Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled
Phase: NA
Conditions: Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Hypertension; Maternal
Sponsor: Vanderbilt University Medical Center

Comprehensive Postpartum Management for Women with  
Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial 
Protocol 
Updated 4/4/2023 
Primary Investigator: 
Sarah Osmundson, MD, MS 
Maternal-Fetal Medicine 
Alex Phelps, MD 
Maternal-Fetal Medicine Fellow 
Co-Investigators: 
Julia Phillippi, PhD, CNM 
School of Nursing 
Soha Patel, MD, MSPH 
Maternal-Fetal Medicine 
Etoi Garrison, MD, PhD 
Maternal-Fetal Medicine 
Kathryn Lindley, MD 
Cardiology 
Neha Dudipala, BA 
Department of Obstetrics & Gynecology 
Funding:  
R21NR020857-01 
ClinicalTrials.gov number: NCT05849103 

 
 
BACKGROUND 
Hypertension complicates 10% of pregnancies in the U.S.,1 directly accounting for 7% of pregnancy-related 
deaths2 and 38% of severe maternal morbidity.3,4 Hypertensive disorders of pregnancy (HDP) include chronic 
hypertension, gestational hypertension, preeclampsia, hemolysis-elevated-liver enzymes-low platelets 
(HELLP), and eclampsia, and occur 2.5 times more frequently among Black compared to non-Black patients.5 
The weeks after delivery are crucial for maternal health, severe maternal morbidity, and hypertension-
associated morbidity.6,7 Half of all pregnancy-related deaths occur in this time8 and Black patients are impacted 
disproportionally by these morbidities including pulmonary edema, stroke, and renal failure.9,10  
 
The American College of Obstetricians and Gynecologists (ACOG) recently redefined postpartum care to 
encompass 12 months after birth and stressed the importance of connecting postpartum patients to primary 
care clinicians to manage chronic conditions.11 This handoff is critical as 50% of patients with HDP develop 
chronic hypertension, and patients affected by HDP have twice the risk of later cardiovascular-related 
death.12,13 Recently, Tennessee expanded Medicaid coverage to 12 months postpartum.14 Given that most 
obstetric clinicians do not provide comprehensive primary care, we urgently need models for bridging gaps in 
care after pregnancy. While interventions such as telemedicine and peer navigation demonstrate promise to 
improve patient engagement in care and reduce postpartum racial disparities,15–18 no randomized trials 
address system-level initiatives to improve postpartum care for patients with HDP.19,20 
 
Another area of active investigation relates to establishing appropriate blood pressure targets for patients in 
and around the time of pregnancy. Recent findings from the Chronic Hypertension and Pregnancy Trial 
suggest that stricter control of antepartum blood pressure is beneficial in reducing the incidence of a composite 
adverse perinatal outcome which included preeclampsia with severe features, medically indicated preterm birth 
at less than 35 weeks of gestation, placental abruption, and fetal or neonatal death. This trial has been 
practice-changing, lowering the historic antepartum blood pressure target from 160/110mmHg to less than 
140/90mmHg. However, this trial did not contemplate management of maternal blood pressure in the 
postpartum period. ACOG presently endorses a postpartum goal of less than 150/100mmHg which, notably, is 
higher than the newly established antepartum goal. Furthermore, the blood pressure target set for non-
pregnant adults by the American College of Cardiology and American Heart Association is even lower, at less 
than 120/80mmHg to minimize the cardiovascular disease risk associated with chronic hypertension. 
We propose a comprehensive management program for postpartum patients with HDP who are at risk for 
severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring 
of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure 
management directed by a program navigator with guideline and physician support and 3) facilitated transitions 
of care to primary care clinicians for hypertension management. We will randomize 1400 patents with HDP on 
postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure 
control at 2 weeks postpartum. Secondary outcomes include identification and treatment of severe blood 
pressures, severe maternal morbidity, postpartum and primary care visit attendance, and multiple patient-
reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate 
disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood 
pressure control on outcomes. We hypothesize that a comprehensive postpartum HDP management program 
will improve hypertension control for all patients and reduce disparities that affect Black patients, and that 
stricter blood pressure control will be associated with fewer adverse outcomes.   
 
OBJECTIVE 
 
Specific Aim 1: To assess whether augmented remote blood pressure monitoring and tight blood pressure 
control, both individually and in combination, improve blood pressure control and the frequency of severe 
hypertension in the first 2 weeks postpartum. 
Specific Aim 2: To test whether these interventions narrow the existing Black/non-Black inequity in postpartum 
outcomes such as blood pressure control and severe hypertension. 
 

 
 
ELIGIBILITY CRITERIA 
 
Inclusion Criteria 
1. Age >18 years  
2. Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, 
preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low 
Platelets), or eclampsia (O10, O11, O13, O14, O15, O16) 
Exclusion Criteria 
1. Not able or willing to receive electronic surveys 
2. Deemed inappropriate for study enrollment by bedside nurse 
3. Non-English speaking 
4. Discharge on postpartum day 6 or greater 
5. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke) 
 
SCREENING 
 
An Epic Dashboard will be used to screen eligibly patients using the following criteria: 
• 
Admitted to the following units: 4 North, 4 South, 4 East, 4 Med Center East 
• 
Age >18 years 
• 
Problem list containing the following ICD10 codes: O10, O11, O12, O13, O14, O15, O16 
• 
Preferred language is English 
 
ENROLLMENT 
 
Patients will be approached for enrollment in the study in their private hospital rooms. Research personnel will 
discuss potentially eligible patients with either the bedside nurse or charge nurse prior to approaching patients 
to determine any concerns about enrollment.  
 
Recruiting Script: “Hello Ms. [Patient Last Name]. I am [Research Assistant Name] and I am a research 
assistant at Vanderbilt. I was hoping to talk to you about a study we are doing among patients who have had 
high blood pressure issues during pregnancy or postpartum.” 
 
Patients Who Express Interest: “We want to learn how to better help patients who have high blood pressure in 
pregnancy. All women who have high blood pressure in pregnancy should see their obstetric provider within 
one week of leaving the hospital to watch blood pressure closely. We want to learn the best way to provide 
blood pressure care. If you join the study, you would be placed randomly into a group. You would either see 
your OB as usual for blood pressure help or manage your blood pressure electronically with help from a 
special team. You would still see your OB for regular postpartum follow up and questions. You would also be 
grouped by different blood pressure goals. As part of the study, we will look at your health record to learn about 
your delivery and any health issues. We only share this information with the research team and not your OB. 
You will get $50 if you finish all 3 months of the study. Risks of the study are small but could include over-
treatment, meaning that medication to control blood pressure may be given without added benefit to you, and 
sharing of health information by accident.” 
 
Once a patient expresses interest in participating, they will be given the informed consent document 
electronically delivered (via text web-link or email link to RedCap) and their e-signature will be obtained if they 
consent to participation. 
 

 
 
STUDY PROCEDURES 
 
u Enrollment: After consenting to the study, participants will receive the initial survey via text web-link or 
email link. Survey 1 asks questions about the participant’s hypertension history, experience with prenatal 
care and care at delivery, and socio-demographic questions not reliably obtained from the electronic health 
record. We estimate that this survey will take 15 minutes to complete. Participants will receive a $10 gift 
card for completion. 
u Randomization and Procedures before Hospital Discharge: All participants will receive an Omron 
validated blood pressure monitor with appropriately sized cuff (Appendix A) following measurement of their 
arm circumference. Many of our patients do not obtain blood pressure cuffs postpartum, and they 
infrequently are covered by insurance providers. Instructions for blood pressure measurements and 
discharge instructions will be discussed with the patient and sent via MyHealth messaging with the script 
described in Appendix B. Participants will be instructed to measure blood pressure after being seated for 
10 minutes with legs uncrossed and back supported with their arm positioned at the level of their heart. 
They will be instructed to avoid caffeine and tobacco for 30 minutes prior to measuring blood pressure. If 
blood pressures reach a predefined target threshold (Interventions C and D), they should wait 15 minutes 
and repeat the blood pressure measurement. Participants will be instructed to bring their blood pressure 
cuff to their first follow up appointment for calibration and clinical correlation. At hospital discharge, 
participants will receive information regarding follow up after HDP: a) seeking care for sustained severe 
blood pressures (>160/110 mmHg at least 15 minutes apart), b) preeclampsia alert symptoms (headache, 
confusion, or visual changes), and c) scheduling an appointment with a primary care clinician at 3 months 
postpartum. All patients will receive a written letter explaining the study (Appendix C) that they can take to 
clinician visits outside the VUMC system. At discharge, a follow up in-person visit for a blood pressure 
check within 7-10 days postpartum will be requested by the inpatient team, which is our routine practice. 
Our specific research interventions are:   
u Interventions: Participants will be randomized in a 1:1:1:1 ratio in permuted blocks of 4-12 to one of four 
interventions as summarized in Table 1 and described in detail below. Randomization will be generated 
through sealedenvelope.com and allocation through REDCap. Randomization will be stratified by race. 
Blood Pressure Care Navigation  
(A) Obstetric Provider Monitoring (In-Person): Participants will be instructed to check their blood pressures 
twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or 
symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be 
directed by their obstetric clinician. 
(B) Augmented Remote Blood Pressure Monitoring: A physician investigator (fellow or attending) will place 
an order for “MyHealth BP Flowsheet” in the participant’s chart, which triggers the Track My Health feature 
on MyHealth. The research assistant will demonstrate to the participant how to track blood pressures 
through the Track My Health feature on the MyHealth smartphone app. Blood pressure monitoring and 
management plan outlined below. Among women on antihypertensive medication, blood pressure tracking, 
monitoring, and feedback will continue until care has been transferred to a clinician who can provide long-
term care.    

