (Greenville, SC, USA) and the Medical University of South Carolina (Charleston, SC, USA) between April 2021 and September 2021. The recruitment took place inpatient at the obstetric units of both hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum | 101 |
| Intervention Patient will receive a Babyscripts blood pressure cuff(brand: A&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description | 96 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Standard Care | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years | 28.9 years | 29.1 years |
| BMI | 34.0 kg/m^2 | 32.9 kg/m^2 | 33.3 kg/m^2 |
| Chronic Hypertension | 26 Participants | 17 Participants | 43 Participants |
| Diabetes Gestational diabetes | 10 Participants | 20 Participants | 30 Participants |
| Diabetes Type 1 Diabetes | 2 Participants | 1 Participants | 3 Participants |
| Diabetes Type 2 Diabetes | 2 Participants | 5 Participants | 7 Participants |
| Gestational Age at Delivery | 37.3 Weeks | 37.5 Weeks | 37.3 Weeks |
| Hypertensive Disease Severity Eclampsia | 1 Participants | 2 Participants | 3 Participants |
| Hypertensive Disease Severity Gestational hypertension | 37 Participants | 42 Participants | 79 Participants |
| Hypertensive Disease Severity HELLP syndrome | 0 Participants | 2 Participants | 2 Participants |
| Hypertensive Disease Severity Preeclampsia without severe features | 15 Participants | 7 Participants | 22 Participants |
| Hypertensive Disease Severity Preeclampsia with severe features | 48 Participants | 43 Participants | 91 Participants |
| Insurance Medicaid | 58 Participants | 59 Participants | 117 Participants |
| Insurance None | 4 Participants | 1 Participants | 5 Participants |
| Insurance Private | 39 Participants | 36 Participants | 75 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 34 Participants | 28 Participants | 62 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 11 Participants | 15 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 59 Participants | 56 Participants | 115 Participants |
| Region of Enrollment United States | 101 participants | 96 participants | 197 participants |
| Renal Disease | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 101 Participants | 96 Participants | 197 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Timing of Diagnosis Antepartum | 70 Participants | 57 Participants | 127 Participants |
| Timing of Diagnosis Intrapartum | 25 Participants | 29 Participants | 54 Participants |
| Timing of Diagnosis Postpartum | 6 Participants | 10 Participants | 16 Participants |
| Tobacco use Current | 13 Participants | 12 Participants | 25 Participants |
| Tobacco use Former | 28 Participants | 16 Participants | 44 Participants |
| Tobacco use None | 59 Participants | 68 Participants | 127 Participants |
| Tobacco use Unknown | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 101 |
| other Total, other adverse events | 0 / 101 | 0 / 96 |
| serious Total, serious adverse events | 0 / 101 | 0 / 101 |
Outcome results
Primary
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum | 59 Participants |
| Intervention | Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum | 89 Participants |
p-value: <0.00195% CI: [1.33, 1.88]Chi-squared
Secondary
Attended Postpartum Visit
Number of participants who attended their postpartum visit
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Attended Postpartum Visit | 71 Participants |
| Intervention | Attended Postpartum Visit | 75 Participants |
p-value: 0.2195% CI: [0.94, 1.31]Chi-squared
Secondary
Initiation of Antihypertensive After Discharge
How many participants required initiation of antihypertensive after discharge
Time frame: 16 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Initiation of Antihypertensive After Discharge | 7 Participants |
| Intervention | Initiation of Antihypertensive After Discharge | 9 Participants |
p-value: 0.5395% CI: [0.52, 3.49]Fisher Exact
Secondary
Readmission
Number of participants readmitted postpartum
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Readmission | 5 Participants |
| Intervention | Readmission | 4 Participants |
p-value: 0.79295% CI: [0.23, 3.04]Fisher Exact
Secondary
Unscheduled Visits
Number of participants with unscheduled visits
Time frame: 16 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Unscheduled Visits | 5 Participants |
| Intervention | Unscheduled Visits | 12 Participants |
p-value: 0.05995% CI: [0.92, 6.9]Fisher Exact