A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
Phase: NA
Conditions: Hypertensive Disorder of Pregnancy
Sponsor: Columbia University

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Title:  A remote postpartum blood pressure surveillance and reminder system for 
hypertensive disorders of pregnancy: a randomized clinical trial 
Applicant: Jessica Spiegelman, MD  
Attending Principal Investigator: Leslie Moroz, MD 
1. Proposal abstract
The overarching goals of our study are to (i) assess whether implementation of a Bluetooth-
enabled remote blood pressure monitoring system improves monitoring of women with 
hypertensive disorders of pregnancy (HDP) in the postpartum period, (ii) assess whether 
improved monitoring improves blood pressure control and reduces morbidity in this patient 
population and (iii) evaluate the factors associated with poor postpartum follow up among 
patients with HDP. HDP, an umbrella term which includes chronic hypertension with or without 
superimposed preeclampsia, gestational hypertension, preeclampsia with or without severe 
features, HELLP syndrome and eclampsia, affect nearly 10% of pregnancies and are some of the 
most common conditions encountered by obstetricians.1 In the postpartum period, hypertension 
can be related to persistence of pre-existing HDP, or it can develop de novo postpartum.2 HDP 
are an important cause of maternal morbidity and mortality, and a leading cause of postpartum 
readmission.3 Therefore, the American College of Obstetricians and Gynecologists (ACOG) 
recommends that in women with HDP, blood pressure should be monitored inpatient or with 
equivalent outpatient surveillance for at least 72 hours postpartum and again at 7-10 days after 
delivery.1 The majority of patients, however, are discharged on postpartum day 2 or 3, often prior 
to this 72-hour mark and almost always prior to the 7-10 day mark. Even if they are discharged 
home with a plan for outpatient surveillance and follow-up, postpartum follow-up rates are 
known to be low: in one secondary analysis of postpartum follow-up and persistent hypertension 
in women with severe preeclampsia, the 6-week follow-up rate was 52%. Of those patients who 
did follow up, 21% had persistent hypertension.4 With low-follow up rates and high rates of 
persistent hypertension in those that do follow up, clearly there is a large subset of women with 
continued hypertension who are simply lost to care. Barriers to care for women in the postpartum 
period include lack of consistent provider, lack of understanding of discharge instructions and 
difficulties with transportation. Additionally, many women have difficulty managing their own 
health issues when also taking care of a newborn.5 Therefore, a proactive approach to monitoring 
BP as an outpatient in the postpartum period that involves minimal patient burden is needed to 
identify women with poorly controlled BP, adjust antihypertensive medications, and prevent 
hypertension-associated morbidity.  
Remote blood pressure monitoring offers a possible solution to this problem. In a randomized 
control trial design, we propose to use a Philips Remote Patient Monitoring (RPM) System to 
assess whether we can improve blood pressure monitoring during this critical period. RPM has 
been shown repeatedly in the non-obstetric literature to improve hypertension management by 
increasing the amount of patients’ involvement in their own care, and providing physicians with 
more dynamic control of patients’ blood pressure.6 We hypothesize that a Bluetooth-enabled 
blood pressure monitoring system will lead to closer monitoring and improved communication 
NCT03728790 
Version Date: July 22, 2020

 
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between patients and their providers. Ultimately, we hypothesize that this will lead to earlier 
initiation and more active titration of anti-hypertensive medications, earlier recognition of and 
intervention for women at risk of significant hypertension-related morbidity and decreased rates 
of maternal morbidity and mortality.  
 
2. Proposal body 
 
2.1 Background 
There is a paucity of data on the diagnosis and management of HDP in the postpartum period. 
The natural history of postpartum HDP is poorly understood, and estimates of the prevalence of 
the disease vary widely, ranging from 0.3 to 27.5%.7 In older studies of patients who had planned 
postpartum inpatient stays of 1 week or longer, 12% of previously normotensive women became 
hypertensive and >50% of women with HDP had a systolic/diastolic BP ≥ 150/100 mmHg.8,9 
Since those studies were performed, the length of a hospital admission for delivery has 
shortened. Most women are now discharged within 48-72 hours of delivery, and many are not 
evaluated again until their traditional 6-week postpartum visit. However, nearly 20% of women 
who deliver a baby in the United States will be seen and discharged from an emergency 
department prior to their traditional 6-week postpartum visit, and an additional 1-2% of patients 
will be admitted.10 In a 2016 study, hypertension was found to be the second most common 
cause of postpartum readmission in the United States, after infection.11 Short-term complications 
that are known to occur secondary to uncontrolled HDP include stroke, seizure, pulmonary 
edema, posterior reversible encephalopathy syndrome, renal or hepatic dysfunction, and death.12 
HDP is also a risk factor for the long-term development of cardiovascular disease, hypertension, 
stroke and renal disease.13 Given all of these associated short-and long-term morbidities, close 
follow up of women with HDP is essential in the postpartum period and beyond. Yet due to the 
scarceness of empiric data on postpartum BP, there are limited recommendations regarding the 
initiation, frequency, and duration of postpartum BP monitoring in women with HDP.14  
ACOG guidelines recommend that in women with HDP, blood pressure should be monitored in 
the hospital or with equivalent outpatient surveillance for at least 72 hours postpartum and again 
7-10 days after delivery, or earlier in women with symptoms.1 At CUIMC, the usual care for 
discharge of patients with HDP at CUIMC involves the following (hereafter referred to as “usual 
care”): 
1. A prescription for a blood pressure cuff and instructions to measure blood pressures twice 
daily at home. No make or model is specified, and the patient is responsible for obtaining 
the device from a pharmacy. 
2. Arrangements for a nursing service to visit the patient’s home for a blood pressure check 
within the first few days after discharge. The exact timing of this is not standardized; for 
example, if the patient is discharged on Friday, the nurse may come 72 hours later on 
Monday; if the patient is discharged on Thursday, the nurse may come 24 hours later on 
Friday. 
3. An appointment for a blood pressure check in the clinic where the patient received 
prenatal care at 7-10 days postpartum; the patient is instructed to bring logs of their twice 
daily blood pressure measurements to this visit. Patients with private insurance are told 
to make this appointment with their prenatal care provider but are not given the 