 
 
 
Participant and Hypertension Program Manager responsibilities described in detail below: 
Table 2. Participant and Hypertension Program Manager Responsibilities 
Blood Pressure 
Monitoring 
Participants  
Responsibilities 
Hypertension Program Manager 
Responsibilities 
 
Weeks 1-2 after 
delivery 
}Check blood pressures twice daily 
}Record BPs every day in MyHealth 
}Seek urgent care (triage, ED) for 
sustained severe HTN or symptoms 
}Receive BPs notifications daily M-F 
}Call patients who do not send BPs 
}Adjust antihypertensive medications 
based on sections (C) and (D) below 
 
Weeks 3-6 after 
delivery 
}Check blood pressures once daily 
}Record BPs daily in MyHealth 
}Seek urgent care (triage, ED) for 
sustained severe HTN or symptoms 
}Receive BPs notifications weekly 
}Adjust antihypertensive medications 
based on sections (C) and (D) below 
Communication with 
obstetric clinicians  
 
}Send updates on HTN management at 
weeks 2, 4, and 6 
}Document medication changes in EStar 
}Send updates to non-VUMC obstetric 
clinicians with any antihypertensive 
medication changes 
Care Handoffs 
}Schedule postpartum visit at 4-6 
weeks 
}Schedule a visit with a primary care 
clinician or cardiologist at month 3 
}Ensure that postpartum visits are 
scheduled by 4-6 weeks 
}Ensure that primary care or cardiology 
visits are scheduled at month 3 
}Remind patients about all visits 
Blood pressure Control 
(C) Standard Blood Pressure Control: Blood pressure targets will be <150 mmHg systolic and <100 mmHg 
diastolic consistent with current postpartum recommendations from ACOG. Blood pressure notifications for 
the HTN program navigator will reflect these parameters and medications will be initiated or titrated to meet 
these goals. See Appendix J for specifics on management and Appendix L for recommended medication 
regimens 
(D) Tight Blood Pressure Control: Blood pressure targets will be <140 mmHg systolic and <90 mmHg 
diastolic. Blood pressure notifications for the HTN program navigator will reflect these parameters and 
medications will be initiated or titrated to meet these goals. See Appendix K for specifics on management 
and Appendix L for recommended medication regimens. 
u Survey 2 (6-weeks after delivery): Participants will receive the survey via text web-link or email link. Survey 
2 asks questions about the participant’s experience managing hypertension after delivery, the Mothers On 
Respect Index (MORI) and the Communication Assessment Tool geared towards postpartum care, the 
PROMIS Bank v1.0 Anxiety (adaptive) survey, the PROMIS Bank v1.0 Depression (adaptive) survey, the 
PROMIS Bank v2.0 Instrumental Support (adaptive) survey, We estimate that this survey will take 20 
minutes to complete. Participants will receive a $20 gift card for completion of this survey. 
u Survey 3: (12-weeks after delivery): Participants will be contacted via SMS text or email to ask about follow 
up with a primary care physician and chronic hypertension. Participants will receive a $20 gift card for 
completion of this survey. 
 

 
 
OUTCOMES 
Primary Outcomes: The outcome for the R21 and listed on ClinicalTrials.gov is the proportion of patients with 
a blood pressure recorded in the office at 7-10 days postpartum (BPinperson). It is not hypothesized that the 
primary outcome varies by the blood pressure control intervention but will vary by the blood pressure 
management intervention.  
Secondary Outcomes: We will examine three categories of secondary outcomes (Table 3). Hypertension 
control and adverse events includes measures of blood pressure control and events potentially associated with 
poor blood pressure control such as severe maternal morbidity (SMM) and hospital readmission. Given that 
our intervention tests different models of care, we will assess health care utilization associated with these 
models including adherence to in-person and remote blood pressure monitoring, medication use, attendance at 
scheduled visits, and unscheduled visits to an urgent care or emergency room. 
We will also examine a variety of patient-reported outcome measures especially satisfaction with care. HDP 
carries not only a risk of long-term health sequelae, but also post-traumatic stress disorder, depression, and 
anxiety.92,93 In a review of patients’ experiences with HDP, the potential for worsening or chronic hypertension 
was associated increased feelings of anxiety and loss of agency.94 We hypothesize that augmented remote 
monitoring and tighter blood pressure control, both individually and in combination, will improve postpartum 
blood pressure control within the first six weeks postpartum. We also hypothesize that participants, especially 
Black participants, will find the results of these interventions satisfying and acceptable as they provide a nexus 
of agency during otherwise stressful life events. Observed reductions in blood pressure provide more frequent 
and immediate feedback to participants relative to other meaningful outcomes such as SMM or hospital 
readmission. We also acknowledge the possibility that patients also could find frequent observation of blood 
pressures and tighter parameters to be burdensome or increase anxiety about health status.   
While postpartum patient-reported outcome measures have been developed and validated to study inpatient 
recovery, lack of consensus exists regarding optimal measures of  outpatient recovery.95 In a recent systematic 
review of validated measures used to assess three domains or more of outpatient postpartum recovery, three 
measures were identified but all had significant limitations.96 The authors conclude that assessment may be 
better achieved using existing methods such as those endorsed by the Patient-Reported Outcomes 
Measurement Information System initiative (PROMIS).96 Therefore, we selected validated PROMIS and NIH 
Toolbox measures related to depression, anxiety, and social support. Because experience of being listened to 
or being ignored and dismissed are central drivers of Black women’s pregnancy and postpartum experience 
and health outcomes,38,39 we emphasize outcomes related to communication during and satisfaction with 
clinical encounters such as the Communication Assessment Tool -Team (CAT-T) and the Mothers on Respect 
index (MORi), a scale developed to assess the nature of respectful patient-provider interactions and their 
impact on a person’s sense of comfort, behavior, and perceptions of racism or discrimination.  
 
VARIABLE NAME 
DESCRIPTION 
DERIVATION 
VALUE 
7-10 Day Outcomes 
BPinperson710 
BP recorded in person  
None 
1=yes 
0=no 
BPremote710 
Any BP recorded remotely  
A systolic BP (d710sbp_remote) or a 
diastolic BP (d710dbp_remote) value is 
is present 
1=yes 
0=no 
BPany710 
Any BP recorded in person or remotely  
If BPinperson710 = 1 or BPremote710=1 
1=yes 
0=no 
SBP710 
SBP value  
Selected by the following hierarchy: 1) in person 
SBP, 2) remote SBP - If multiple remote BP 
values were submitted, selected the SBP from day 
8 and average the values.  
SBP710 = d710sbp_inperson if 
d710sbp_inperson is present. If 
d710sbp_inperson is absent, then use 
d710sbp_remote. 
Continuous 
DBP710 
DBP value 
Selected by the following hierarchy: 1) in person 
DBP, 2) remote DBP - If multiple remote BP 
DBP710 = d710dbp_inperson if 
d710dbp_inperson is present. If 
Continuous 

