Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
Phase: NA
Conditions: High Blood Pressure (& [Essential Hypertension])
Sponsor: University of Kansas Medical Center

Official Study Title 
Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women 
in Kansas 
ClinicalTrials.gov Identiﬁer 
NCT Number: Pending registration at ClinicalTrials.gov 
Principal Investigator 
Sharla Smith, MPH, PhD 
University of Kansas Medical Center (KUMC) 
Study Sponsor 
National Institutes of Health (NIH) 
IRB Protocol Number 
STUDY00160319 
Version Date of This Protocol Document 
February 9, 2026 
 
Site Name: University of Kansas Medical Center 
Kansas City, Kansas 
 

KUMC – HRPP- 03/12/2015 
Page 1 of 18
University of Kansas Medical Center  
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS 
TEMPLATE WITH GUIDANCE 
Version date: 02.09.2026 
Principal Investigator: Sharla Smith 
Study Title: Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income 
Black Women in Kansas 
Noria McCarther, Sapphire Garcia, Oluoma Obi, Shea Kampsen, Claire Metcalf 
1. Protocol Synopsis
Study Design 
Prospective, two-arm randomized controlled trial; parallel assignment; open-label 
(behavioral/telehealth intervention). 
Randomization: 2:1 allocation using REDCap with variable block sizes. 
Framework: Practical, Robust Implementation, and Sustainability Model (PRISM) to guide 
implementation, adoption, effectiveness, maintenance, and pragmatism evaluation. 
Population 
Pregnant participants, age ≥18 years. 
English or Spanish speaking. 
Less than 13 weeks gestation at enrollment. 
Moderate or high risk for preeclampsia per USPSTF criteria. 
Intervention (Arm 2) 
Centering HER (HGPC-T): routine prenatal care plus 7 doula-led virtual group sessions (90 
minutes each) with OB/GYN fellow oversight. 
Participants receive Bluetooth BP cuff and (if applicable) Apple Watch; self-monitor and self-
report blood pressure and weight; complete surveys and medication log (if applicable). 
Comparator (Arm 1) 
Usual doula prenatal care and routine prenatal care visits with OB/GYN; completes study 
surveys. 
Primary/Key Outcomes (as stated in source protocol) 
Blood pressure rates; hypertension monitoring and aspirin compliance (# of women monitoring 
BP and aspirin compliance). 
Feasibility, acceptability, and contextual factors required for implementation. 
Duration 
Enrollment at <13 weeks gestation through postpartum survey completion (baseline, 
antepartum, and postpartum surveys). 
Data Sources 
REDCap surveys (baseline, antepartum, postpartum). 
Self-reported BP/weight (device-supported); medication log (if applicable). 
Electronic health record abstraction (clinical outcomes) as described in the source protocol. 
I.
Purpose, Background and Rationale
A. Aim and Hypotheses
1.
The study will use the Practical, Robust Implementation, and Sustainability Model
(PRISM) to implement Hypertension group prenatal care- telehealth (HGPC-T) also
known as Centering HER-health, empowerment, reproduction to reduce preeclampsia in
pregnancy (centering GPC, screening, monitoring, and aspirin) in community clinics.18