 
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appointment prior to discharge. Patients who are discharged on or after 7 days 
postpartum are told to follow up in one week 
4. An appointment for a 6-week postpartum visit. Patients with private insurance are told to 
make this appointment with their prenatal care provider but are not given the 
appointment prior to discharge. 
 
If followed in full by the patient, these policies do follow the current guidelines set forth by 
ACOG. However, extrapolating from the limited published data regarding follow-up rates and 
from approximations from our own publicly-insured population, it is reasonable to presume that 
only about half of these patients present for their one-week blood pressure check appointment.15 
Poor follow-up is not a problem unique to our institution. In a secondary analysis of factors 
associated with postpartum follow-up and persistent hypertension in women with severe 
preeclampsia by Levine et al, the 6-week follow-up rate was 52%. Among those with 6-week 
follow-up, 21% had persistent hypertension.4 With low-follow up rates and high rates of 
persistent hypertension in those that do follow up, clearly there is a large subset of women with 
continued hypertension who are simply lost to care. Barriers to care in the postpartum period 
include lack of a consistent provider, lack of understanding of discharge instructions whether due 
to poor health literacy, a language difference or a failure of the provider to properly explain 
instructions, and difficulties with transportation. Additionally, many women have difficulty 
managing their own health issues when also taking care of a newborn, possibly with limited 
support.16 
Postpartum care in general in the United States leaves something to be desired, and has been the 
subject of many studies aiming to determine how we can improve delivery of care to these 
patients.17 In May of 2018, citing the urgent need to reduce severe maternal morbidity and 
mortality in the United States, ACOG released a committee opinion on the “fourth trimester,” 
referring to the critical but oft-neglected postpartum period. It proposes a restructuring of 
postpartum care from a single visit at the 6-week mark to an ongoing process with services and 
support tailored to each woman’s individual needs. Women with HDP should have blood 
pressure evaluation within 7-10 days postpartum, and women with severe hypertension should be 
seen within 72 hours.18 Blood pressure assessment in this time period is critical, as more than 
50% of postpartum strokes occur within 10 days of discharge.19 Early identification and 
treatment of women with poorly controlled HDP could meaningfully reduce the hypertension-
associated morbidity and mortality in this population. 
Mobile health technologies have been shown to be useful, both in improving outcomes and in 
improving patient connectedness to care, both in obstetrics and in other disciplines.20,21 In the 
non-obstetric population, RPM has been shown to improve treatment of hypertension.6 RPM has 
also been studied in pregnancy and the postpartum period in limited contexts. In one such study, 
where patients self-selected into an RPM program for blood pressure monitoring postpartum, 
RPM patients reported fewer perceived barriers to care than their usual-care counterparts.22 In 
another, women randomized to text-based reminders to check blood pressures had a significantly 
higher rate of recorded blood pressure readings in the first ten days postpartum compared to 
those randomized to an in-office blood pressure check.15 Studies such as these are scarce, and 
there remains a lack of good-quality evidence on the usefulness and efficacy of RPM in patients 
with HDP. 

 
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Our study proposes that the use of mobile health technology, specifically a Bluetooth-
enabled blood pressure cuff, will improve the care of women with hypertension in the 
postpartum period by increasing the amount of blood pressure data collected in the 
outpatient setting. Increased data and closer surveillance will allow for more active 
titration of anti-hypertensive medications and assessment of symptoms. We also propose 
that patients will feel more involved in and connected to their care using RPM.   
 
2.2 Specific aims  
Our objective is to trial 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.  
 
Specific Aim 1. 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. We hypothesize that women using RPM will have more 
blood pressure values recorded at outpatient blood pressure assessment compared with patients 
using the usual care. 
• Sub-aim 1: To compare the percentage of elevated blood pressures that are 
discussed with an obstetric care provider between patients who have been enrolled 
in an RPM trial to those who are being treated with the usual care. We hypothesize 
that women using RPM will communicate more frequently with their providers regarding 
elevated blood pressure values.  
• Sub-aim 2: To examine the effect of RPM on blood pressure control at 6 weeks in 
women with HDP. We hypothesize that more women using RPM will be normotensive, 
defined as blood pressure < 140/90 mm Hg, at the end of the postpartum period, 
compared to those randomized to usual care.  
Sub-aim 3: To compare time to outpatient initiation or adjustment of 
antihypertensive medications in women using RPM compared to the usual care. We 
hypothesize that women using RPM will have shorter time to initiation of medications or 
shorter time to change in medication regimen in the outpatient setting than those using 
the usual care. 
Specific Aim 2. To compare rates of compliance with follow up visits between patients who 
have been enrolled in an RPM trial to those who are being treated with the usual care. We 
hypothesize that women using RPM will have a higher rate of compliance with outpatient blood 
pressure assessments and postpartum visits than patients using the usual care 
• Sub-aim 1: To analyze factors associated with poor postpartum follow up in both 
the study group and the control group. We hypothesize that factors such as 
socioeconomic status, wait times at the office or clinic where care is provided, number of 
children at home, and educational level will be associated with lower follow-up rates.   
Specific Aim 3. To assess the ease of use and satisfaction for RPM. We hypothesize that 
women who use RPM will be satisfied with this method of blood pressure monitoring, and will 

 
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feel overall more connected to their care and to their providers than women who receive the 
usual care. 
 