 
 
values were submitted, selected the DBP from day 
8 and average the values.  
d710dbp_inperson is absent, then use 
d710dbp_remote. 
SBP710_bin 
SBP value >= 140 
SBP710 >=140 
1=yes 
0=no 
DBP710_bin 
DBP value >= 90 
DBP710 >=90 
1=yes 
0=no 
ANYhigh_bin 
Any BP value >=140/90  
SBP710>= 140 OR DBP710>= 90 
1=yes 
0=no 
SBPsevere710_bin 
SBP value >= 160 
SBP710 >=160 
1=yes 
0=no 
DBPsevere710_bin 
DBP value >= 110 
DBP710 >=110 
1=yes 
0=no 
ANYsevere_bin 
Any BP value >=160/110  
SBP710>= 160 OR DBP710>= 90 
1=yes 
0=no 
dcp_medstart 
Any medication started between discharge 
through week 6 after delivery 
n/a 
1=yes 
0=no 
dcpp_medstart 
Days postpartum that medication was started 
n/a 
Continuous 
readmit 
Hospital readmission 
n/a 
1=yes 
0=no 
 
The two co-primary outcomes are mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) 
recorded in-office (Table 3). In a secondary analysis, we will also include mean blood pressure measurements 
reported via augmented remote monitoring among women who do not attend in-office visits. The third co-

 
 
primary outcome is proportion of participants with sustained severe hypertension during the first 6 weeks 
postpartum defined as a SBP >160 or a DBP >110 on two occasions at least 15 minutes apart.  
Secondary Outcomes  
We will examine three categories of secondary outcomes (Table 3). Hypertension control and adverse events 
includes measures of blood pressure control 
and events potentially associated with poor 
blood pressure control such as severe 
maternal morbidity (SMM) and hospital 
readmission. Given that our intervention tests 
different models of care, we will assess health 
care utilization associated with these models 
including adherence to in-person and remote 
blood pressure monitoring, medication use, 
attendance at scheduled visits, and 
unscheduled visits to an urgent care or 
emergency room. 
We will also examine a variety of patient-
reported outcome measures especially 
satisfaction with care. HDP carries not only a 
risk of long-term health sequelae, but also 
post-traumatic stress disorder, depression, 
and anxiety.92,93 In a review of patients’ 
experiences with HDP, the potential for 
worsening or chronic hypertension was 
associated increased feelings of anxiety and 
loss of agency.94 We hypothesize that 
augmented remote monitoring and tighter 
blood pressure control, both individually and in 
combination, will improve postpartum blood 
pressure control within the first six weeks 
postpartum. We also hypothesize that 
participants, especially Black participants, will 
find the results of these interventions 
satisfying and acceptable as they provide a 
nexus of agency during otherwise stressful life 
events. Observed reductions in blood pressure 
provide more frequent and immediate 
feedback to participants relative to other 
meaningful outcomes such as SMM or 
hospital readmission. We also acknowledge 
the possibility that patients also could find 
frequent observation of blood pressures and 
tighter parameters to be burdensome or 
increase anxiety about health status.   
While postpartum patient-reported outcome measures have been developed and validated to study inpatient 
recovery, lack of consensus exists regarding optimal measures of  outpatient recovery.95 In a recent systematic 
review of validated measures used to assess three domains or more of outpatient postpartum recovery, three 
measures were identified but all had significant limitations.96 The authors conclude that assessment may be 
better achieved using existing methods such as those endorsed by the Patient-Reported Outcomes 
Measurement Information System initiative (PROMIS).96 Therefore, we selected validated PROMIS and NIH 
Toolbox measures related to depression, anxiety, and social support. Because experience of being listened to 
or being ignored and dismissed are central drivers of Black women’s pregnancy and postpartum experience 
and health outcomes,38,39 we emphasize outcomes related to communication during and satisfaction with 
clinical encounters such as the Communication Assessment Tool -Team (CAT-T) and the Mothers on Respect 
Table 3: Study outcomes and time frame for assessment
Hypertension Outcomes
Blood pressure control
(Primary Outcome)
Mean SBP assessed in-office and through all 
methods
7-10 
days
Blood pressure control
(Primary Outcome)
Mean DBP assessed in-office and through all 
methods
7-10 
days
Severe hypertension
(Primary Outcome)
SBP >160 or DBP >110 on two occasions 15 
minutes apart and less than 4 hours apart 
6 weeks
Hospital readmission
Readmission for hypertension management after 
delivery discharge 
3 weeks
Severe maternal 
morbidity
Center for Disease Control criteria
6 weeks
Health Care Utilization
Blood pressure 
assessment
Proportion who report at least one BP reading  
post delivery
7-10 
days
Medication use
Proportion requiring and/or initiating 
antihypertensive medications
6 weeks
Urgent care visit
Visit to obstetric triage or an emergency 
department for hypertension
3 weeks
Postpartum visit 
attendance
Visit with an obstetric clinician postpartum 
(excludes acute care visit)
6 weeks
Primary care visit
Visit with a primary care clinician 
(excludes acute care visit)
12 week
Patient-Reported Outcome Measures
Satisfaction
How satisfied have you been with your 
postpartum care since discharge? (1-10)
6 weeks
Remote BP monitoring 
satisfaction
Overall, I am satisfied with my experience with 
remote blood pressure monitoring 
6 weeks
Feeling voice is heard
Overall, my questions and concerns have been 
listened to  since delivery 
6 weeks
Mothers on Respect 
index (MORi)
Assessment of respectful patient-provider 
interactions and their impact on a person’s 
sense of comfort, behavior, and perceptions of 
racism or discrimination
6 weeks
PROMIS Emotional 
Support
16 questions regarding availability to talk to 
others and feel appreciated by others
6 weeks
PROMIS Self-Efficacy
4 questions about perceived ability to manage 
difficult or unexpected events
6 weeks
PROMIS depression
Computer adaptive test measuring depression 
symptoms
6 weeks
Communication 
Assessment Tool (CAT)
15 questions measuring patient perceptions of 
clinician interpersonal and communication skills
6 & 15 
weeks
SBP=systolic blood pressure | DBP=diastolic blood pressure

 
 
index (MORi), a scale developed to assess the nature of respectful patient-provider interactions and their 
impact on a person’s sense of comfort, behavior, and perceptions of racism or discrimination.  
ENROLLMENT AND FEASIBILITY 
During 2021, 22% (n=1120) of patients 
delivering at VUMC had a diagnosis of HDP, 
most commonly gestational hypertension, 
preeclampsia, and chronic hypertension and 
22% of these patients were Black. We have 
used the eligibility, enrollment, and follow up 
estimates in Table 5 With an aim for 50% of 
our participants to self-identify as Black, we 
estimate that we can enroll a total sample 
size of 1000 patients with 6-week follow data 
after 4-years. Enrollment and follow up 
estimates are based on prior observational 
and intervention studies performed among 
postpartum patients.100–102 
 
ANALYTIC APPROACH 
Specific Aim 1: To assess whether augmented remote blood pressure monitoring and tight blood pressure 
control, both individually and in combination, improve blood pressure control and the frequency of severe 
hypertension in the first 2 weeks postpartum. 
 
Aim 1 Analytic Approach: Our primary analysis will examine the independent effect of the interventions 
(blood pressure goals and monitoring approach) on the primary outcomes. While randomized trials greatly 
reduce confounding, they do not eliminate it, and covariate adjustment enhances statistical power. Balance in 
participant’s demographic and clinical characteristics across the four groups (control + 3 interventions) will be 
compared using the Mann-Whitney U test for continuous variables and Chi squared test for categorical 
variables. Characteristics that exhibit differences across groups and potential confounding variables such as 
race, socioeconomic status, and medical comorbidities will be considered as adjusting covariates in the 
subsequent regression analysis. Multiple linear regression with ordinary least square estimates (OLS) will be 
used to compare the SBP and DBP primary outcomes across four interventions with a binary variable for the 
monitoring intervention (standard vs augmented), a binary variable for the blood pressure goal intervention 
(standard 150/100 and tight 140/90) and an interaction term between the two binary variables for the combined 
interventions. A negative value for two main effects of interventions indicates better blood pressure control 
using individual interventions alone than the standard of care. A negative value for the interaction effect 
indicates better blood pressure control using combined intervention than individual intervention alone. Post hoc 
analysis of variance (ANOVA) can be conducted to assess the overall effect of each individual interventions 
(with 2 degree of freedom) and the overall intervention effects (with 3 degree of freedom). Although OLS does 
not require normality assumption for outcomes and residuals, extreme outliers might result in potential bias. In 
this case, a non-parametric model (e.g. proportional odds model) will be considered. This analysis will be 
repeated allowing the primary outcome to include mean blood pressures reported via augmented remote 
monitoring among women who do not attend in-office visits. Multiple logistic regression will be conducted for 
binary outcomes including the severe hypertension primary outcome, hypertension secondary outcomes and 
healthcare utilization secondary outcomes. The same main effects and interaction effects for interventions 
specified for the linear regression model will be included with negative values for the log-odds ratio indicating 
improved outcomes in the intervention groups. Linear regression with OLS will be used for patient-reported 
secondary outcome measures in a similar fashion as SBP and DBP primary outcomes. Given the prospective 
design and dedicated personnel, we anticipate little missing covariate data. In case there are more than 1% 
participants with missing data in the analysis, multiple imputation will be conducted as sensitivity analysis. All 
outcomes will be analyzed as intent-to-treat.  
 
