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Remote BP Monitoring in the PP Period

A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03728790
Enrollment
213
Registered
2018-11-02
Start date
2018-11-09
Completion date
2020-05-11
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disorder of Pregnancy

Keywords

hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP

Brief summary

The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.

Detailed description

Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.

Interventions

Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Sponsors

Philips Healthcare
CollaboratorINDUSTRY
New York Presbyterian Hospital
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Randomized Control Trial with 2 arms

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Postpartum women * Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart) * At least 18 years of age * English or Spanish speakers

Exclusion criteria

* Non-English or Spanish speakers * Women who are not planning on obtaining their postpartum follow up at CUIMC * Women who are physically unable to hold or use the tablet * Women who do not have a working phone * Provider unwilling or unable to set up escalation pathway * Women who reside outside of New York State * Hypertension diagnosed postpartum

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure (BP) Surveillance AdherenceUp to 14 days from delivery hospitalization dischargePercentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment

Secondary

MeasureTime frameDescription
Number of Participants With Outpatient BP Assessment Within 14 DaysUp to 14 days from delivery hospitalization dischargeNumber of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home)
Percentage of Participants With Elevated BP After DischargeUp to 14 days from delivery hospitalization dischargeIncidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at outpatient blood pressure assessment
Number of Participants With Outpatient PP AssessmentUp to 8 weeks from deliveryNumber of participants who had an outpatient postpartum (PP) assessment
Percentage of Participants With Elevated Blood Pressure at the Postpartum VisitUp to 8 weeks from deliveryIncidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at the postpartum visit
Time to Medication InitiationUp to 8 weeks from deliveryTime to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
Number of Participants Initiated on Antihypertensive Therapy After Hospital DischargeUp to 8 weeks from deliveryNumber of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Total Percentage of Elevated Blood Pressure ReadingsUp to 14 days from delivery hospitalization dischargeOf all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as \>/=140 systolic or \>/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first).
Number of Participants With ED VisitUp to 8 weeks from deliveryNumber of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Number of Participants Who Developed Preeclampsia-associated ComplicationsUp to 8 weeks from deliveryNumber of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.
Number of Participants Referred to Primary Care for Continued Blood Pressure ManagementUp to 8 weeks from deliveryNumber of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit
Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)Up to 8 weeks from deliveryThe modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
Score on the Philips Program Start Survey and the Philips Program End SurveyBaseline, program end (up to 8 weeks from delivery)The Philips program start survey is a 4-question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6-question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The number reported is the average score for each group.
CommunicationsUp to 14 days post delivery hospitalization dischargeNumber of communications between patient and obstetric provider
Number of Participants ReadmittedUp to 8 weeks from deliveryNumber of participants who were readmitted after delivery hospitalization discharge

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from the inpatient postpartum service after delivery. Recruitment began on November 9, 2018. The last participant was recruited on July 10, 2019.

Participants by arm

ArmCount
Usual Care
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
112
Remote Patient Monitoring
Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit. Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
101
Total213