2.3. Methods 
 
2.3.1 Study Design 
This will be a randomized control trial, in which women with HDP diagnosed prior to delivery 
will be assigned to either usual care or to a telehealth kit that, supplied by Philips. New York 
Presbyterian has a contract in place with Philips (attached separately to this IRB application 
under “Philips Contract 5.30”) which allows the hospital to utilize Philips telehealth programs 
for its patients. The telehealth kit will include a Bluetooth-enabled blood pressure cuff which is 
FDA approved to monitor blood pressure as well as pulse, and a tablet that includes a clinical 
monitoring software (eCareCoordinator, or eCC). Further details regarding the devices are 
outlined in the “Equipment and Software” section below.  
Patients will be recruited from the postpartum service. All patients will be asked to check their 
blood pressure twice per day, once in the morning and once in the evening. Pulse will also be 
recorded as it is taken automatically at time of blood pressure reading; though this parameter is 
not being studied, there will be protocols in place to address abnormal values. Control group 
patients will use the blood pressure cuff that they procure after discharge using the prescription 
they are given, and will be asked to keep a log of their blood pressure measurements. Study 
group patients will use the Philips Bluetooth-enabled blood pressure cuff, which will transmit 
blood pressure measurements via Bluetooth from the monitor to the eCC. These patients will be 
educated on the use of and enrolled in the software by Philips representatives (via telephone) and 
research investigators who have been in-serviced on the devices prior to discharge. The tablets 
are cellular-enabled, so no wireless connection is needed in the patient’s home.  
Measurements and surveys for patients in the study group will be scheduled in the eCC (see 
“HDP Calendar and Intervention Rules,” attached as a separate document to this IRB 
application). Data for patients in the study group will be transmitted to the Philips Clinical Call 
Center, staffed daily by nurses from 8am-8pm. The nurses will review measurements and survey 
results within 2 hours when they are flagged as high for attention. Criteria for flagging and 
therefore review by a nurse as well as for escalation to an obstetric provider is outlined in the 
workflow attached as separate documents to this IRB (“HDP calendar and intervention rules” / 
“Workflows”). If a measurement is flagged as high, the nurse will contact the patient and the 
patient’s provider (if the patient has not) by phone. The patient will also be automatically 
instructed via the system to call their provider immediately. If a measurement is flagged as low, 
the nurse will email the patient’s provider with a summary of the day’s measurements at the end 
of the day. If a patient does not enter measurements, the nurse will contact the patient directly. If 
the patient does not enter measurements for 3 consecutive days, the nurse will contact the 
patient’s provider, and will continue attempting to contact the patient daily. If a nurse cannot get 
in touch with the patient, the nurse will contact the patient’s provider. If a survey answer is 
flagged, the nurse will contact the patient and the patient’s provider (if the patient has not) by 
phone. The patient will also be automatically instructed via the system to call their provider 
immediately. If the patient does not answer a survey, the nurse will contact the patient the 

 
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following day. For all patients, regardless of whether or not they have flagged values, a weekly 
report of measurements will be generated and sent to the patient’s providers every week.  
Patients in both groups will be given an appointment to follow-up with their obstetric provider in 
the office at 7-10 days postpartum. Control group patients will be asked to bring a log of their 
recorded blood pressures to this visit. The number of measurements total and the number of 
measurements that were elevated will be ascertained for each group at this visit.  
Patients in the study group will also be prompted to answer a daily survey within the Philips 
application regarding symptoms of preeclampsia, a weekly survey regarding their medications 
and satisfaction surveys prior to and at the conclusion of the study period. Patients in the control 
group will also be given satisfaction surveys prior to and at the conclusion of the study period. 
Patients in both groups will be followed from recruitment until the date of their postpartum visit. 
Flowcharts illustrating the above work flows can be found in separate attachments to this IRB 
application (“HDP calendar and intervention rules” / “Workflows”). 
2.3.2 Inclusion Criteria 
Women who meet the following criteria will be eligible for the study: 
1) Postpartum women 
2) Antepartum diagnosis of hypertension, defined as existing chronic hypertension diagnosis 
or documented blood pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions 
at least 4 hours apart prior to delivery 
3) At least 18 years of age 
4) English or Spanish speakers 
2.3.3 Exclusion Criteria 
1) Non-English or Spanish speakers 
• The consent form will only be available in these 2 languages 
2) Lives outside of NY State, unless their physician is licensed in the state of residence 
• The telemedicine laws in NJ prohibit physicians from practicing telemedicine 
unless licensed in NJ; the NYP legal team is investigating if this is true for other 
states 
3) Women who are not planning on obtaining their postpartum follow up at CUIMC  
4) Women who are physically unable to hold or use the tablet 
5) Women who do not have a working phone 
6) Women whose obstetric providers are unable or unwilling to implement escalation 
pathways 
7) Women who were diagnosed with hypertension postpartum 
 