Specific Aim 2: To test whether these interventions narrow the existing Black/non-Black inequity in postpartum 
outcomes such as blood pressure control and severe hypertension. 

 
 
 
Aim 2 Analytic Approach: Given 
racial disparities in postpartum 
outcomes and hypothesized 
heterogeneity of intervention effect, we 
plan for two pre-specified subgroup 
analysis in (1) standard care only 
(N=250) (2) Black participants only 
(N=500). The first subgroup analysis 
aims to assess racial disparities in 
postpartum outcomes without 
intervention where Black/non-Black 
will be the main effect of interests. The 
second subgroup analysis aims to 
reassess intervention effects observed 
in Aim 1 but within Black participants. 
To test the hypothesis of the 
interventions narrowing racial inequity, 
we will use the overall cohort (N=1000) and additionally include the interaction between Black/Non-Black and 
the intervention effects (two main effects + one interaction effects) on top of all models in Aim 1. Missing data 
will be handled in the similar fashion as Aim 1. Power and Sample Size Considerations (All Aims): For Aim 
1, power consideration is conducted in the setting of two group comparisons with sample size of N=250 (N=75 
for Aim 3) in the standard care group and N=500 (N=150 for Aim 3) for each individual intervention instead of 
in the setting of 2x2 factorial design with N=1000 (N=300 for Aim 3) because the effect size of F-statistics for 
continuous outcomes and chi-square statistics for binary outcomes is not clinically interpretable. Review of 
institutional data found that 10.2% of patients with HDP at delivery experience sustained severe hypertension 
within the first 6 weeks postpartum and these patients have a mean SBP of 138 (SD 17.2) and mean DBP of 
83 (SD 11.9). We will have 80% power to detect a minimum of 0.22 standardized reduction in SBP and DBP (a 
small effect by Cohen’s nomenclature103) which corresponds to reduction in SBP from 138 to 134 mmHg and 
DBP from 83 to 80 mmHg. Additionally, we will have 80% power to detect 57% reduction in sustained severe 
hypertension. Minimum detectable effect sizes for selected secondary outcomes in Aim 1 and the primary 
outcome for Aim 3 are provided (Table 6). For Aim 3, we will have 80% power to detect a minimum of 0.4 
standardized difference in cardiovascular outcomes (a medium effect by Cohen’s nomenclature), which 
corresponds to an increase of lateral e' from 11.7 to 13.1. For Aim 2, power justification is conducted based on 
N=300 using analysis of variance (ANOVA) for the interaction terms between race and interventions effects 
(with 3 degree of freedom) for the SBP and DBP primary outcomes. The minimum detectable F-statistics for 
the overall interaction term is 0.19 which is small-to-medium effect by Cohen’s nomenclature. The power 
consideration does not consider adjusting covariates and thus is conservative since inclusion of adjusting 
covariates will improve the power of the study. 
 
 

 
 
DATA AND SAFETY MONITORING 
Data will be entered directly into the Research Electronic Data Capture (REDCap) site, a secure web platform 
for building and managing online databases and surveys with flexible design of electronic CRFs. REDCap is 
compliant with the Health Insurance Portability and Accountability Act and includes password protection. 
REDCap maintains records of all changes made to databases so that investigators can identify deleted data 
and changes made. Each person accessing REDCap has an individual ID for security tracking and to prevent 
unauthorized access to data. Data can be exported to common statistical analysis packages (e.g., SAS, R, and 
Stata) and protected health information removed. Several internal quality checks are available in REDCap 
including: automatic range checks for numeric variables and creation of automatic data reports that help 
identify data that appears inconsistent, incomplete, or inaccurate. Every two weeks, a separate clinical trials 
associate assigned to support the study will audit 3 randomly selected charts to ensure that data have been 
entered correctly and for continuous process improvement. After obtaining informed consent, a copy of the 
consent form will be sent to participants via email or text and all information retained in the REDCap database. 
The REDCap database is encrypted and can only be accessed by research personnel with appropriate 
clearance. 
 
For this study, an adverse event (AE) is defined as any untoward medical occurrence associated with the 
study, whether or not considered intervention- or procedure-related. An AE can therefore be any undesirable or 
unintended sign, symptom, laboratory testing or diagnostic imaging finding, or disease temporally associated 
with participation in the study, without any judgement about causality. The determination of the relationship 
between the AE and the study procedures must be made by the PI or their designee. This definition will also 
include changes in the participant medical status that may be related to the study procedures. Maternal 
medical conditions that are present prior to consent can be considered as baseline and not reported as AEs. 
However, if the participant's condition deteriorates at any time during the study, it will be recorded as an AE.  
 
The PI will monitor protocol adherence and the progress of the trial on an ongoing basis by reviewing all data 
collected and monitoring enrollment and follow up. For participants who indicate a high degree of 
dissatisfaction with the study, the PI will contact the participant to assess the source of the dissatisfaction and 
whether any postpartum complications have arisen. If complications are uncovered and the participant requires 
medical care, we will facilitate obtaining care with our providers at Vanderbilt. The PI will notify the Vanderbilt 
University's Institutional Review Board (IRB) of any AEs promptly and at most within 7 days of the event. If the 
adverse event is thought to be due to the study, the PI will draft a safety report and send a copy to the IRB who 
serves as an objective review mechanism.  This policy/procedure means that any potential conflict of interest 
inherent in the PI being the sole reviewer of serious adverse advents is avoided. In addition, all research 
personnel will be asked to contact the PI within 24 hours to report serious adverse advents. All SAEs occur 
during the study defined by the given protocol, regardless of the relation to the research, will be reported to the 
IRB by telephone, e-mail or fax within 24 hours of the investigator's awareness of the occurrence of the event. 
All expected non-serious adverse events (i.e. patient dissatisfaction) that occur at a greater frequency or 
severity than anticipated and all unexpected non-serious adverse events will be reported to the IRB within 15 
working days of the investigator becoming aware of the event. Adverse events will be summarized annually in 
the IRB application for continuation or termination of the research. 

 
 
APPENDIX A 
 
Blood pressure cuff fitting 
 
Arm circumference to be measured and recorded in REDCap along with size of cuff provided 
1. AC 17-22cm: small size cuff  
2. AC 23-42cm: wide range size cuff  
3. AC 43-50cm: extra large adult size cuff 
 

 
 
APPENDIX B: Epic MyHealth Message for Intervention #1 (Standard Control / In-Office Monitoring) 
 
Dear Ms. [last name], 
 
Thank you for being part of the Vanderbilt Fourth Trimester (V4) study. The V4 study will help us learn how to 
better care for women with high blood pressure in pregnancy. 
 
You have been assigned to the following interventions: 
 
1. Blood pressure goal: <150/100  
From discharge through 6 weeks postpartum, we recommend that your blood pressure be less than 150 
mmHg systolic (top number) and less than 100 mmHg diastolic (bottom number). If either the top or the 
bottom blood pressure is higher than the target, your obstetric provider may consider starting or changing 
medications.  
 
2. Blood pressure monitoring: Obstetric Provider 
- 
You will be given an appointment to have your blood pressure checked in the office within 10 days of 
delivery. Usually you receive a MyHealth message about the appointment. 
- 
For the first 2 weeks after delivery, you should check your blood pressure twice a day 
- 
For weeks 3 to 6, you should check your blood pressure once a day 
- 
If your blood pressures are over the goal above, contact your obstetric provider 
 
3. Preeclampsia Danger Signs 
Seek medical attention within an hour if you have any of the following: 
- 
Blood pressure of 160 mmHg systolic (top number) or 110 mmHg diastolic (bottom number) after two 
blood pressure checks at least 15 minutes or more apart and within 4 hours  
- 
A persistent headache that does not go away with rest, eating, or Tylenol 
- 
Spots in your vision or difficulty seeing 
- 
Difficulty breathing 
- 
Persistent and worsening pain in your belly especially in the mid-upper or right-upper areas  
 
4. Long-term Care 
High blood pressure in pregnancy often goes away after delivery, but in some people it stays. Even if it 
goes away, having high blood pressure in pregnancy can make you higher risk for high blood pressure or 
heart disease later in life. You should see a primary care provider or cardiologist within 3 months after 
delivery to discuss ways to improve your heart health and to monitor your blood pressure. Be sure to tell 
your provider that you had high blood pressure in pregnancy. 
 
