Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial
Phase: NA
Conditions: Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome
Sponsor: Prisma Health-Upstate

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Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring (PHANTOM) 
 
Principal Investigator: Renata Sawyer, MD 
Co-Investigators: Lauren Demosthenes, MD, Brittany J. Arkerson, MD, Eric Dellinger, MD, Matthew 
Finneran, MD, Solita Harris, MD, David Soper, MD, Stella Self, PhD, and John Van Deman, MD 
 
Version: 03.09.2021 
 
NCT: 04823949 
 

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A. Objective 
 
To compare standard in-office postpartum blood pressure monitoring to at-home monitoring for patient 
diagnosed with hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia with or 
without severe features, and chronic hypertension with superimposed pre-eclampsia) with regard to 
identification of elevated blood pressures, adherence to ACOG guidelines for blood pressure 
monitoring, timing of the identification and treatment of elevated blood pressures, readmission, and 
patient satisfaction 
 
B. Background 
 
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, 
including gestational hypertension and pre-eclampsia. New ACOG guidelines recommend postpartum 
monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 
postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood 
pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in 
performing the recommended postpartum follow-up for patients with hypertensive disorders of 
pregnancy. 
 
C. Study Methodology 
 
1. Study Design 
 
Randomized controlled trial 
 
2. Comparison Groups: 
 
1: Control group: 
 
A. Standard monitoring: Postpartum blood pressure checks in the outpatient 
setting on postpartum days 7-10 
 
2: Intervention group: 
 
B. At-home monitoring: Postpartum blood pressure checks twice a day for 16 
days using supplies and phone app provided by Babyscripts 
 
3. Procedures: 
 
Identification of Potentially Eligible Patients 
 
1. Potentially eligible patients identified in the postpartum period at GMH and MUSC 
based on documented diagnosis of pregnancy-related hypertension in the antepartum, 
intrapartum, or postpartum period  
 
 
Study Enrollment 
 
2. The patient is approached for study participation by a member of the study staff 
3. The enrollment process involves a face-to-face interview with study staff for verification 
of study eligibility and counseling regarding study procedures, potential benefits and 
risks, prior to obtaining written consent.  
4. Enrollment will occur on the post partum unit in the hospitals 
 
Treatment Allocation 
 

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5. Patients will be randomized to group 1 or group 2 
6. Subjects allocated to group 1 
A. Undergo counseling regarding standard postpartum blood pressure 
monitoring with outpatient blood pressure checks on days 7-10 postpartum. 
They will receive appointments for this at the time of discharge from the 
hospital.  
 
7. Subjects allocated to group 2 
A. Undergo teaching of how to use Babyscripts app and blood pressure cuff 
B. Explanation of timing and frequency of blood pressure checks and explanation 
of when to expect call/text from a provider 
C. Assurance that mobile phone number listed in the chart is correct 
D. See flowsheet at the end of this document for decision tree regarding patient 
contact and treatment of blood pressures 
 
4. Outcomes: 
 
1. Primary: percentage of patients with blood pressure ascertainment within the first 10 
days following discharge 
2. Secondary outcomes:  
A. Adherence to ACOG guidelines for postpartum blood pressure monitoring 
o 
Defined as blood pressure ascertainment at 72 hours and between 7-10 
post delivery 
B. Rates of initiation of anti-hypertensive medication 
C. Rates of readmission and postpartum triage utilization 
D. Timing of the identification and treatment of severe blood pressures (>/= 
160/100). See flow diagram for further details 
E. Patient satisfaction with question scored by a 5 point Likert scale 
F. Subgroup analysis of primary outcome stratified by White and Non-White race 
 
5. Study Population: 
 
All postpartum women at GMH and MUSC with a diagnosis of gestational hypertension, 
pre-eclampsia with or without severe features which also includes chronic hypertension 
with superimposed preeclampsia 
 
6. Inclusion Criteria: 
 
1. 
Age >18 
2. 
English is primary language 
3. 
Ability to receive calls and unlimited texts 
4. 
Unlimited texting on cell phone 
5. 
Can receive phone calls on cell phone 
6. 
Arm can accommodate BP cuff 
 