KUMC – HRPP- 03/12/2015 
Page 2 of 18
Based on PRISM, we will assess HGPC-T intervention development (e.g., organizational, 
providers, and patients’ perceptions); adoption (e.g. HGPC-T intervention adoption); the 
effectiveness (e.g., # of women monitoring hypertension and aspirin compliance); 
maintenance (e.g. intention to continue the HGPC-T); and pragmatism (e.g., adaptability 
of HGPC-T in other settings).18 The central hypothesis is that HGPC-T will lead to 
continuous monitoring of chronic hypertension, reduce early-onset preeclampsia, and 
reduce barriers to prenatal care.   
2.
Aim 1. To determine the feasibility, acceptability, and contextual factors required for the
implementation of the virtual GPC-T to reduce preeclampsia among low-income,
predominantly Black women. Aim 2. To pilot the virtual GPC-T and determine whether
virtual HGPC-T reduces preeclampsia among low-income, predominantly Black women.
Aim 3. To determine the effectiveness of virtual GPC to reduce preeclampsia among low-
income, predominantly Black women.
B. Background and Significance
1.
Study Significance: This research has the potential to reduce preeclampsia disparities by
considering system change in the delivery of maternal care, continuous monitoring of
blood pressure, reducing barriers in transportation and time off from work, improving
patient hypertension education, and improving social support and peer-to-peer learning.
2.
First, the study will allow us to determine the feasibility, acceptability, and contextual
factors required for the implementation of the HGPC-T to reduce disparities in EOP, which
to our knowledge, has not yet been done. Second, diverging from the status quo of
individual prenatal care treatment to reduce EOP, implementation of 81 mg of aspirin6
between 16 and 20 weeks, this study will pilot the virtual HGPC-T enhancement with a
hypertension intervention known to improve medication adherence and decrease
hypertension to reduce preeclampsia.
3.
Literature Review: (see Reference List)
4.
Importance of preeclampsia in the U.S. Preeclampsia, a potentially fatal pregnancy
condition characterized by high blood pressure, is estimated to complicate 3 percent to 6
percent of all pregnancies1-2. The rate of preeclampsia in the U.S. has increased 25
percent in the past two decades22. Preeclampsia is a leading cause of maternal and infant
illness and death1;4-5;8. Non-Hispanic Black women carry a 3- to 4 fold greater risk of
dying from pregnancy-related preeclampsia3;12;20. For example, preeclampsia is associated
with 20-30% preterm births and 15% low birth weight1;5. Moreover, a significant number
of women who get preeclampsia are at increased risk for cardiovascular disease after
pregnancy and throughout their lives.1;8;23
C. Rationale
1.
We posit that the implementation of HGPC-T for continuous high blood pressure
monitoring is a critical step in closing disparities in preeclampsia. This research has the
potential to reduce preeclampsia disparities by considering system change in the delivery
of maternal care, continuous monitoring of blood pressure, reducing barriers in
transportation and time off from work, improving patient hypertension education, and
improving social support and peer-to-peer learning.
2.
This research has the potential to reduce preeclampsia disparities by considering system
change in the delivery of maternal care continuous monitoring of blood pressure,
reducing barriers in transportation and time off from work, improving patient
hypertension education, and improving social support and peer-to-peer learning.

KUMC – HRPP- 03/12/2015 
Page 3 of 18
3.
The study may reduce preeclampsia and improve management of pregnancy-related
hypertension.
II.
Research Plan and Design
A. Study Objectives: The objective is to enhance the Centering GPC intervention with 
telehealth and take care of your blood pressure (TCYB) intervention for hypertension 
monitoring.
B. Study Type and Design: We will use REDCap software to assign 72 women in a 2:1 
randomization scheme in variable block sizes to, respectively, Centering -Health, 
Empowerment, Reproduction (HER) or usual doula care. You will have a 2 out of 3 chance to 
participate in the intervention. “Group assignments are random, like flipping a coin or rolling 
the dice.”
i.
Group 1-Non-Intervention
1.
Receive usual doula prenatal care including regular prenatal care visits.
2.
Participants will complete a baseline survey, antepartum study survey, and 
for postpartum survey
ii.
Group 2- Centering HER intervention
1.
Once selected for the study, you will participate in usual prenatal care visits 
with an OBGYN, 7 doula led virtual intervention sessions visits with an 
OBGYN fellow oversight.
2.
The 7 virtual meeting will be an hour and a half and led by a doula. A 
research staff member will be present to help with the coordination of the 
virtual intervention.
3.
You will receive 7 virtual visits with a group of women participating in the 
study
4.
Each telehealth/virtual visit will discuss blood pressure/hypertension, blood 
pressure, nutrition, weight management, exercise, and risk factors for 
hypertension.
5.
Participants will receive a Bluetooth blood pressure cuff, apple watch (if 
applicable), and doula tailored care to take your blood pressure and weight 
at home.
6.
Self-report blood pressure and weight
7.
Participants will complete a baseline survey, antepartum study survey, and 
for postpartum survey.
8.
Keep a medication log if applicable
Intervention Table 
Feature 
Group 1: Non-Intervention 
(Usual Doula Care) 
Group 2: Centering HER Intervention 
Prenatal Care 
Standard doula support + 
routine prenatal care with 
OB/GYN 
Routine prenatal care + 7 virtual doula-led 
intervention sessions with OB/GYN fellow 
oversight 