Baseline characteristics

CharacteristicTotalUsual CareRemote Patient Monitoring
Age, Continuous33 years32 years33 years
Born outside of United States103 Participants54 Participants49 Participants
Diabetes diagnosis
Gestational diabetes, diet controlled
13 Participants5 Participants8 Participants
Diabetes diagnosis
Gestational diabetes, insulin
10 Participants7 Participants3 Participants
Diabetes diagnosis
Gestational diabetes, oral agents
5 Participants1 Participants4 Participants
Diabetes diagnosis
Type 1 Diabetes
1 Participants1 Participants0 Participants
Diabetes diagnosis
Type 2 Diabetes
5 Participants4 Participants1 Participants
Discharged on antihypertensive medication88 Participants47 Participants41 Participants
Drug use status
Current users
1 Participants0 Participants1 Participants
Drug use status
Former users
7 Participants6 Participants1 Participants
Employment status
Employed
141 Participants75 Participants66 Participants
Employment status
Self-employed
9 Participants4 Participants5 Participants
Employment status
Unemployed
63 Participants33 Participants30 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
120 Participants67 Participants53 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
93 Participants45 Participants48 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Exposure to magnesium sulfate78 Participants44 Participants34 Participants
Gestational age at delivery
20-23 6/7 weeks
1 Participants0 Participants1 Participants
Gestational age at delivery
24-27 6/7 weeks
4 Participants3 Participants1 Participants
Gestational age at delivery
28-33 6/7 weeks
20 Participants12 Participants8 Participants
Gestational age at delivery
34-36 6/7 weeks
36 Participants16 Participants20 Participants
Gestational age at delivery
37-38 6/7 weeks
94 Participants52 Participants42 Participants
Gestational age at delivery
39-40 6/7 weeks
55 Participants26 Participants29 Participants
Gestational age at delivery
>41 weeks
3 Participants3 Participants0 Participants
Highest level of education
College
51 Participants25 Participants26 Participants
Highest level of education
Declined to answer
3 Participants3 Participants0 Participants
Highest level of education
Elementary school
2 Participants1 Participants1 Participants
Highest level of education
Graduate School
61 Participants35 Participants26 Participants
Highest level of education
High school
53 Participants26 Participants27 Participants
Highest level of education
Some college
34 Participants16 Participants18 Participants
Highest level of education
Some high school
9 Participants6 Participants3 Participants
Married/Partnered165 participants76 participants89 participants
Multiparous164 Participants81 Participants83 Participants
Neonatal disposition
Fetal Demise
1 Participants1 Participants0 Participants
Neonatal disposition
Neonatal Demise
1 Participants1 Participants0 Participants
Neonatal disposition
Neonatal intensive care unit (NICU) admission
47 Participants28 Participants19 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
16 Participants11 Participants5 Participants
Race (NIH/OMB)
Black or African American
64 Participants32 Participants32 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
28 Participants19 Participants9 Participants
Race (NIH/OMB)
White
103 Participants48 Participants55 Participants
Religion
Christian
112 Participants57 Participants55 Participants
Religion
Hindu
2 Participants0 Participants2 Participants
Religion
Jehovah's Witness
3 Participants3 Participants0 Participants
Religion
Jewish
11 Participants4 Participants7 Participants
Religion
Muslim
6 Participants4 Participants2 Participants
Religion
None
71 Participants37 Participants34 Participants
Religion
Other
8 Participants7 Participants1 Participants
Sex: Female, Male
Female
213 Participants112 Participants101 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Smoking status
Current Smokers
1 Participants0 Participants1 Participants
Smoking status
Former Smokers
11 Participants6 Participants5 Participants
Time of initiation of prenatal care
First trimester
166 Participants84 Participants82 Participants
Time of initiation of prenatal care
No prenatal care
1 Participants0 Participants1 Participants
Time of initiation of prenatal care
Second trimester
39 Participants24 Participants15 Participants
Time of initiation of prenatal care
Third trimester
3 Participants1 Participants2 Participants
Time of initiation of prenatal care
Unknown
4 Participants3 Participants1 Participants
Type of delivery
Cesarean Delivery
113 Participants56 Participants57 Participants
Type of delivery
Forceps-assisted Vaginal Delivery
4 Participants3 Participants1 Participants
Type of delivery
Spontaneous Vaginal Delivery
96 Participants53 Participants43 Participants
Type of hypertension
Chronic Hypertension
29 Participants14 Participants15 Participants
Type of hypertension
Eclampsia
1 Participants0 Participants1 Participants
Type of hypertension
Gestational Hypertension
71 Participants38 Participants33 Participants
Type of hypertension
Preeclampsia without severe features
29 Participants12 Participants17 Participants
Type of hypertension
Preeclampsia with severe features/HELLP Syndrome
62 Participants36 Participants26 Participants
Type of hypertension
Superimposed preeclampsia
21 Participants12 Participants9 Participants
Type of insurance
Private Insurance
125 Participants65 Participants60 Participants
Type of insurance
Public Insurance
88 Participants47 Participants41 Participants
Type of prenatal care
Generalist
117 Participants62 Participants55 Participants
Type of prenatal care
Maternal fetal medicine (MFM)
88 Participants45 Participants43 Participants
Type of prenatal care
No prenatal care
8 Participants5 Participants3 Participants
Urgent antihypertensive medication antepartum or intrapartum36 Participants21 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1120 / 101
other
Total, other adverse events
0 / 1120 / 101
serious
Total, serious adverse events
7 / 11213 / 101

Outcome results

Primary

Blood Pressure (BP) Surveillance Adherence

Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment

Time frame: Up to 14 days from delivery hospitalization discharge

ArmMeasureValue (MEDIAN)
Usual CareBlood Pressure (BP) Surveillance Adherence0.0 percentage of recommended BPs reported
Remote Patient MonitoringBlood Pressure (BP) Surveillance Adherence61.1 percentage of recommended BPs reported
Secondary

Communications

Number of communications between patient and obstetric provider

Time frame: Up to 14 days post delivery hospitalization discharge

ArmMeasureValue (MEAN)
Usual CareCommunications0.12 Communications
Remote Patient MonitoringCommunications0.57 Communications
Secondary

Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge

Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy

Time frame: Up to 8 weeks from delivery

Population: The analyzed population only includes participants who were not on medications at the time of discharge.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Initiated on Antihypertensive Therapy After Hospital Discharge10 Participants
Remote Patient MonitoringNumber of Participants Initiated on Antihypertensive Therapy After Hospital Discharge24 Participants
Secondary

Number of Participants Readmitted

Number of participants who were readmitted after delivery hospitalization discharge

Time frame: Up to 8 weeks from delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Readmitted7 Participants
Remote Patient MonitoringNumber of Participants Readmitted13 Participants
Secondary

Number of Participants Referred to Primary Care for Continued Blood Pressure Management

Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit

Time frame: Up to 8 weeks from delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Referred to Primary Care for Continued Blood Pressure Management31 Participants
Remote Patient MonitoringNumber of Participants Referred to Primary Care for Continued Blood Pressure Management38 Participants
Secondary

Number of Participants Who Developed Preeclampsia-associated Complications

Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.