2.3.4 Recruitment, Screening and Enrollment 
We will use a recruitment strategy designed and utilized by the OB department. An OB research 
coordinator (RC) will perform daily chart screen of all women admitted to the CUIMC 
postpartum unit (CHONY 5 central, 6 central and 10 central). Permission from healthcare 
providers will be obtained prior to the OB RC contacting participants. Eligible women will then 
be recruited from the aforementioned postpartum units. After obtaining written informed 

 
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consent, participants’ sociodemographic characteristics will be collected. Information regarding 
their diagnosis of HDP and delivery information will be collected at that time as well. They will 
then be randomized to either usual care, as defined above, or the study group. Randomization 
will occur in REDCap. Those in the study group will be educated on use of the Philips 
equipment by research personnel who will have been educated on use of the equipment, with 
support over the phone by a Philips representative. Nursing staff will be familiarized with the 
equipment as well, and will be available to answer any questions the patient might have. Patients 
in the study group will be provided with the Philips telehealth kit, complimentary of participating 
in the study, prior to being discharged from the hospital (see “Equipment and Software” section, 
below). Their chart will be created in the eCC prior to discharge from the hospital by the RC.  
Once home, the patient will receive a “Welcome Call” from a Philips representative, which will 
ensure that the equipment is set up properly and that all the patient’s questions are answered. If 
the patient has any remaining difficulty with equipment, Philips will arrange for a home visit 
from a representative, which will occur within 72 hours. Prior to that visit, if the Bluetooth 
system is not working properly, the cuff will still work as a normal blood pressure cuff, so the 
patient will be able to take measurements.  
 
2.3.5 Equipment and Software 
The usual care group will be given a prescription for a blood pressure cuff. In general, the 
prescription does not specify a model of cuff; this is up to the discretion of the pharmacist or the 
patient.  
 
The study group will receive a Philips Home Telehealth Solution kit, complimentary of 
participating in the study, which includes several FDA/FCC approved devices. NewYork-
Presbyterian has a contract in place with Philips (attached separately to this IRB application 
under “Philips Contract 5.30”) which allows the hospital to utilize Philips telehealth programs 
for its patients. The investigators had no role in the signing of this contract and have no 
financial interests in this program. The following equipment is included in the Philips kit: 
 
Device 
US 510(k) 
A&D 
Blood Pressure Meter, regular or small 
cuff version 
UA-767PBT-Ci 
Class II 
K043217 
FCC:POOWML-C40 
eCareCoordinator (eCC) Suite 
K171029 
Samsung Galaxy Tab E 8.0" 
model SM-T377A 
Not a medical device, no associated 510(k) 
FCC: A3LSMT377A 
 

 
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The instructions that patients will receive for use of the tablet and the blood pressure meter are 
attached separately to this IRB application (“Philips patient instructions”/ ”A&D Cuff 
Instructions”).   
The eCC Clinical User Guide is also attached separately to this IRB application (“eCC Clinical 
User Guide for Version 1.6”). It outlines the use of the applications contained within the eCC 
Suite for both patients and providers, including the metrics that can be collected for each patient.  
The most relevant components of this document are listed below. The page numbers listed refer 
to the page number within the PDF document and not the page number found in the bottom right 
corner of each page.  
• Patients view (p.24-25): describes the columns of information that are available for 
review and analysis 
• Overall score/flag values (p.27-29): describes how clinical data is flagged for review 
• Hospital admissions/ED visits (p.73-76): describes how hospital admissions and ED 
visits are tracked within the patient chart.  
• Calendar (p.79-80): illustrates the patient tasks expected each day in a calendar format. 
These tasks may include surveys, measurements, clinician tasks, appointments and sticky 
notes.  
•  Surveys (p.86-89): describes how surveys are displayed as part of the calendar and how 
they can be accessed. The surveys that will be available as part of this study are attached 
as a separate document to this IRB application (“Surveys”). They include: 
• Preeclampsia Symptom Survey-scheduled 
• Preeclampsia Symptoms Survey-reflexive, high acuity 
• Preeclampsia Symptoms Survey-reflexive, low acuity 
• Medication Survey 
• Satisfaction Survey-Program Start (will also be given to the control group) 
• Satisfaction Survey-Program End (will also be given to the control group) 
• Telemedicine Survey Specific-Program End 
• Measurements (p.91-92): describes how patient measurements are displayed and 
scheduled. For this study, only blood pressure and heart rate will be measured.  
• Patient issues (p.128-137): describes how acute conditions that affect daily patient care 
activities are monitored and how chronic problems are tracked.  
• Reviewing flags and issues (p.142-146): describes how patients are flagged for clinical 
assessment and intervention, and how these flags and issues are reviewed and addressed 
• Intervention rules (p.188- 210): conditional statements that consist of a condition and an 
action that the system will trigger when the condition is met. The intervention rules for 
this study are attached to the IRB application as a separate document (“HDP 
calendar and intervention rules”) and workflows can be found as a separate 
document as well (“Workflows”).  
At the conclusion of the 6-week study period (in other words, after the scheduled postpartum 
visit or the time when that visit was supposed to occur, if the patient did not present), the patient 