KUMC – HRPP- 03/12/2015 
Page 4 of 18
Feature 
Group 1: Non-Intervention 
(Usual Doula Care) 
Group 2: Centering HER Intervention 
Doula 
Involvement 
Yes – access to traditional 
doula support during prenatal 
visits 
Yes – virtual group doula-led health 
education and coaching 
Group Sessions 
None 
7 virtual group sessions (90 min each) 
with other pregnant participants 
Session Topics 
Not applicable 
Hypertension, blood pressure, nutrition, 
exercise, risk factors 
Technology 
Provided 
None 
Bluetooth BP cuff, Apple Watch (if 
applicable) 
Self-Monitoring 
No 
Participants self-monitor and report blood 
pressure and weight 
Survey 
Completion 
Baseline, antepartum, and 
postpartum surveys 
Baseline, antepartum, and postpartum 
surveys 
Medication 
Tracking 
No 
Keep medication log (if applicable) 
Research Staff 
Involvement 
Minimal such as surveys, 
reported blood pressure  
Yes – staff assist with coordinating virtual 
sessions 
Timeline 
Month 
Activities 
Milestones / Notes 
Month 0-
December 
Study Launch + IRB Finalization– Finalize recruitment 
materials– Train staff + doulas– Set up data tracking 
and virtual platforms 
IRB approval confirmed; 
staff orientation 
completed 
Month 1-
February 
Recruitment Begins– Begin enrolling both groups 
(target ~5 per group)– Distribute flyers, contact 
clinics, etc. 
First 10 participants 
enrolled (5 intervention, 
5 control) 
Month 2-3 
Continue Recruitment + Begin Intervention– Enroll 
next 10 participants– Begin Group 1 surveys– 
Intervention Group 1 starts Session 1 
~50% enrollment 
milestone reached 
Month 4 
Recruit Final Cohort– Enroll remaining 36 
participants– Distribute Apple Watches and BP cuffs– 
Start Sessions 1–2 for final intervention groups 
72 participants fully 
enrolled (36 per group) 
Month 5 
Midpoint Engagement– Intervention: Sessions 3–4 
(Blood Pressure, Nutrition)– Track self-monitoring 
data– Group 1 completes mid-surveys 
Monitor adherence and 
troubleshoot any tech 
issues 
Month 6 
Continue Sessions + Surveys– Sessions 5–6: Physical 
activity, medication awareness– Group 2 logs vitals– 
Group 1 continues routine care + surveys 
Most intervention 
participants complete 
75% of sessions 
Month 7 
Final Session + Postpartum Planning– Session 7: 
Doula support, preparing for delivery– Collect 
Sessions concluded for 
intervention group 

KUMC – HRPP- 03/12/2015 
Page 5 of 18
Month 
Activities 
Milestones / Notes 
antepartum surveys– Encourage postpartum follow-
up prep 
Month 8 
Final Data Collection + Postpartum Surveys– Collect 
postpartum survey from both groups– Finalize 
weight/BP logs– Export and clean dataset 
Study concludes; 
prepare for analysis and 
reporting 
C. Sample size, statistical methods, and power calculation
1.
Data will be checked for errors, inconsistencies, and missing values. Descriptive statistics
(e.g., mean and standard deviation for continuous variables and number and percent for
categorical variables) will be presented for all demographic variables, predictors of
interest, and outcomes. Chi-square and 2-sample t-tests will be used to compare the
outcomes among demographic groups and between different treatments.
2.
The participants will receive education on nutrition and exercise, will be asked to monitor
their blood pressure daily using blood pressure cuffs, and will receive the standard of
care of 81mg of aspirin per day (if applicable).
3.
This is a pilot project, so there is no power calculation for the project. The total number
of participants is 72.
D. Subject Criteria (See Vulnerable Populations appendix, if applicable):
1.
Inclusion criteria: English or Spanish speaking, <13 weeks gestations, >18 years old,
moderate or high risk for preeclampsia according to the United States Preventative
Services Task Force (USPSTF): High Risk: History of preeclampsia (especially with an
adverse outcome): Multifetal gestation; Chronic hypertension; Pregestational type 1 or
type 2 diabetes; Kidney disease; Autoimmune disease (e.g., systemic lupus
erythematosus, antiphospholipid syndrome) Moderate Risk: Nulliparity (first
pregnancy); Obesity (pre-pregnancy BMI > 30); Family history of preeclampsia (mother
or sister); Black persons (due to social, not biological, factors); Lower income; Age ≥ 35
years;  Personal history factors (e.g., low birth weight or small for gestational age,
previous adverse pregnancy outcome, >10-year pregnancy interval); In vitro conception
(IVF)
2.
Exclusion criteria: <18 and not receiving prenatal care or eligible for doula care
3.
Withdrawal/Termination criteria: N/A
4.
N/A
E. Specific methods and techniques used throughout the study
1.
Laboratory tests: N/A
2.
Study Procedures: The control group will receive usual care from OBGYN and usual
doula counselling and complete surveys. The study’s intervention will be conducted as 7
usual care visits with OBGYN and 7 virtual group visits, including a group of women in
the study. Each participant will also have access to usual doula counselling. Each virtual
visit will discuss nutrition, high blood pressure/hypertension, exercise, weight