Time frame: Up to 8 weeks from delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Who Developed Preeclampsia-associated Complications4 Participants
Remote Patient MonitoringNumber of Participants Who Developed Preeclampsia-associated Complications9 Participants
Secondary

Number of Participants With ED Visit

Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge

Time frame: Up to 8 weeks from delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With ED Visit17 Participants
Remote Patient MonitoringNumber of Participants With ED Visit25 Participants
Secondary

Number of Participants With Outpatient BP Assessment Within 14 Days

Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home)

Time frame: Up to 14 days from delivery hospitalization discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Outpatient BP Assessment Within 14 Days69 Participants
Remote Patient MonitoringNumber of Participants With Outpatient BP Assessment Within 14 Days59 Participants
Secondary

Number of Participants With Outpatient PP Assessment

Number of participants who had an outpatient postpartum (PP) assessment

Time frame: Up to 8 weeks from delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Outpatient PP Assessment88 Participants
Remote Patient MonitoringNumber of Participants With Outpatient PP Assessment82 Participants
Secondary

Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit

Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at the postpartum visit

Time frame: Up to 8 weeks from delivery

Population: The analyzed population only includes participants who had an outpatient postpartum assessment.

ArmMeasureValue (NUMBER)
Usual CarePercentage of Participants With Elevated Blood Pressure at the Postpartum Visit13.6 percentage of participants
Remote Patient MonitoringPercentage of Participants With Elevated Blood Pressure at the Postpartum Visit17.1 percentage of participants
Secondary

Percentage of Participants With Elevated BP After Discharge

Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at outpatient blood pressure assessment

Time frame: Up to 14 days from delivery hospitalization discharge

Population: 1 participant in the Usual Care group attended but did not have BP recorded at outpatient visit. 2 participants in the Remote Patient Monitoring group attended but did not have BP recorded at outpatient visit.

ArmMeasureValue (NUMBER)
Usual CarePercentage of Participants With Elevated BP After Discharge27.9 percentage of participants
Remote Patient MonitoringPercentage of Participants With Elevated BP After Discharge24.5 percentage of participants
Secondary

Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)

The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.

Time frame: Up to 8 weeks from delivery

Population: This questionnaire was not given to the Usual Care group since they did not participate in a telemedicine program.~There were 52 respondents to the survey in the remote patient monitoring group.

ArmMeasureValue (MEAN)Dispersion
Remote Patient MonitoringScore on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)4.03 score on a scaleStandard Deviation 0.95
Secondary

Score on the Philips Program Start Survey and the Philips Program End Survey

The Philips program start survey is a 4-question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6-question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The number reported is the average score for each group.

Time frame: Baseline, program end (up to 8 weeks from delivery)

Population: The analyzed population only includes participants who completed both the Start Survey and the End Survey.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareScore on the Philips Program Start Survey and the Philips Program End SurveyBaseline (Start Survey)4.77 score on a scaleStandard Deviation 0.71
Usual CareScore on the Philips Program Start Survey and the Philips Program End SurveyProgram End (End Survey)4.59 score on a scaleStandard Deviation 0.82
Remote Patient MonitoringScore on the Philips Program Start Survey and the Philips Program End SurveyBaseline (Start Survey)4.57 score on a scaleStandard Deviation 2.23
Remote Patient MonitoringScore on the Philips Program Start Survey and the Philips Program End SurveyProgram End (End Survey)4.55 score on a scaleStandard Deviation 0.85
Secondary

Time to Medication Initiation

Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)

Time frame: Up to 8 weeks from delivery

Population: The analyzed population only includes participants in each arm who were not on medications at the time of discharge.

ArmMeasureValue (MEDIAN)
Usual CareTime to Medication Initiation6.5 days
Remote Patient MonitoringTime to Medication Initiation6.0 days
Secondary

Total Percentage of Elevated Blood Pressure Readings

Of all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as \>/=140 systolic or \>/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first).

Time frame: Up to 14 days from delivery hospitalization discharge

Population: The analyzed population only includes participants who recorded at least one blood pressure at home after hospital discharge.

ArmMeasureValue (NUMBER)
Usual CareTotal Percentage of Elevated Blood Pressure Readings37.52 percentage of elevated BP readings
Remote Patient MonitoringTotal Percentage of Elevated Blood Pressure Readings49.6 percentage of elevated BP readings

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026