Instructions for checking your blood pressure 
1. Wait at least 30 minutes after smoking, eating, drinking caffeine (coffee, tea, soda), or exercising. 
2. Sit comfortably at a table with both feet on the floor and your arm resting on the table, palm up. 
3. Wrap the cuff around your arm, just above your elbow and not over clothing.  
4. Push the button to inflate the cuff and record the blood pressure reading. 
5. If the reading is above your goal blood pressure, wait 15 minutes and recheck it 
 
If you have any questions or concerns about the study, please contact Dr. Alexandra Phelps at 
alexandra.j.phelps@vumc.org 

 
 
APPENDIX C: Epic MyHealth Message for Intervention #2 (Tight Control / OB Provider Monitoring) 
 
Dear Ms. [last name], 
 
Thank you for being part of the Vanderbilt Fourth Trimester (V4) study. The V4 study will help us learn how to 
better care for women with high blood pressure in pregnancy. 
 
You have been assigned to the following interventions: 
 
1. Blood pressure goal: <140/90  
From discharge through 6 weeks postpartum, we recommend that your blood pressure be less than 140 
mmHg systolic (top number) and less than 90 mmHg diastolic (bottom number). If either the top or the 
bottom blood pressure is higher than the target, your obstetric provider may consider starting medications 
or changing your dose of medication.  
 
2. Blood pressure monitoring: Obstetric Provider 
- 
You will be given an appointment to have your blood pressure checked in the office within 10 days of 
delivery. Usually, you receive a MyHealth message about the appointment. 
- 
For the first 2 weeks after delivery, you should check your blood pressure twice a day 
- 
For weeks 3 to 6, you should check your blood pressure once a day 
- 
If your blood pressures are over the goal above, contact your obstetric provider 
 
3. Preeclampsia Danger Signs 
Seek medical attention within an hour if you have any of the following: 
- 
Blood pressure of 160 mmHg systolic (top number) or 110 mmHg diastolic (bottom number) after two 
blood pressure checks at least 15 minutes or more apart and within 4 hours  
- 
A persistent headache that does not go away with rest, eating, or Tylenol 
- 
Spots in your vision or difficulty seeing 
- 
Difficulty breathing 
- 
Persistent and worsening pain in your belly especially in the mid-upper or right-upper areas  
 
4. Long-term Care 
High blood pressure in pregnancy often goes away after delivery, but in some people it stays. Even if it 
goes away, having high blood pressure in pregnancy can make you higher risk for high blood pressure or 
heart disease later in life. You should see a primary care provider or cardiologist within 3 months after 
delivery to discuss ways to improve your heart health and to monitor your blood pressure. Be sure to tell 
your provider that you had high blood pressure in pregnancy. 
 
Instructions for checking your blood pressure 
1. Wait at least 30 minutes after smoking, eating, drinking caffeine (coffee, tea, soda), or exercising. 
2. Sit comfortably at a table with both feet on the floor and your arm resting on the table, palm up. 
3. Wrap the cuff around your arm, just above your elbow and not over clothing.  
4. Push the button to inflate the cuff and record the blood pressure reading. 
5. If the reading is above your goal blood pressure, wait 15 minutes and recheck it 
 
If you have any questions or concerns about the study, please contact Dr. Alexandra Phelps at 
alexandra.j.phelps@vumc.org 

 
 
APPENDIX D: Epic MyHealth Message for Intervention #3 (Standard Control / Augmented Remote Blood 
Pressure Monitoring) 
 
Dear Ms. [last name], 
 
Thank you for being part of the Vanderbilt Fourth Trimester (V4) study. The V4 study will help us learn how to 
better care for women with high blood pressure in pregnancy. 
 
You have been assigned to the following interventions: 
 
1. Blood pressure goal: <150/100  
From discharge through 6 weeks postpartum, we recommend that your blood pressure be less than 150 
mmHg systolic (top number) and less than 100 mmHg diastolic (bottom number). If either the top or the 
bottom blood pressure is higher than target, your obstetric provider may start or change medications.  
 
2. Blood pressure monitoring: Remote Blood Pressure Monitoring 
- 
Our Hypertension Nurse Navigator [Name] will be the primary contact for all issues related to blood 
pressure until 6 weeks after delivery. She will contact you through MyHealth. 
- 
You will be given an appointment to have your blood pressure checked in the office within 10 days of 
delivery. Usually, you receive a MyHealth message about the appointment. 
- 
For the first 2 weeks after delivery, you should check your blood pressure twice a day. Record your 
blood pressures every day in the Track My Health feature on your MyHealth app. The Hypertension 
Nurse Navigator will contact you every weekday to comment on your blood pressures. 
- 
For weeks 3 to 6, you should check your blood pressure once a day unless otherwise instructed. 
Record your blood pressures every day in the Track My Health feature on your MyHealth app. The 
Hypertension Nurse Navigator will contact you at least weekly to comment on your blood pressures. 
- 
If your blood pressures are over the goal above, you may be recommended to start medications or 
change your dose of medication 
- 
The Hypertension Nurse Navigator will update your obstetric provider on your blood pressure 
management 
 
3. Preeclampsia Danger Signs 
Seek medical attention within an hour if you have any of the following: 
- 
Blood pressure of 160 mmHg systolic (top number) or 110 mmHg diastolic (bottom number) after two 
blood pressure checks at least 15 minutes or more apart and within 4 hours  
- 
A persistent headache that does not go away with rest, eating, or Tylenol 
- 
Spots in your vision or difficulty seeing 
- 
Difficulty breathing 
- 
Persistent and worsening pain in your belly especially in the mid-upper or right-upper areas  
 
4. Long-term Care 
High blood pressure in pregnancy often goes away after delivery, but in some people it stays. Even if it 
goes away, having high blood pressure in pregnancy can make you higher risk for high blood pressure or 
heart disease later in life. You should see a primary care provider or cardiologist within 3 months after 
delivery to discuss ways to improve your heart health and to monitor your blood pressure. Be sure to tell 
your provider that you had high blood pressure in pregnancy 
 
Instructions for checking your blood pressure 
1. Wait at least 30 minutes after smoking, eating, drinking caffeine (coffee, tea, soda), or exercising. 
2. Sit comfortably at a table with both feet on the floor and your arm resting on the table, palm up. 
3. Wrap the cuff around your arm, just above your elbow and not over clothing.  
4. Push the button to inflate the cuff and record the blood pressure reading. 
5. If the reading is above your goal blood pressure, wait 15 minutes and recheck it 
 
If you have any questions or concerns about the study, please contact Dr. Alexandra Phelps at 
alexandra.j.phelps@vumc.org 

 
 
APPENDIX E: Epic MyHealth Message for Intervention #4 (Tight Control / Augmented Remote Blood 
Pressure Monitoring) 
 
Dear Ms. [last name], 
 
Thank you for being part of the Vanderbilt Fourth Trimester (V4) study. The V4 study will help us learn how to 
better care for women with high blood pressure in pregnancy. 
 
You have been assigned to the following interventions: 
 
1. Blood pressure goal: <140/90  
From discharge through 6 weeks postpartum, we recommend that your blood pressure be less than 140 
mmHg systolic (top number) and less than 90 mmHg diastolic (bottom number). If either the top or the 
bottom blood pressure is higher than the target, your obstetric provider may start or change medications.  
 