KUMC – HRPP- 03/12/2015 
Page 6 of 18
management, and risk factors for hypertension. Each participant will receive a blood 
pressure cuff and scale to take their blood pressure and weight at home.  
3. Each participant will be expected to complete a consent, attend virtual group sessions,
complete the medication log if applicable and complete the surveys.
4.
N/A
5.
Timeline: N/A
F. Risk/benefit assessment:
1.
Foreseeable Risks
•
Privacy and confidentiality: risk of unintended disclosure of pregnancy/health
information through study records or virtual sessions.
•
Group-session confidentiality limits: other participants may share information outside
the group despite agreements.
•
Psychological or emotional discomfort: discussing pregnancy, health behaviors,
barriers to care, or social stressors may be upsetting.
•
Device-related risks: minor discomfort with cuff use; anxiety related to elevated
readings; potential for inaccurate readings.
•
Time and inconvenience: time required for surveys, virtual sessions, and daily
BP/weight monitoring.
2. Risk Mitigation
•
Use REDCap and secure institutional storage (p:protecteddata drive) with role-based
access; store identifiers separately from analytic datasets.
•
Use virtual-session ground rules and confidentiality agreements; allow participants to
use first name or preferred name in group.
•
Provide clear instructions that participants should not change medications based on
home readings without contacting their clinician; provide escalation guidance for
severe readings.
•
Offer option to skip any survey question and request private follow-up for sensitive
concerns
3.
Potential Benefits
•
Consistent with the source protocol, potential benefits include improved ability to
monitor blood pressure, increased hypertension education, and peer-to-peer social
support; benefits are not guaranteed.
G. Location where study will be performed: University of Kansas Medical Center
H. Collaboration (with another institution, if applicable):   N/A
I.
Single IRB Review for a Multi-site study (if applicable):
1.
For which sites will KUMC serve as the IRB of record? N/A
2.
Indicate which study activities will occur at each site. If all study procedures will be
identical across study sites, state this.  N/A
3.
Describe how you will assess the capacity of each site to perform the research (e.g.,
expertise, staffing, space, equipment, etc.)  If applicable, include site evaluation tools in
your IRB submission.  N/A
4.
Describe how the lead investigators will ensure that all participating sites use the IRB-
approved version of the protocol, consent, recruitment materials and other study
documents. N/A

KUMC – HRPP- 03/12/2015 
Page 7 of 18
5.
Describe how the lead investigators will communicate with and disseminate new
information to other sites (e.g., training meetings, regularly scheduled conference calls,
notifications, etc.) N/A
6.
Describe how the lead investigator will assess protocol compliance, unanticipated
problems and adverse events at other sites. N/A
7.
Name the member of the KUMC study team who will be the point of contact to coordinate
oversight and communication with the sites.  N/A
J.
Community-Based Participatory Research (if applicable)
1.
Participants and the nature of their involvement: N/A
2.
Cultural issues:   N/A
3.
Origin of the research question:  N/A
4.
Risks and Benefits:   N/A
5.
Study Description and Process:  N/A
6.
Return of results:  N/A
7.
Sustainability: N/A
K. Personnel who will conduct the study, including:
1.
Indicate, by title, who will be present during study procedure(s): Sharla Smith, Sapphire
Garcia, Noria McCarther, Oluoma Obi, Shea Kampsen, and Claire Metcalf.
2.
Primary responsibility for the following activities, for example:
a.
Determining eligibility: Sharla Smith, Sapphire Garcia, Noria McCarther, and
Oluoma Obi
b.
Obtaining informed consent: Sharla Smith, Sapphire Garcia, Noria McCarther,
Shea Kampsen, Claire Metcalf, and Oluoma Obi
c.
Providing on-going information to the study sponsor and the IRB: Sharla Smith,
Sapphire Garcia, Noria McCarther, and Oluoma Obi
d.
Maintaining participant's research records: Sharla Smith, Sapphire Garcia, Noria
McCarther, Shea Kampsen, Claire Metcalf and Oluoma Obi
e.
Completing physical examination: N/A
f.
Taking vital signs, height, weight: Doula (Sapphire Garcia)
g.
Drawing / collecting laboratory specimens: N/A
h.
Performing / conducting tests, procedures, interventions, questionnaires: N/A
i.
Completing study data forms: Sharla Smith, Noria McCarther, Sapphire Garcia,
Oluoma Obi, and Shea Kampsen
j.
Managing study database: Sharla Smith, Noria McCarther, Sapphire Garcia,
Oluoma Obi, and Shea Kampsen
L.
Assessment of Subject Safety and Development of a Data and Safety Monitoring
Plan