 
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will be expected to return the kit. The full patient terms of use are attached to this IRB 
application as a separate document (“Philips Terms of Use”).  
2.3.6 Outcomes 
1) Primary outcome: Our primary outcome will be percentage of the recommended twice 
daily blood pressures reported between hospital discharge and outpatient blood pressure 
assessment.   
2) Secondary outcomes: Secondary outcomes will include: 
1. Percentage of recorded blood pressure values during that time frame that are 
elevated (>140 systolic OR >90 diastolic) 
2. Percentage of elevated blood pressures that triggered a phone call to an obstetric 
provider 
3. Rate of attendance at outpatient  blood pressure assessment  
4. Incidence of elevated blood pressure at the outpatient blood pressure assessment 
5. Rate of outpatient assessment for postpartum care  
6. Incidence of elevated blood pressure at the postpartum assessment 
7. Time to initiation of antihypertensive medications (in patients who were not on 
medications at time of discharge) and adjustment of antihypertensive medications 
8. Final dosage of antihypertensive medications at 6 weeks postpartum 
9. Readmission rate 
10. Rate of emergency department visits 
11. Rate of HDP-associated morbidities (e.g.: stroke, seizure, PRES) 
12. Percentage of patients who require a referral to primary care physicians after 
being discharged from obstetric care at the postpartum visit 
13. Patient satisfaction with the method, to be assessed via a validated clinical survey 
(attached separately in the document entitled “Surveys”).  
 
2.3.7 Measures 
The following data will be collected for analysis. 
 
1) To be collected on enrollment/prior to hospital discharge: 
1. Demographic and social factors. Date of birth, self-reported race/ethnicity, 
cultural background [place of birth (US or not), years living in the US, and 
primary language spoken in the home, marital status, highest level of maternal 
education attained, employment status, household income,  insurance status and 
city of residence/zip code will be elicited from the patients on enrollment 
2. Pregnancy history. On enrollment, participants will be asked about the number 
and outcomes of prior pregnancies 
3. Prenatal care history. Location of prenatal care, GA on initiation of prenatal 
care and number of prenatal visits will be extracted from the EHR when possible 
and verified by the participant on enrollment.  

 
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4. Delivery history. Mode of delivery and baby’s disposition will be collected on 
enrollment 
5. Medical history. Other medical history will be extracted from the EHR and 
verified by the participant on enrollment 
6. Health behaviors. Current and prior smoking, alcohol, and illicit drug use will be 
elicited on enrollment. 
7. Weight and height. Height, pre-pregnancy weight, first documented weight 
during the pregnancy, and weight at enrollment, will be obtained on enrollment 
and extracted from the EHR. Body mass index (BMI) will be calculated as height 
(cm)/weight (kg)2. 
8. Blood Pressure. Blood pressure history, including time of diagnosis of 
hypertensive disorder, precise HDP diagnosis and exposure to magnesium sulfate 
or antihypertensive medications will be ascertained on enrollment and verified 
prior to discharge. 
9. Hospital length of stay. defined as days AFTER delivery that the patient is 
admitted to the hospital; this will be ascertained upon hospital discharge 
10. Medications. discharge antihypertensive medications will be collected upon 
discharge  
2) To be collected throughout the study period: 
1. Blood pressures. For the control group, participants will be asked to provide a 
record of the blood pressures they are recording at home, and the blood pressures 
from their office visits will be recorded as well. For the study group, participant 
blood pressures will be stored in eCC, and the blood pressures from any in-person 
visits will be recorded as well. Percentage of scheduled blood pressure readings 
that are recorded will be compared between groups. Incidence of elevated blood 
pressures during this time will also be compared between groups.  
2. Communication. Rate of communication between patient and obstetric provider 
for each abnormal blood pressure measurement will be compared between groups.  
3. Adherence. For both groups, rate of presentation for scheduled appointments will 
be collected. For the study group, eCC will collect patient reports of reasons why 
they were unable to check their blood pressure or attend a scheduled appointment 
4. Time to initiation of medications. For both groups, time to initiation of anti-
hypertensive medications will be tracked 
5. Final plan at 6 weeks. For both groups, continuing medication regimens at 6 
weeks will be collected.  Referral to primary care physician will be collected.  
6. Hospital readmissions. Hospital readmission for any indication will be collected 
for both groups 
7. ED visits. Presentation to the emergency department for any indication will be 
collected for both groups 
8. Maternal morbidity and mortality. Incidences of eclampsia, stroke, PRES, 
maternal death and other preeclampsia-associated morbidities will be collected for 
both groups 
9. Home Health Services: information regarding the use of home health services 
after discharge including referral to home health services, number of visits and 
blood pressure at those visits will be collected for both groups 
 

 
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2.3.8 Definitions 
Chronic hypertension will be defined according to ACOG guidelines as blood pressure 
measurement of EITHER ≥140 mm Hg OR diastolic ≥90 mm Hg on at least 2 occasions, at least 
4 hours apart, prior to 20 weeks gestation 1 
Hypertensive disorders of pregnancy will be defined according to ACOG guidelines.1 The 
minimum criteria for a diagnosis of HDP are as follows: 
• Blood pressure measurement of EITHER systolic ≥140 mm Hg OR diastolic ≥90 mm Hg 
on at least 2 occasions, at least 4 hours apart, between 20 weeks gestation and delivery 
• Blood pressure measurement of EITHER systolic ≥160 mm Hg OR diastolic ≥110 mm 
Hg on at least 2 occasions qualifies as severe features 
 