7. Exclusion Criteria: 
 
1. 
BMI >50 
2. 
English not primary language 
3. 
Unable to receive phone calls on cell phone 
4. 
Does not have unlimited texting capability on cell phone 
 
8. Allocation Method 
 
Randomization will be done after consent is obtained by block randomization in REDCap  

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9. Withdrawals, Losses and Deviations 
 
As the primary outcome is ascertainment of blood pressure within 10 days of discharge, 
we will be observing if patients do not participate in their group’s allocated care; they will 
not be removed from their study group  
 
10. Data Collection/Outcome Measurement 
 
Baseline patient characteristics will be obtained on enrollment. Subject outcomes will be 
catalogued by the research staff via chart review. REDCap will be utilized for data 
collection. 
 
11. Study Size and Power 
 
Our sample size calculation for this study is based upon a prior published study 
investigating postpartum blood pressure ascertainment in a similar population of women 
with hypertensive disorders of pregnancy by Hirshberg et al. In their cohort, a blood 
pressure was obtained in 43.7% of patients in the usual care group versus 92.2% in the 
text-based blood pressure monitoring group. We will assume a slightly more conservative 
estimate of 50% blood pressure ascertainment in the usual care group and 70% in the text-
based group. With a two-sided alpha of 0.05% and 80% power, we would need to enroll 
93 patients in each arm for a total population of 186.  
 
12. Analytic Plan 
 
• 
Intention to treat analysis 
• 
No exclusions for protocol violations or post-randomization exclusions 
• 
Calculation of RR and 95% CI for primary outcome 
• 
Univariate analysis of independent variables 
 
D. Possible Risks 
 
Minimal risk to the patient is associated with this study. The most likely risk to the patient would be loss 
of confidentially. If a patient is started on antihypertensive therapy, it is possible that side effects from 
the chosen medicine may be experienced. However, the medications used for treatment are standard 
of care for patients outside of the study as well.  
 
E. Possible Benefits 
 
This research study is not expected to directly benefit individual subjects, but is likely to yield 
generalizable knowledge which contributes to the field. It may benefit individual patients by identifying 
an elevated blood pressure earlier than standard of care.  
 
 
 

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F. Special Precautions 
 
Patients will be given adequate time to review the consent form after being counseled on the study, 
and will be given adequate time to have questions and concerns answered. 
 
Research staff will be trained in protection of patient confidentially.  Captured data will be maintained 
on password protected electronic files, accessed through password protected computers that are 
housed behind locked office doors. 
 
The study protocol has been reviewed with other medical centers who have already deployed this 
process. Their experience has shown this to be safe and feasible 
 
G. Procedures to Maintain Confidentiality 
 
Individual patient data collected as part of this investigation will remain confidential.  Composite results 
from this investigation, however, will be disseminated to the scientific community.  The data sheet will 
contain the patient’s name and medical record number for later chart review.  Actual data collection will 
only be performed by the investigators for their study or their designated research personnel.  Once 
the data is collected, each patient will be assigned an alpha-numeric identifier which will allow entry of 
de-identified data in a computer database. The original data sheets will be stored in a secure location 
in the Department of Obstetrics and Gynecology. 
 
 
 
 
 
 
 
 
 
 
 

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*1st line: Labetalol 200 mg BID 
  2nd line: nifedipine 30 mg qd 
 
** 1st line: Labetalol 300 mg BID 
     2nd line: nifedipine 60 mg qd 
 
***If she has started the medicine 
 
 
 
 
 
Patient takes 
her BP 
<140/90 
≥140/90 to 
<160/100 
≥160/100 
Repeat within 
15 mins
Symptomatic 
Clinic or Triage  
Asymptomatic 
<150/100 
≥150/100 
Continue 
scheduled 
monitoring 
Initiate 
antihypertensive 
therapy* 
<90/60 
Call to discuss 
dose reduction 
Still 
≥150/100 
Up-titrate** 
Still 
≥150/100 
Call for provider 
visit*** 
≥160/100 
Clinic or Triage 
<150/100 
≥150/100 
Continue 
scheduled 
monitoring 
Initiate antihypertensive 
therapy* and subsequent 
monitoring/adjustments** 
Continue 
scheduled 
monitoring