2. Blood pressure monitoring: Remote Blood Pressure Monitoring 
- 
Our Hypertension Nurse Navigator [Name] will be the primary contact for all issues related to blood 
pressure until 6 weeks after delivery. She will contact you through MyHealth. 
- 
You will be given an appointment to have your blood pressure checked in the office within 10 days from 
delivery. Usually, you receive a MyHealth message about the appointment. 
- 
For the first 2 weeks after delivery, you should check your blood pressure twice a day. Record your 
blood pressures every day in the Track My Health feature on your MyHealth app. The Hypertension 
Nurse Navigator will contact you every weekday to comment on your blood pressures. 
- 
For weeks 3 to 6, you should check your blood pressure once a day unless otherwise instructed. 
Record your blood pressures every day in the Track My Health feature on your MyHealth app. The 
Hypertension Nurse Navigator will contact you at least weekly to comment on your blood pressures. 
- 
If your blood pressures are over the goal above, you may be recommended to start medications or 
change your dose 
- 
The Hypertension Nurse Navigator will update your obstetric provider on your blood pressure 
management 
 
3. Preeclampsia Danger Signs 
Seek medical attention within an hour if you have any of the following: 
- 
Blood pressure of 160 mmHg systolic (top number) or 110 mmHg diastolic (bottom number) after two 
blood pressure checks at least 15 minutes or more apart and within 4 hours  
- 
A persistent headache that does not go away with rest, eating, or Tylenol 
- 
Spots in your vision or difficulty seeing 
- 
Difficulty breathing 
- 
Persistent and worsening pain in your belly especially in the mid-upper or right-upper areas  
 
4. Long-term Care 
High blood pressure in pregnancy often goes away after delivery, but in some people it stays. Even if it 
goes away, having high blood pressure in pregnancy can make you higher risk for high blood pressure or 
heart disease later in life. You should see a primary care provider or cardiologist within 3 months after 
delivery to discuss ways to improve your heart health and to monitor your blood pressure. Be sure to tell 
your provider that you had high blood pressure in pregnancy 
 
Instructions for checking your blood pressure 
1. Wait at least 30 minutes after smoking, eating, drinking caffeine (coffee, tea, soda), or exercising. 
2. Sit comfortably at a table with both feet on the floor and your arm resting on the table, palm up. 
3. Wrap the cuff around your arm, just above your elbow and not over clothing.  
4. Push the button to inflate the cuff and record the blood pressure reading. 
5. If the reading is above your goal blood pressure, wait 15 minutes and recheck it 
 
If you have any questions or concerns about the study, please contact Dr. Alexandra Phelps at 
alexandra.j.phelps@vumc.org 

 
 
APPENDIX F: Message to Obstetric Providers Intervention #1 (Standard Control / OB Provider Monitoring) 
 
Dear [provider’s name and salutation], 
 
Your patient, [patient’s name], recently delivered and her pregnancy was complicated by a hypertensive 
disorder of pregnancy. She is participating in the Vanderbilt Fourth Trimester (V4) Study, which is a 
randomized controlled trial examining different blood pressure targets and management styles for postpartum 
hypertension.   
 
Ms. [patient last name] has been assigned to the standard blood pressure control group in line with current 
recommendations from ACOG. Her target blood pressure is <150 mmHg systolic and <100 mmHg diastolic.   
 
As part of the study, your patient will: 
• 
Receive a blood pressure cuff and be taught how to use it properly 
• 
Be scheduled for an in-person blood pressure check within 10 days of delivery 
• 
Be instructed to check blood pressures twice daily for weeks 1-2 after delivery and daily for weeks 3-6 
• 
Contact you if she has blood pressures consistently above this target 
• 
Be advised of preeclampsia danger signs and symptoms 
• 
See you for routine postpartum needs including a postpartum visit 
• 
Be instructed to see a primary care provider or cardiologist within 3 months of delivery 
 
We sincerely appreciate your support for this study. If you have any questions or concerns, please do not 
hesitate to contact Dr. Alexandra Phelps at alexandra.j.phelps@vumc.org. 
 
Sincerely, 
 
Sarah Osmundson, MD, MS (Primary Investigator) 
Maternal-Fetal Medicine 
 
Alexandra Phelps, MD (Co-Primary Investigator) 
Maternal-Fetal Medicine Fellow 

 
 
APPENDIX G: Message to Obstetric Providers Intervention #2 (Tight Control / OB Provider Monitoring) 
 
Dear [provider’s name and salutation], 
 
Your patient, [patient’s name], recently delivered and her pregnancy was complicated by a hypertensive 
disorder of pregnancy. She is participating in the Vanderbilt Fourth Trimester (V4) Study, which is a 
randomized controlled trial examining different blood pressure targets and management styles for postpartum 
hypertension.   
 
Ms. [patient last name] has been assigned to the tight blood pressure control group. Her target blood pressure 
is <140 mmHg systolic and <90 mmHg diastolic. We recommend initiating or titrating medications to 
maintain blood pressures less than 140/90. 
 
As part of the study, your patient will: 
• 
Receive a blood pressure cuff and be taught how to use it properly 
• 
Be scheduled for an in-person blood pressure check within 10 days of delivery 
• 
Be instructed to check blood pressures twice daily for weeks 1-2 after delivery and daily for weeks 3-6 
• 
Contact you if she has blood pressures consistently above this target 
• 
Be advised of preeclampsia danger signs and symptoms 
• 
See you for routine postpartum needs including a postpartum visit 
• 
Be instructed to see a primary care provider or cardiologist within 3 months of delivery 
 
We sincerely appreciate your support for this study. If you have any questions or concerns, please do not 
hesitate to contact Dr. Alexandra Phelps at alexandra.j.phelps@vumc.org. 
 
Sincerely, 
 
Sarah Osmundson, MD, MS (Primary Investigator) 
Maternal-Fetal Medicine 
 
Alexandra Phelps, MD (Co-Primary Investigator) 
Maternal-Fetal Medicine Fellow 
 

 
 
APPENDIX H: Message to Obstetric Providers Intervention #3 (Standard Control / Augmented Remote Blood 
Pressure Monitoring) 
 
Dear [provider’s name and salutation], 
 
Your patient, [patient’s name], recently delivered and her pregnancy was complicated by a hypertensive 
disorder of pregnancy. She is participating in the Vanderbilt Fourth Trimester (V4) Study, which is a 
randomized controlled trial examining different blood pressure targets and management styles for postpartum 
hypertension.   
 
Ms. [patient last name] has been assigned to the standard blood pressure control group in line with current 
recommendations from ACOG. Her target blood pressure is <150 mmHg systolic and <100 mmHg diastolic.   
 
As part of the study, your patient will: 
• 
Receive a blood pressure cuff and be taught how to use it properly 
• 
Be scheduled for an in-person blood pressure check within 10 days of delivery 
• 
Record blood pressures and send them to the study Hypertension Nurse Manager 
• 
Have all hypertension related issues including blood pressure medications managed by the study 
Hypertension Nurse Manager in collaboration with Maternal-Fetal Medicine.  
• 
Be advised of preeclampsia danger signs and symptoms 
• 
See you for routine postpartum needs including a postpartum visit 
• 
See a primary care provider or cardiologist within 3 months of delivery 
 
The Hypertension Nurse Manager will send you periodic updates on your patient’s hypertension progress. 
 
We sincerely appreciate your support for this study. If you have any questions or concerns, please do not 
hesitate to contact Dr. Alexandra Phelps at alexandra.j.phelps@vumc.org. 
 
Sincerely, 
 
Sarah Osmundson, MD, MS (Primary Investigator) 
Maternal-Fetal Medicine 
 
Alexandra Phelps, MD (Co-Primary Investigator) 
Maternal-Fetal Medicine Fellow 
 

 
 
APPENDIX I: Message to Obstetric Providers Intervention #4 (Tight Control / Augmented Remote Blood 
Pressure Monitoring) 
 
Dear [provider’s name and salutation], 
 
Your patient, [patient’s name], recently delivered and her pregnancy was complicated by a hypertensive 
disorder of pregnancy. She is participating in the Vanderbilt Fourth Trimester (V4) Study, which is a 
randomized controlled trial examining different blood pressure targets and management styles for postpartum 
hypertension.   
 
Ms. [patient last name] has been assigned to the tight blood pressure control group. Her target blood pressure 
is <140 mmHg systolic and <90 mmHg diastolic.   
 
As part of the study, your patient will: 
• 
Receive a blood pressure cuff and be taught how to use it properly 
• 
Be scheduled for an in-person blood pressure check within 10 days of delivery 
• 
Record blood pressures and send them to the study Hypertension Nurse Manager 
• 
Have all hypertension related issues including blood pressure medications managed by the study 
Hypertension Nurse Manager in collaboration with Maternal Fetal Medicine.  
• 
Be advised of preeclampsia danger signs and symptoms 
• 
See you for routine postpartum needs including a postpartum visit 
• 
See a primary care provider or cardiologist within 3 months of delivery 
 
The Hypertension Nurse Manager will send you periodic updates on your patient’s hypertension progress. 
 
We sincerely appreciate your support for this study. If you have any questions or concerns, please do not 
hesitate to contact Dr. Alexandra Phelps at alexandra.j.phelps@vumc.org. 
 