The following investigations are routinely undertaken in the clinical setting once HDP is 
identified in order to further categorize HDP into more specific diagnoses. These results will be 
reviewed for each patient to ensure the correct diagnosis has been assigned to the patient. Blood 
pressure findings as above with none of the findings listed in the table below satisfies a diagnosis 
of gestational hypertension. 
Type of test 
Cutoffs 
Diagnosis 
Urine 
-24-hour protein 
concentration > 300 mg 
OR 
-Protein/Creatinine ratio > 0.3 
 
Preeclampsia  
Serum 
-Platelets <100,000/microliter 
OR 
-Creatinine >1.1 mg/dL, or 
doubling from baseline 
OR 
-LFTs > twice the upper limit 
of normal concentration or 
twice baseline 
 
Preeclampsia with severe 
features  
Signs/symptoms: any of the 
following, if not accounted 
for by another diagnosis 
-New-onset, refractory 
cerebral or visual 
disturbances 
-Severe persistent right upper 
quadrant or epigastric pain 
unresponsive to medication  
-Pulmonary edema 
-Blood pressure ≥ 160 
systolic OR ≥110 diastolic 
Preeclampsia with severe 
features 
Serum 
-Platelets <100,000/microliter  
AND 
-Evidence of hemolysis 
Hemolysis, elevated liver 
enzymes and low platelet 
count (HELLP) syndrome 

 
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2.4 Statistical Analyses 
 
2.4.1 Sample size and statistical power 
Though data on the rate of follow up in patients with HDP are scarce, we will presume that the 
percentage of patients who record their blood pressures accurately postpartum is similar to the 
rate noted in the few studies that have measured similar metrics, approximately 43.7%.15 We 
currently have IRB approval for a retrospective study to assess the postpartum follow up of 
women with HDP over the past 2 years at CUIMC (protocol AAAR9887). Until data collection 
for this study is complete, we will not precisely know the baseline rate of compliance with blood 
pressure measurements in the first 7-10 days postpartum. Therefore, in order to err on the side of 
making sure we are well powered, we will use 60% as an estimated percentage of twice daily 
blood pressures that are recorded in the usual care group. Aiming to achieve a rate of 80% for 
twice daily blood pressure recordings in the study group with 80% power, we would need to 
recruit 81 patients to each group. Allowing for the possibility of loss to follow-up and to 
compensate for the reduced power due to statistical adjustment for potential confounders, we 
inflated the sample size by 25%. 101 patients will therefore need to be recruited to each group, or 
202 patients total. The randomization sequence was built based on an overestimate of dropout 
rate. Therefore, we increased our target enrollment from 202 to 220. Once the sample size is 
reached, enrollment will stop. 
 
2.4.2 Statistical analysis 
For analysis of discrete (categorical) data in independent samples, the Chi-squared test or Fisher 
exact probability test will be utilized. For group comparisons, continuous data that satisfy the 
assumptions of normality and homoscedasticity (homogeneity of variance) will be analyzed by t-
test (for 2 independent samples) or analysis of variance (>2 groups, ANOVA) with post hoc 
comparisons by Scheffe tests. When possible, continuous data that do not fulfill the 
aforementioned assumptions will be mathematically transformed (e.g., logarithmic 
transformation) before performing t-tests or ANOVA. In some cases, data that do not satisfy 
these assumptions will be analyzed by nonparametric methods [Mann-Whitney U Test (for two 
independent samples) or Kruskal-Wallis One-Way ANOVA (for more than two independent 
AND 
-LFTs > twice the upper limit 
of normal concentration or 
twice baseline 
 
Signs/symptoms 
New-onset, grand mal 
seizure, with no history of 
seizure disorder and not 
accounted for by any other 
diagnosis 
Eclampsia 

 
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samples)]. Significant Kruskal-Wallis ANOVAs will be followed by Dunn tests for post hoc 
analysis. The degree of linear association between variables will be measured by the Pearson 
product moment correlation coefficient or the Spearman rank-order correlation coefficient and 
their corresponding tests of significance. Multivariate linear or logistic regression will be utilized 
where appropriate. In all cases, statistical significance will be assumed when p<0.05. Propensity 
score analysis will be used as a balancing score as deemed necessary. 
 
2.4.3 Strengths and limitations 
Strengths of our study include a randomized control design, as well as a large cohort of patients 
who will be eligible for enrollment. CUIMC has 9 obstetric clinics which annually experience 
27,612 deliveries, of which 2,853 (approximately 160/month) are affected by HDP. An 
additional strength of our study is that the Philips RPM system has been previously tested in pilot 
studies at other institutions and is currently being trialed in a 30-day pilot program in the 
Emergency Department at CUIMC, projected to end in mid-October 2018, prior to the projected 
start of this study. If there are any unforeseen issues with equipment or installment, these will be 
able to be resolved prior to the rollout of our study.   
 
Project limitations include potential fear among patients of a new technology that could limit 
enrollment. Additionally, patients may not present to their 7-10 day postpartum blood pressure 
check, which would limit the results; however, we did try to account for this when calculating 
our sample size. Finally, a limitation of the study is that control patients may be more cognizant 
of checking their blood pressures due to being enrolled in a research protocol, and this may 
falsely inflate their blood pressure recording rates. However, even if the control group has higher 
compliance with blood pressure measurements than the baseline population, we still anticipate 
that the study group will have a statistically significant increase in these measurements.  
 