KUMC – HRPP- 03/12/2015 
Page 8 of 18
1.
Elements of the plan include:
a.
Persons/groups who will review the data (study team; independent safety
monitor, data monitoring committee or formal DSMB) Sharla Smith
b.
Data/events that will be reviewed
c.
Frequency of review Quarterly
d.
Types of analyses to be performed Descriptive
e.
Safety-related triggers that would cause the PI to stop or alter the study N/A
3.
Describe how adverse events and unanticipated problems will be ascertained and
handled.  Explain exactly which type of problems will be considered serious and reported
to the IRB. The reporting timeframe should also be detailed. N/A
Explain exactly what will happen if a patient experiences an adverse event or other
problem (for example, will discontinue study participation). N/A
III.
Subject Participation
A. Recruitment:
1.
University of Kansas Medical Center Utilizing community recruitment without a
designated institution.
2.
Target emails and text to patients enrolled in the doula network and sacred care.
3.
KBEN stakeholder organizations (n=90) will distribute flyers. Community Health Workers
will distribute flyers in Sedgwick and Wyandotte Counties
4.
Flyers online via social media and with local community organizations.
B. Screening Interview/questionnaire: Inclusion Criteria
Yes
C. Informed consent process and timing of obtaining of consent
1 
Sharla Smith, Oluoma Obi, and Shea Kampsen
2 
Participants will be given an opportunity to review the consent, and consent will be read
to participants, and time will be allocated for questions and concerns, participants will be 
informed that participation is voluntary.  
3 
 Consent will only be completed by individuals participating. 
D. Alternatives to Participation: Usual Prenatal Care and provision of doula care
E. Costs to Subjects: N/A
F. How new information will be conveyed to the study subject and how it will be
documented: New information will be provided as written communication at an eighth-
grade level.
G. Payment, including a prorated plan for payment: Participants will be compensated for
their time as follows: $25 per intervention session, $25 after completing baseline surveys,
$25 after completing the antepartum study visit surveys at the last visit before delivery, and
$50 after completing the postpartum surveys.

KUMC – HRPP- 03/12/2015 
Page 9 of 18
H. Payment for a research-related injury: N/A
IV.
Data Collection and Protection
A. Data Management and Security: Data collected in blood pressure.
1.
Data will be stored on the p:protecteddata drive
2.
No, coded numbers will be used
3.
Sharla Smith
4.
codes
5.
p:protecteddata drive
6.
N/A
7.
N/A
B. Sample / Specimen Collection: N/A
C. Tissue Banking Considerations:  N/A
D. Procedures to protect subject confidentiality:
A. General Approach
Participant confidentiality will be protected through data minimization, coding/de-
identification, secure storage, and role-based access. Only the minimum necessary
identifiable information will be collected to conduct study procedures and link
survey/device/EHR data.
B. Study IDs and Linkage File
•
Each participant will be assigned a unique Study ID at enrollment.
•
Identifiers (e.g., name, DOB, phone, email, medical record number) will be stored in
a separate linkage file (“master key”) that links identifiers to Study IDs.
•
The linkage file will be stored in a restricted-access, encrypted institutional location
(e.g., secure server drive) separate from research datasets.
•
Research datasets used for analysis will contain Study IDs only whenever feasible.
C. Data Collection Platforms (REDCap / Surveys)
•
Surveys will be collected using REDCap (or equivalent HIPAA-aligned institutional
system) with:
o
Role-based permissions (least-privilege access)
o
Unique user logins
o
Audit trails enabled to track data access and changes
•
Surveys will avoid collecting unnecessary identifiers. When contact data is needed for
follow-up, it will be stored in a contact module separate from outcomes data.
D. Electronic Health Record (EHR) Data
•
EHR data abstraction will be limited to minimum necessary fields (e.g., BP values,
visit dates, delivery outcomes, diagnoses relevant to preeclampsia risk).
•
EHR extracts will be stored using Study IDs, with MRNs retained only in the separate
linkage file (unless institutional policy requires temporary MRN storage for
abstraction).
•
Only authorized study staff with institutional training and access will conduct EHR
review.
E. Device/App Data (e.g., Bluetooth BP cuff / wearable)
•
Participants will be instructed not to transmit identifiable medical details through free-
text fields.
•
Device measurements will be linked to Study IDs in REDCap (or secured data
repository).
•
If vendor platforms are used, only necessary data will be collected and exported to
the secure institutional environment as soon as feasible.