Sincerely, 
 
Sarah Osmundson, MD, MS (Primary Investigator) 
Maternal-Fetal Medicine 
 
Alexandra Phelps, MD (Co-Primary Investigator) 
Maternal-Fetal Medicine Fellow 
 
 

 
 
APPENDIX J 
 
STANDARD blood pressure control treatment algorithm: 
 
 

 
 
APPENDIX K 
 
TIGHT blood pressure control treatment algorithm: 
 
 
 
 

 
 
APPENDIX L 
 

 
 
 
 
REFERENCES 
 
1. Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and 
postpartum readmission in the United States. J Hypertens. 2018;36(3):608-618. 
doi:10.1097/hjh.0000000000001594 
2. Control C for D. Pregnancy Mortality Surveillance System | Maternal and Infant Health | CDC.pdf. Published 
November 25, 2020. Accessed February 22, 2022. https://www.cdc.gov/reproductivehealth/maternal-
mortality/pregnancy-mortality-surveillance-system.htm 
3. Obstetric Care Consensus No. 5: Severe Maternal Morbidity: Screening and Review. Obstetrics Gynecol. 
2016;128(3):e54-e60. doi:10.1097/aog.0000000000001642 
4. Hitti J, Sienas L, Walker S, Benedetti TJ, Easterling T. Contribution of hypertension to severe maternal 
morbidity. Am J Obstet Gynecol. 2018;219(4):405.e1-405.e7. doi:10.1016/j.ajog.2018.07.002 
5. Bateman BT, Shaw KM, Kuklina EV, Callaghan WM, Seely EW, Hernández-Díaz S. Hypertension in Women 
of Reproductive Age in the United States: NHANES 1999-2008. Plos One. 2012;7(4):e36171. 
doi:10.1371/journal.pone.0036171 
6. Stamilio DM, Beckham AJ, Boggess KA, Jelovsek JE, Venkatesh KK. Risk factors for postpartum 
readmission for preeclampsia or hypertension before delivery discharge among low-risk women: a case-control 
study. Am J Obstetrics Gynecol Mfm. 2021;3(3):100317. doi:10.1016/j.ajogmf.2021.100317 
7. Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed Postpartum 
Preeclampsia and Eclampsia. Obstetrics Gynecol. 2011;118(5):1102-1107. 
doi:10.1097/aog.0b013e318231934c 
8. Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-Related Mortality in the United States, 2011–
2013. Obstetrics Gynecol. 2017;130(2):366-373. doi:10.1097/aog.0000000000002114 
9. Gyamfi-Bannerman C, Pandita A, Miller EC, et al. Preeclampsia outcomes at delivery and race. J Maternal-
fetal Neonatal Medicine. 2019;33(21):3619-3626. doi:10.1080/14767058.2019.1581522 
10. Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the 
United States. Am J Obstet Gynecol. 2016;215(1):113.e1-113.e10. doi:10.1016/j.ajog.2016.01.174 
11. Optimizing Postpartum Care. ACOG Committee Opinion No. 736. Obstetrics Gynecol. 2018;131(5):e140-
e150. doi:10.1097/aog.0000000000002633 
12. Shih T, Peneva D, Xu X, et al. The Rising Burden of Preeclampsia in the United States Impacts Both 
Maternal and Child Health. Am J Perinat. 2015;33(04):329-338. doi:10.1055/s-0035-1564881 
13. Wu P, Haththotuwa R, Kwok CS, et al. Preeclampsia and Future Cardiovascular Health. Circulation 
Cardiovasc Qual Outcomes. 2018;10(2):e003497. doi:10.1161/circoutcomes.116.003497 
14. Tenn. Notice of Change to the TennCare III Program Maternal Health Enhancements. Accessed March 3, 
2022. 
https://www.tn.gov/content/dam/tn/tenncare/documents2/ChangeTennCareIIIProgramMaternalHealthEnhance
ments.pdf 

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.
2018;27(11):871. doi:10.1136/bmjqs-2018-007837
16. Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial disparities in
postpartum blood pressure ascertainment. Am J Obstet Gynecol. 2019;221(3):283-285.
doi:10.1016/j.ajog.2019.05.011
17. Hauspurg A, Lemon LS, Quinn BA, et al. A Postpartum Remote Hypertension Monitoring Protocol
Implemented at the Hospital Level. Obstetrics Gynecol. 2019;134(4):685-691.
doi:10.1097/aog.0000000000003479
18. Yee LM, Martinez NG, Nguyen AT, Hajjar N, Chen MJ, Simon MA. Using a Patient Navigator to Improve
Postpartum Care in an Urban Women’s Health Clinic. Obstetrics Gynecol. 2017;129(5):925-933.
doi:10.1097/aog.0000000000001977
19. Celi AC, Seely EW, Wang P, Thomas AM, Wilkins-Haug LE. Caring for Women After Hypertensive
Pregnancies and Beyond: Implementation and Integration of a Postpartum Transition Clinic. Matern Child Healt
J. 2019;23(11):1459-1466. doi:10.1007/s10995-019-02768-7
20. Suresh SC, Duncan C, Kaur H, et al. Postpartum Outcomes With Systematic Treatment and Management
of Postpartum Hypertension. Obstetrics Gynecol. 2021;138(5):777-787. doi:10.1097/aog.0000000000004574
21. Joosten YA, Israel TL, Williams NA, et al. Community Engagement Studios: A Structured Approach to
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22. Janevic T, Maru S, Nowlin S, et al. Pandemic Birthing: Childbirth Satisfaction, Perceived Health Care Bias,
and Postpartum Health During the COVID-19 Pandemic. Matern Child Healt J. 2021;25(6):860-869.
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509.

VUMC Institutional Review Board 
Informed Consent Document for Research
Study Title:
Version Date:
PI:
Comprehensive Postpartum Management for Women with Hypertensive 
Disorders of Pregnancy: a Randomized Controlled Trial 
4/4/2023
Sarah Osmundson, MD, MS 
1
This box is for
IRB USE ONLY
Do not edit or delete
Name of participant: __________________________________________ Age: ___________ 
The following is given to you to tell you about this research study.  Please read this form 
with care and ask any questions you may have about this study.  Your questions will be 
answered.  Also, you will be given a copy of this consent form. 
Key information about this study:  
The purpose of this study is to see if close monitoring of blood pressure postpartum by a 
dedicated team and using lower blood pressure goals improves blood pressure outcomes. You 
will randomly be assigned to one of four treatment groups and receive a blood pressure cuff to 
monitor blood pressures at home. You will be asked to complete three 15-minute surveys during 
the 3 months after giving birth. You may be asked to communicate with a study member about 
your blood pressure and aim for lower blood pressure during the study period. 
You are being asked to take part in this research study because you had high blood pressure 
during pregnancy and/or postpartum.  
You do not have to be in this research study. You may choose not to be in this study and get 
other treatments without changing your healthcare, services, or other rights.  You can stop 
being in this study at any time.  If we learn something new that may affect the risks or benefits of 
this study, you will be told so that you can decide whether or not you still want to be in this 
study. Your medical record will contain a note saying you are in a research study and may 
contain some research information about you.  Anyone you authorize to receive your medical 
record will also get this information. 
Side effects and risks that you can expect if you take part in this study:  
Risks from participating in the study are minimal but could include accidental disclosure of 
personal health information. Other risks could include over-treating or over-managing blood 
pressure without added health benefits. 
Good effects that might result from this study:
By taking part in this study, you may receive more attention and assistance managing your 
blood pressures and have positive feelings from contributing to science. This study may help us 
better care for women with high blood pressure after pregnancy, reduce complications, and 
improve long-term health outcomes.  
Key Information: 
The first section of this document contains some key points that the research team thought 
you would find important. The study is described in more detail after this section. If you do 
not understand something, please ask someone. 
Detailed Information:
The rest of this document includes detailed information about this study (in addition to the 
information listed above).
Date of IRB Approval: 4/4/2023
D