2.5. Anticipated outcomes  
The primary outcome will be the difference in the percentage of twice-daily blood pressures 
reported between hospital discharge and the outpatient blood pressure assessment. We anticipate 
that the patients enrolled to RPM will have a significantly higher percentage of blood pressures 
recorded. Thus, there will be more data, available at an earlier time point in the postpartum 
period, which providers can use to make decisions regarding titrating medications and need for 
closer monitoring. We anticipate that patients enrolled in RPM will have more communication 
with their obstetric providers, higher compliance with their scheduled postpartum visits, and 
better blood pressure control at 6 weeks postpartum. We also anticipate that these patients will 
feel like they have had a more active role in their own care, and will feel more connected to their 
providers during the fragile and currently under-monitored postpartum period.  
 
2.6. Significance  
There are several knowledge gaps in the postpartum management of women with HDP. The 
short term postpartum course of BP in women with HDP and time to normalization of BP in 
women with HDP have not been well described. Clinical characteristics associated with the 

 
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duration of postpartum HTN and the adherence to and tolerability of RPM in the postpartum 
state are unknown. These knowledge gaps have important clinical implications and answering 
them will provide valuable information regarding the feasibility of out-of-office BP monitoring 
in order to care for women with HDP, who have been shown to have extremely low rates of 
follow-up and adherence to care. The overall goal of this project is to collect empiric data for 
future guidelines on the optimal use of RPM among postpartum women with HDP. 
 
2.7 Timeline  
Enrollment is planned to begin in early November of 2018, as soon as IRB approval is granted 
and the pilot program is complete in the Emergency Department (currently ongoing and 
projected to end mid-October 2018). This pilot program aims to trial the use of the Philips RPM 
system with Emergency Department patients, to ensure feasibility of use. We plan to recruit 
patients from the postpartum service after delivery. The sample size required is 101 patients per 
group. We anticipate that these patients will be successfully recruited into the study within a 6-
month period, ending approximately in April to May of 2019. These patients will need to be 
followed until 6 weeks postpartum. We anticipate that the study will be completed by July 2019. 
 
2.8. Environment 
The Columbia Department of OB/GYN brings substantial experience and skill in organizing and 
participating in clinical research.  We have a strong track record in all areas of collaborative 
research including protocol design, implementation, data analysis and dissemination of findings.  
Our productivity is facilitated by a number of factors: (1) A critical mass of academic full time 
faculty with sufficient time and skill to perform clinical research, (2) the presence of a diverse 
patient population willing to participate in research initiatives, and (3) an established research 
environment in which clinicians accept participation in research initiatives as a major role of a 
teaching institution.  This has led to a longstanding reputation for excellence in clinical research. 
 
Of utmost importance is our research infrastructure with a proven record of success, which is 
embedded in the elaborate system of prenatal clinics and obstetric services and complemented by 
our large and diverse population of over 6,600 deliveries per year, advanced support systems, 
strong division of Neonatology, outstanding follow-up programs and a patient population proven 
to be receptive to participation in research.  The research staff is trained and certified in Good 
Clinical Practice, HIPPA, Blood Borne Pathogen Handling, and IATA Shipping Regulations. All 
staff is capable of collecting patient samples, cord blood and placental processing (including 
RNA, proteomics and DNA). Our research staff of over 25 individuals are trained and certified 
in each ongoing project.  This maximizes efficiencies in recruitment and the performance of 
study procedures and also allows staff to share the responsibility of on-call coverage. 
 
The Department of OB/GYN maintains a centralized administrative research office that manages 
pre- and post-award grant administration, and oversees roughly $10 million in sponsored 
research funding annually. The Office analyzes, monitors, and evaluates the Department’s 
research activities including all federal and non-federal sponsored awards and contracts. They 

 
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ensure the efficient, cost-effective administration and financial management and ensure 
compliance with internal and external policies and procedures.  
 
2.9. Investigators  
We are uniquely qualified to perform this project, as we are in a large medical center, with a 
diverse patient population. Our research study will take place at Columbia University, a large 
academic center actively involved in a myriad of academic studies. The principal investigator, 
Dr. Leslie Moroz, completed fellowships in both Maternal-Fetal Medicine and Critical Care 
Medicine. She is the director of the Mothers Center, which provides comprehensive, 
multidisciplinary care for pregnant women with medical or surgical complications. She has a 
particular interest in developing programs that can safely provide remote postpartum care, to 
ease the burden of care while increasing the amount of monitoring during this critical period. She 
is also a dedicated teacher and mentor in the residency and Maternal-Fetal Medicine fellowship 
program at Columbia University. Dr. Jessica Spiegelman, a fellow in Maternal-Fetal Medicine, 
began her research early on in her career as an undergraduate student, and established her interest 
in clinical outcomes research in the community, as reflected in her peer reviewed publications. 
Her interest and commitment to the field of obstetrics and Maternal-Fetal Medicine continued on 
residency, where she established presence in the high risk obstetrics community as a contributor 
to research and to caring for patients in under-served populations.   
 