KUMC – HRPP- 03/12/2015 
Page 10 of 18
•
Any exports will be stored as coded data with Study IDs; raw exports with identifiers
(if unavoidable) will be stored separately with restricted access.
F. Virtual and Group Session Confidentiality (if applicable)
Because group sessions involve multiple participants, confidentiality protections
include:
•
Participants will sign a Group Confidentiality Agreement stating they will not share
information discussed in the group outside the group.
•
At the start of each session, facilitators will review ground rules:
o
Share only what you are comfortable sharing
o
Do not record the session
o
Use headphones and join from a private space when possible
o
Respect privacy and avoid using others’ full names
•
Sessions will not be recorded unless explicitly approved by the IRB and included in
the consent form.
•
Facilitators will discourage disclosure of highly identifying details during group
sessions and offer a pathway for private follow-up for sensitive concerns.
G. Staff Training and Confidentiality Obligations
•
All study personnel will complete required training (e.g., human subjects protection,
HIPAA/privacy, data security).
•
Study team members will sign confidentiality agreements as required by institutional
policy.
•
Access to identifiable information will be limited to staff who require it for
recruitment, scheduling, or clinical escalation.
H. Data Storage, Encryption, and Access Controls
•
All electronic study data will be stored on encrypted, access-controlled institutional
servers or approved secure cloud environments.
•
Portable devices (laptops, external drives) will not store identifiable data unless
encrypted and institutionally approved.
•
Email/text communications will use minimum necessary information. Identifiers will
not be shared in unsecured messages beyond what is necessary for scheduling.
•
Paper documents (if any) will be stored in a locked cabinet in a locked office; access
limited to authorized staff.
I. Data Sharing, Reporting, and Publication
•
Results will be reported in aggregate form only.
•
No individual participant will be identifiable in publications or presentations.
•
Any sharing of de-identified datasets with collaborators will use a data use agreement
as required, and only de-identified/coded data will be shared unless IRB approval and
HIPAA authorization permit otherwise.
J. Data Retention and Destruction
•
Study records will be retained for [X years] after study completion in accordance with
institutional and sponsor requirements.
•
After the retention period, identifiable files (including linkage files) will be securely
destroyed per institutional policy.
K. Privacy Limits and Mandatory Reporting
Participants will be informed that confidentiality may be limited in cases of:
•
Immediate risk of harm to self or others
•
Suspected child abuse/neglect or other mandatory reporting obligations
In the event of a suspected privacy breach: 
•
The PI will be notified immediately.
•
Institutional privacy/security offices will be contacted per policy.
•
The IRB will be notified according to institutional reporting timelines.
•
Participants will be notified if required by policy/law.
E. Quality Assurance / Monitoring

KUMC – HRPP- 03/12/2015 
Page 11 of 18
1.
Data will be collected via electronic health record abstraction, instruments
administered to patients, and self-report of blood pressure and medication adherence.
All data will be collected on standardized forms (on which nearly all responses will be
pre-coded) in REDCap.
2.
N/A
V. Data Analysis and Reporting
A. Statistical and Data Analysis: Data will be checked for errors, inconsistencies, and
missing values. Descriptive statistics (e.g., mean and standard deviation for continuous
variables and number and percent for categorical variables) will be presented for all
demographic variables, predictors of interest, and outcomes. Chi-square and 2-sample t-
tests will be used to compare the outcomes among demographic groups and between
different treatments.
B. Outcome:   Blood pressure rates
i.
Hypertensive-range BP is defined as SBP ≥140 and/or DBP ≥90 mm Hg; severe-range BP
is SBP ≥160 and/or DBP ≥110 mm Hg.
ii.
Severe-range hypertension (obstetric emergency threshold): SBP ≥160 or DBP ≥110
C. Study results to participants:  N/A
D. Publication Plan: Three publications will be done: Implementation of the study, analysis of
study results, and health behaviors of participants.
E. Bibliography / References / Literature Cited