VUMC Institutional Review Board 
Informed Consent Document for Research
Study Title:
Version Date:
PI:
2
This box is for
IRB USE ONLY
Do not edit or delete
Procedures to be followed: 
You will receive a blood pressure cuff and be assigned to 1 of 4 treatment groups: 
1) Blood Pressure Management by your OB Provider and Standard Blood Pressure Goals
You will be asked to check your blood pressure twice a day for the first two weeks and
report elevated blood pressures to your obstetric provider. Your goal blood pressure will be
less than 150 systolic and less than 100 diastolic.
2) Blood Pressure Management by your OB Provider and Lower Blood Pressure Goals
You will be asked to check your blood pressure twice a day for the first two weeks and
report elevated blood pressures to your obstetric provider. Your goal blood pressure will be
less than 140 systolic and less than 90 diastolic.
3) Blood Pressure Management by a Study Nurse and Standard Blood Pressure Goals
You will be asked to check your blood pressure twice a day for the first two weeks and
report elevated blood pressures daily through MyHealth to the Study Nurse. Your goal blood
pressure will be less than 150 systolic and less than 100 diastolic.
4) Blood Pressure Management by a Study Nurse and Lower Blood Pressure Goals
You will be asked to check your blood pressure twice a day for the first two weeks and
report elevated blood pressures daily through MyHealth to the Study Nurse. Your goal blood
pressure will be less than 140 systolic and less than 90 diastolic
In addition, you will be asked to complete 3 surveys: 1) In the hospital at the time you join the 
study (10minutes), 2) At 6 weeks postpartum (20 minutes), and 3) at 12 weeks postpartum (5 
minutes). You will not be asked to attend any additional visits outside of those routinely 
recommended for patients with high blood pressure during pregnancy. You may be asked to 
start medications to keep your blood pressure below the target goal. 
Payments for your time spent taking part in this study or expenses: 
You will receive $10 for completing the 1st survey in the hospital, $20 for completing a 2nd survey 
at 6 weeks postpartum, and $20 for completing a 3rd survey at 12 weeks postpartum, for a total 
of $50 if you complete the entire study. 
You are not allowed to accept any money for taking part in this study if you are not eligible to 
receive money from a U.S. person or company or the U.S. government because of U.S. national 
security and/or foreign policy laws.  You can still take part in the study however, you will not be 
paid if you are a resident of a country restricted by the U.S. government‘s comprehensive 
territorial sanctions or if you are listed on the U.S. Treasury Department’s Office of Foreign 
Assets Control’s Specially Designated Nationals (SDN) list of prohibited individuals.  You do not 
have to say why you choose not to be paid. 
Costs to you if you take part in this study: 
There is no cost to you for taking part in this study. 
Payment in case you are injured because of this research study:
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests 
or treatments that are done for research, then you and/or your insurance will not have to pay for the cost 
of immediate medical care provided at Vanderbilt to treat the injury.  
Date of IRB Approval: 04/4/2023
D
Comprehensive Postpartum Management for Women with Hypertensive 
Disorders of Pregnancy: a Randomized Controlled Trial 
4/4/2023
Sarah Osmundson, MD, MS 

VUMC Institutional Review Board 
Informed Consent Document for Research
Study Title:
Version Date:
PI:
3
This box is for
IRB USE ONLY
Do not edit or delete
There are no plans for Vanderbilt to pay for any injury caused by the usual care you would normally 
receive for treating your illness or the costs of any additional care. There are no plans for Vanderbilt to 
give you money for the injury. 
Who to call for any questions or in case you are injured: 
If you should have any questions about this research study or if you feel you have been hurt by 
being a part of this study, please feel free to contact Dr. Alexandra Phelps at 615-782-9849 or 
the Principal Investigator, Dr. Sarah Osmundson at 615-343-7869. If you cannot reach the 
research staff, please page the study doctor at 615-835-7969. 
For additional information about giving consent or your rights as a person in this study, to 
discuss problems, concerns, and questions, or to offer input, please feel free to call the VUMC 
Institutional Review Board Office at (615) 322-2918 or toll free at (866) 224-8273.
Reasons why the study doctor may take you out of this study:  
If you develop a condition that would require your blood pressure to be managed in a non-
routine way or if you cannot complete the surveys or use MyHealth for communicating, you may 
be taken out of the study.  
What will happen if you decide to stop being in this study? 
If you decide to stop being part of the study, you should tell your study doctor.  Deciding to not 
be part of the study will not change your regular medical care in any way. 
Clinical Trials Registry: 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law.  This website will not include information that can identify you.  At most, the website will 
include a summary of the results.  You can search this Web site at any time. 
Confidentiality:  
You will be assigned a study number and all study information will be collected under this 
number. All information will be held in a password-protected electronic file and any hardcopies 
will be kept in a locked file cabinet in the research office. All information published will be de-
identified and published as total study numbers.  
This study may have some support from the National Institutes of Health (NIH). If so, your study 
information is protected by a Certificate of Confidentiality. This Certificate allows us, in some 
cases, to refuse to give out your information even if requested using legal means.
It does not protect information that we have to report by law, such as child abuse or some 
infectious diseases.  The Certificate does not prevent us from disclosing your information if we 
learn of possible harm to yourself or others, or if you need medical help.
Disclosures that you consent to in this document are not protected. This includes putting 
research data in the medical record or sharing research data for this study or future 
research. Disclosures that you make yourself are also not protected.
Date of IRB Approval: 4/4/2023
D
Comprehensive Postpartum Management for Women with Hypertensive 
Disorders of Pregnancy: a Randomized Controlled Trial 
4/4/2023
Sarah Osmundson, MD, MS 

VUMC Institutional Review Board 
Informed Consent Document for Research
Study Title:
Version Date:
PI:
4
This box is for
IRB USE ONLY
Do not edit or delete
Privacy: 
Any samples and information about you may be made available to others to use for research.  To 
protect your privacy, we will not release your name.  You will not receive any benefit as a result 
of the tests done on your samples.  These tests may help us or other researchers learn more 
about the causes, risks, treatments, or how to prevent this and other health problems.  
Study Results: 
We will publish our study results, which makes them available to the public. If you would like a 
copy of the study results, please email Dr. Phelps at alexandra.j.phelps@vumc.org. 
Authorization to Use/Disclose Protected Health Information 
What information is being collected, used, or shared?
To do this research, we will need to collect, use, and share your private health information.  By 
signing this document, you agree that your health care providers (including both Vanderbilt 
University Medical Center and others) may release your private health information to us, and 
that we may use any and all of your information that the study team believes it needs to conduct 
the study.  Your private information may include things learned from the procedures described 
in this consent form, as well as information from your medical record (which may include 
information such as HIV status, drug, alcohol or STD treatment, genetic test results, or mental 
health treatment).   
Who will see, use or share the information?
The people who may request, receive or use your private health information include the 
researchers and their staff.  Additionally, we may share your information with other people at 
Vanderbilt, for example if needed for your clinical care or study oversight.  By signing this form, 
you give permission to the research team to share your information with others outside of 
Vanderbilt University Medical Center.  This may include the sponsor of the study and its agents 
or contractors, outside providers, study safety monitors, government agencies, other sites in the 
study, data managers and other agents and contractors used by the study team.   We try to 
make sure that everyone who sees your information keeps it confidential, but we cannot 
guarantee that your information will not be shared with others.  If your information is disclosed 
by your health care providers or the research team to others, federal and state confidentiality 
laws may no longer protect it.  
Do you have to sign this Authorization?
You do not have to sign this Authorization, but if you do not, you may not join the study. 
How long will your information be used or shared?
Date of IRB Approval: 4/4/2023
D
Comprehensive Postpartum Management for Women with Hypertensive 
Disorders of Pregnancy: a Randomized Controlled Trial 
4/4/2023
Sarah Osmundson, MD, MS 

VUMC Institutional Review Board 
Informed Consent Document for Research
Study Title:
Version Date:
PI:
5
This box is for
IRB USE ONLY
Do not edit or delete
Your Authorization for the collection, use, and sharing of your information does not 
expire.  Additionally, you agree that your information may be used for similar or related future 
research studies. 
What if you change your mind?
You may change your mind and cancel this Authorization at any time.  If you cancel, you must 
contact the Principal Investigator in writing to let them know by using the contact information 
provided in this consent form.  Your cancellation will not affect information already collected in the 
study, or information that has already been shared with others before you cancelled your 
authorization. 
You have the right to see and copy the PHI we gather on you for as long as the study doctor or 
research site holds this data.  To ensure the scientific quality of the research study, you will not 
be able to review some of your research data until after the research study is finished. 
If you decide not to take part in this research study, it will not affect your treatment, 
payment or enrollment in any health plans or affect your ability to get benefits. You will 
get a copy of this form after it is signed.  
STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY 
I have read this consent form and the research study has been explained to me verbally.  
All my questions have been answered, and I freely and voluntarily choose to take part in 
this study.    
Signature of patient
Date 
Signature of person obtaining consent
Date and time
Printed name and title
Date of IRB Approval: 4/4/2023
D
Comprehensive Postpartum Management for Women with Hypertensive 
Disorders of Pregnancy: a Randomized Controlled Trial 
4/4/2023
Sarah Osmundson, MD, MS