Additionally, expertise for this research project includes an experienced, interdisciplinary team. 
Dr. Natalie Bello, who is a board-certified cardiologist with special interest in pregnant women, 
is the PI of a K23 grant investigating the use of home blood pressure monitoring and novel 
methods of clinic BP measurement in pregnant women with HTN. She is also 
involved in the conduct and examination of epidemiological studies designed to elucidate the 
relationship between HDP and CV disease, including the California Teachers Study and 
nuMom2b Heart Health Study (HHS) (clinicaltrials.gov NCT02231398). Her short- and long-
term career goals include the design and conduct of clinical trials to evaluate BP measurement, 
monitoring, and treatment during pregnancy and in the postpartum period to improve 
maternalfetal outcomes. 
 
Support for database construction and management will primarily come from Cynthia Masson, 
Director of Clinical Information System Design and Innovation and head of the Columbia 
University’s Department of Obstetrics and Gynecology Interdepartmental CORE Data Team. 
She has assisted multiple single and multi-center funded and unfunded studies in obtaining and 
capturing research, clinical and operational data and providing a stream-lined process for 
building complex databases and translating complex data for seamless data analysis.  
 
As part of a major academic research center, we additionally have the continued support of 
medical students, residents and experienced research assistants. 
 
 

 
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References 
 
1 Hypertension in pregnancy. Report of the American College of Obstetricians and 
Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122:1122-1131 
2 Goel A, Maski MR, Bajracharya S, Wenger JB, Zhang D, Salahuddin S, Shahul SS, Thadhani 
R, Seely 
EW, Karumanchi SA, Rana S. Epidemiology and mechanisms of de novo and persistent 
hypertension in the postpartum period. Circulation. 2015;132:1726-1733 
3 Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related 
mortality in the United States, 2006-2010. Obstet Gynecol. 2015;125:5-12 
4 Levine LD, Nkonde-Price C, Limaye M, Srinvas SK. Factors associated with postpartum 
follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 
2016;36(12):1079–82 
5 Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the 
postpartum visit among women living in healthy start project areas. Maternal and child health 
journal. 2006; 10(6): 511–6 
6 Albini, F., Xiaoqiu, L., Torlasco, C., Soranna, D., Faini, A., Ciminaghi, R., Parati, G. An ICT 
and mobile health integrated approach to optimize patients' education on hypertension and its 
management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study. Conf 
Proc IEEE Eng Med Biol Soc, 2016, 517-520.  
7 Sibai, BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet 
Gynecol. 2012 Jun;206(6):470-5 
8 Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clinical 
science (London, England : 1979). 1986;71:589-594 
9 Walters BN, Walters T. Hypertension in the puerperium. Lancet. 1987;2:330 
10 Clark SL, Belfort MA, Dildy GA, et al. Emergency department use during the postpartum 
period: implications for current management of the puerperium. Am J Obstet Gynecol 
2010;203:38.e1-6 
11 Clapp A, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions 
in the United States. Am J Obstet Gynecol 2016; 215:113.e1-10 
12 Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed 
Postpartum Preeclampsia and Eclampsia: Demographics, Clinical Course, and Complications. 
Obstet Gynecol 2011; 118(5):1102–1107 
13Bushnell C, McCullough LD, et al; on behalf of the American Heart Association Stroke 
Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; 
Council on Epidemiology and Prevention; Council for High Blood Pressure Research. 

 
Spiegelman et al 
 
18
 
Guidelines for the prevention of stroke in women: a statement for healthcare professionals from 
the American Heart Association/American Stroke Association. Stroke. 2014;45:1545–1588 
14 Wenger NK, Arnold A, Bairey Merz CN, Cooper-DeHoff RM, Ferdinand KC, Fleg JL, Gulati 
M, Isiadinso I,  Itchhaporia D, Light-McGroary K, Lindley KJ, Mieres JH, Rosser ML, Saade 
GR, Walsh MN, Pepine CJ. Hypertension across a woman's life cycle. J Am Coll Cardiol. 
2018;71:1797-1813 
15 Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-
based remote monitoring in the management of postpartum hypertension: a randomised clinical 
trial BMJ Qual Saf Published Online First: 27 April 2018. 
16 Bryant AS,  Haas  JS,  McElrath  TF,  et  al. Predictors of compliance with the postpartum visit 
among women living in healthy start project areas. Matern Child Health J. 2006;10:511-516 
17 Tully KP, Stuebe AM, Verbiest SB. The fourth trimester: a critical transition period with 
unmet maternal health needs. Am J Obstet Gynecol. 2017 Jul;217(1):37-41 
18 Optimizing Postpartum Care. ACOG Committee Opinion No. 736. American College of 
Obstetricians and Gynecologists. Obstet Gynecol 2018; 131:e140-50. 
19 Too G, Went T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, et al. Timing and Risk 
Factors of Postpartum Stroke. Obstet Gynecol 2018;1:70–8 
20 Gandapur Y, Kianoush S, et al. The role of mHealth for improving medication adherence in 
patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 
2016 Oct; 2(4): 237–244. 
21 Arnhold M, Quade M, Kirch W. Mobile applications for diabetics: a systematic review and 
expert-based usability evaluation considering the special requirements of diabetes patients age 50 
years or older. J Med Internet Res. 2014;16(4):a. 
22 Rhoads SJ, Serrano CI, et al. Exploring Implementation of m-Health Monitoring in Postpartum 
Women with Hypertension. Telemed J E Health. 2017 Oct;23(10):833-841