KUMC – HRPP- 03/12/2015 
Page 12 of 18
1. Lisonkova S, Joseph KS. Incidence of preeclampsia: risk factors and outcomes associated with
early- versus late-onset disease. American Journal of Obstetrics & Gynecology 2013;209:544.
2. ACOG. Gestational Hypertension and Preeclampsia. Obstetrics & Gynecology 2019;133:1-25.
3. Ghosh G, Grewal J, Mist T et al. Racial/ethnic differences in pregnancy-related hypertensive disease
in nulliparous women. Ethn Dis 2014;24:283-289.
4. Sibai B. Diagnosis and Management of Gestational Hypertension and Preeclampsia. Obstetrics and
Gynecology (New York 1953) 2003;102:181-192.
5. Backes CH. Maternal preeclampsia and neonatal outcomes. Journal of pregnancy 2011;2011:1-7.
6. Rolnik DL, Wright D, Poon LCY et al. ASPRE trial: performance of screening for preterm pre-
eclampsia. Ultrasound Obstet Gynecol 2017;50:492-495.
7. Tan MY, Poon LC, Rolnik DL et al. Prediction and prevention of small-for-gestational-age neonates:
evidence from SPREE and ASPRE. Ultrasound Obstet Gynecol 2018;52:52-59.
8. Raymond D. A critical review of early-onset and late-onset preeclampsia. Obstetrical &
gynecological survey 2011;66:497-506.
9. Lisonkova S, Joseph KS. Incidence of preeclampsia: risk factors and outcomes associated with
early- versus late-onset disease. American Journal of Obstetrics and Gynecology 2013;209:544.
10. Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for
Prevention of Preeclampsia. Drugs 2017;2017/10/16:1819-1831.
11. Mone F, ÖMahony JF, Tyrrell E et al. Preeclampsia Prevention Using Routine Versus Screening
TestGÇôIndicated Aspirin in Low-Risk Women. Hypertension 2018;72:1391-1396.
12. Bryant AS, Worjoloh A, Caughey AB, Washington AE. Racial/ethnic disparities in obstetric outcomes
and care: prevalence and determinants. American Journal of Obstetrics and Gynecology
2010;202:335-343.
13. Louis JM, Bryant A, Ramos D, Stuebe A, Blackwell SC. Interpregnancy Care. American Journal of
Obstetrics and Gynecology 2019;220:B2-B18.
14. Fingar KR, Mabry-Hernandez IM, Ngo-Metzger Q, Wolf T, Steiner C, Elixhauser A. Delivery
Hospitalizations Involving Preeclampsia and Eclampsia, 2005-2014. Healthcare Cost and Utilization
Project.4-1-2017.
15. Stefano Omboni, Richard J. McManus, Hayden B. Bosworth, Lucy C. Chappell, Beverly B. Green,
Kazuomi Kario, Alexander G. Logan, David J. Magid, Brian Mckinstry, Karen L. Margolis, Gianfranco
Parati, Bonnie J. Wakefield.Evidence and Recommendations on the Use of Telemedicine for the
Management of Arterial Hypertension.  Hypertension. November 2020;Vol 76, Issue 5.
16. Finkelstein J, Cha E. Hypertension telemanagement in blacks. Circ Cardiovasc Qual Outcomes. 2009
May;2(3):272-8.
17. McLean, Gary; Band, Rebecca; Saunderson, Kathryn; Hanlon, Peter; Murray, Elizabeth; Little, Paul;
McManus, Richard J.; Yardley, Lucy; Mair, Frances S. on behalf of the DIPSS co-investigators Digital
interventions to promote self-management in adults with hypertension systematic review and meta-
analysis, Journal of Hypertension: April 2016 - Volume 34 - Issue 4 - p 600-612.
18. Bosworth HB, Olsen MK, Neary A, Orr M, Grubber J, Svetkey L, Adams M, Oddone EZ. Take Control
of Your Blood Pressure (TCYB) study: a multifactorial tailored behavioral and educational

 
KUMC – HRPP- 03/12/2015 
 
Page 13 of 18
 
 
 
