Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| South Carolina Telehealth Alliance | OTHER |
| Babyscripts | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum | |
| Intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home blood pressure monitoring | Device | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of Antihypertensive After Discharge | How many participants required initiation of antihypertensive after discharge | 16 days |
| Unscheduled Visits | Number of participants with unscheduled visits |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Renata Sawyer, MD | Prisma Health-Upstate | Principal Investigator |
| David Soper, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States | ||
| Greenville Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37734091 | Derived | Arkerson BJ, Finneran MM, Harris SR, Schnorr J, McElwee ER, Demosthenes L, Sawyer R. Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial. Obstet Gynecol. 2023 Oct 1;142(4):855-861. doi: 10.1097/AOG.0000000000005327. Epub 2023 Sep 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 10 days |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Finneran | The Medical University of South Carolina | (843) 792-4500 | finneram@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2021 | Jan 25, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2021 | Jan 11, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2021 | Apr 24, 2023 | ICF_004.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D017359 | HELLP Syndrome |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
Not provided
Not provided
| ID | Term |
|---|---|
| D018660 | Blood Pressure Monitoring, Ambulatory |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| 16 days |
| Readmission | Number of participants readmitted postpartum | 6 weeks |
| Attended Postpartum Visit | Number of participants who attended their postpartum visit | 6 weeks |
| Greenville |
| South Carolina |
| 29605 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Tobacco use | Count of Participants | Participants |
|
| Chronic Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Renal Disease | Count of Participants | Participants |
|
| Timing of Diagnosis | Count of Participants | Participants |
|
| Gestational Age at Delivery | Median | Inter-Quartile Range | Weeks |
|
| Hypertensive Disease Severity | Count of Participants | Participants |
|
|
|
|
| Secondary | Initiation of Antihypertensive After Discharge | How many participants required initiation of antihypertensive after discharge | Posted | Count of Participants | Participants | 16 days |
|
|
|
|
| Secondary | Unscheduled Visits | Number of participants with unscheduled visits | Posted | Count of Participants | Participants | 16 days |
|
|
|
|
| Secondary | Readmission | Number of participants readmitted postpartum | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| Secondary | Attended Postpartum Visit | Number of participants who attended their postpartum visit | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | 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 | 0 | 101 | 0 | 101 | 0 | 96 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |