Trial Outcomes & Findings for Remote Surveillance of Postpartum Hypertension (NCT NCT03185455)
NCT ID: NCT03185455
Last Updated: 2023-04-12
Results Overview
the percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
10 days postdischarge
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Standard of Care
Women randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. The date and time of the office appointment is specified in the discharge document and reviewed with the patient prior to discharge. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
Women randomized to the text-based surveillance arm will be given an automatic Omron© blood pressure cuff and instructed on use by research team members prior to discharge. Patients will be enrolled into the texting program platform developed through Way to Health. A starting introductory text message is sent by the Way to Health platform to the phone number provided on day of discharge. Patients receive reminders to text message their blood pressures twice daily for two weeks postpartum, starting on the day after discharge. Immediate feedback is provided to the patient based on a preprogrammed automated algorithm. The primary investigator is alerted with pre-specified severe range blood pressure values (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHg) via text message or email and care is escalated as needed based on the same outpatient algorithm used in the office.
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
103
|
|
Overall Study
COMPLETED
|
103
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote Surveillance of Postpartum Hypertension
Baseline characteristics by cohort
| Measure |
Standard of Care
n=103 Participants
Women randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. The date and time of the office appointment is specified in the discharge document and reviewed with the patient prior to discharge. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=103 Participants
Women randomized to the text-based surveillance arm will be given an automatic Omron© blood pressure cuff and instructed on use by research team members prior to discharge. Patients will be enrolled into the texting program platform developed through Way to Health. A starting introductory text message is sent by the Way to Health platform to the phone number provided on day of discharge. Patients receive reminders to text message their blood pressures twice daily for two weeks postpartum, starting on the day after discharge. Immediate feedback is provided to the patient based on a preprogrammed automated algorithm. The primary investigator is alerted with pre-specified severe range blood pressure values (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHg) via text message or email and care is escalated as needed based on the same outpatient algorithm used in the office.
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 5 • n=5 Participants
|
28 years
STANDARD_DEVIATION 6 • n=7 Participants
|
28 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
103 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Medicaid Insurance
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Body Mass Index
|
31 kg/m^2
n=5 Participants
|
30.1 kg/m^2
n=7 Participants
|
30.2 kg/m^2
n=5 Participants
|
|
Nulliparous
|
52 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Pregestational diabetes
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Gestational diabetes
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Chronic hypertension without antihypertensive medication
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Chronic hypertension with antihypertensive medication
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Renal disease
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Gestational age at diagnosis
|
38 weeks
n=5 Participants
|
38 weeks
n=7 Participants
|
38 weeks
n=5 Participants
|
|
Gestational age at delivery
|
38 weeks
n=5 Participants
|
38 weeks
n=7 Participants
|
38 weeks
n=5 Participants
|
|
Gestational hypertension/preeclampsia without severe features
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Preeclampsia with severe features
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Hemolysis Elevated Liver Enzymes Low Platelet syndrome
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Superimposed preeclampsia
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Eclampsia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Induction of labor
|
58 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Cesarean delivery in labor
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Planned cesarean delivery
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Magnesium sulfate use
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Live birth
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Discharged on oral antihypertensive medication
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Postpartum discharge day
|
2 day
n=5 Participants
|
2 day
n=7 Participants
|
2 day
n=5 Participants
|
|
Breastfeeding
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 days postdischargethe percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.
Outcome measures
| Measure |
Standard of Care
n=103 Participants
Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=103 Participants
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
|
|---|---|---|
|
Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge
|
45 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Only women who attended the office visit were analyzed in the standard of care group
Number of participants who required antihypertensive medication initiation or dose adjustment within 2 weeks postpartum
Outcome measures
| Measure |
Standard of Care
n=45 Participants
Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=103 Participants
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
|
|---|---|---|
|
Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumNumber of participants who required additional ER or office visits for hypertension (not resulting in readmission) within 2 weeks postpartum
Outcome measures
| Measure |
Standard of Care
n=103 Participants
Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=103 Participants
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
|
|---|---|---|
|
Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumNumber of participants with hypertension related readmission within 2 weeks postpartum
Outcome measures
| Measure |
Standard of Care
n=103 Participants
Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=103 Participants
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
|
|---|---|---|
|
Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: The data population analyzed in the Remote Surveillance Arm included only those who completed the satisfaction survey. Participants in the standard of care arm were not eligible to complete the Patient Satisfaction Survey since they did not receive the intervention.
Patient who would recommend the program to a family or friend as per the Patient Satisfaction Survey completed at 2 weeks postpartum.
Outcome measures
| Measure |
Standard of Care
Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
|
Remote (Text Based) Surveillance
n=77 Participants
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
|
|---|---|---|
|
Patient Satisfaction
|
0 Participants
|
77 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remote (Text Based) Surveillance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place