intervention for achieving blood pressure control. Patient Educ Couns. 2008 Mar;70(3):338-47. doi: 
10.1016/j.pec.2007.11.014. Epub 2007 Dec 31. PMID: 18164894; PMCID: PMC2276731. 
19. Adrianne C. Feldstein, Russell E. Glasgow, A Practical, Robust Implementation and Sustainability 
Model (PRISM) for Integrating Research Findings into Practice, The Joint Commission Journal on 
Quality and Patient Safety, Volume 34, Issue 4, 2008, Pages 228-243. 
20. Bird TM, Bronstein JM, Hall RW, Lowery CL, Nugent R, Mays GP. Late Preterm Infants: Birth 
Outcomes and Health Care Utilization in the First Year. Pediatrics 2010;126:e311. 
21. Poon LC, Wright D, Rolnik DL et al. Aspirin for Evidence-Based Preeclampsia Prevention trial: effect 
of aspirin in prevention of preterm preeclampsia in subgroups of women according to their 
characteristics and medical and obstetrical history. American Journal of Obstetrics and Gynecology 
2017;217:585. 
22. Fantasia HC. Low-Dose Aspirin for the Prevention of Preeclampsia. Nursing for Women's Health 
2018;22:87-92. 
23. Tong S, Mol BW, Walker SP. Preventing preeclampsia with aspirin: does dose or timing matter? 
American Journal of Obstetrics and Gynecology 2017;216:95-97. 
24. Tanaka M, Jaamaa G, Kaiser M et al. Racial disparity in hypertensive disorders of pregnancy in New 
York State: a 10-year longitudinal population-based study. Am J Public Health 2007;97:163-170. 
25. Nakimuli A, Chazara O, Byamugisha J et al. Pregnancy, parturition and preeclampsia in women of 
African ancestry. American Journal of Obstetrics and Gynecology 2014;210:510-520. 
26. Jeyabalan A. Epidemiology of preeclampsia: impact of obesity. Nutr Rev. 2013 Oct;71 Suppl 1(0 
1):S18-25. doi: 10.1111/nure.12055. PMID: 24147919; PMCID: PMC3871181. 
27. Craici I, Wagner S, Garovic VD. Preeclampsia and future cardiovascular risk: formal risk factor or 
failed stress test? Ther Adv Cardiovasc Dis. 2008 Aug;2(4):249-59. doi: 
10.1177/1753944708094227. PMID: 19124425; PMCID: PMC2674507. 
28. Does race or ethnicity play a role in the origin, pathophysiology, and outcomes of preeclampsia? An 
expert review of the literatureJasmine D. Johnson, MD Judette M. Louis, MD, MPH Published:July 24, 
2020.DOI:https://doi.org/10.1016/j.ajog.2020.07.038 
29. VOLUME 11, ISSUE 4, P382-388, AUGUST 01, 2007Centering Pregnancy®: A Model for Group 
Prenatal CareJacquelyn Reid, WHNP, CNM, CNE 
30. Manant, Annette, AU  - Dodgson, Joan E. CenteringPregnancy: An Integrative Literature Review. 
Journal of Midwifery & Women's Health,56(2) 1526-9523. 
31. Thielen K. Exploring the group prenatal care model: a critical review of the literature. J Perinat 
Educ. 2012 Fall;21(4):209-18. doi: 10.1891/1058-1243.21.4.209. PMID: 23997549; PMCID: 
PMC3489125. 
32. Ching-Ming Liu, Shuenn-Dyh Chang, Po-Jen Cheng, Relationship between prenatal care and 
maternal complications in women with preeclampsia: Implications for continuity and discontinuity of 
prenatal care, Taiwanese Journal of Obstetrics and Gynecology, Volume 51, Issue 4, 2012, Pages 
576-582 
33. Kominiarek MA, Crockett A, Covington-Kolb S, Simon M, Grobman WA. Association of Group 
Prenatal Care With Gestational Weight Gain. Obstet Gynecol. 2017 Apr;129(4):663-670. doi: 
10.1097/AOG.0000000000001940. PMID: 28277365; PMCID: PMC5364062. 
34. Preterm Labor: Prevention and Management PDF  PRINT  COMMENTSKRISTEN RUNDELL, MD, and 
BETHANY PANCHAL, MD, The Ohio State University Wexner Medical Center, Columbus, OhioAm Fam 
Physician. 2017 Mar 15;95(6):366-372. 
35. Megan M. Schellinger1 • Mary Pell Abernathy1 • Barbara Amerman3 •Carissa May1 • Leslie A. 
Foxlow1 • Amy L. Carter3 • Kelli Barbour1 •Erin Luebbehusen1 • Katherine Ayo1 • Dina Bastawros1 
• Rebecc S. Rose2 •David M. Haas Improved Outcomes for Hispanic Women with Gestational 

KUMC – HRPP- 03/12/2015 
Page 14 of 18
Diabetes Using the Centering Pregnancy Group Prenatal Care Model. Matern Child Health J (2017) 
21:297–305 
36. Shayna D. Cunningham, Jessica B. Lewis, Fatma M. Shebl, Lisa M. Boyd, Marc A. Robinson,
Stephanie A. Grilo, Susan M. Lewis, Anne L. Pruett, and Jeannette R. Ickovics. Group Prenatal Care
Reduces Risk of Preterm Birth and Low Birth Weight: A Matched Cohort Study. Journal of Women's
Health 2019 28:1, 17-22
37. Ickovics JR, Kershaw TS, Westdahl C, Magriples U, Massey Z, Reynolds H, Rising SS. Group prenatal
care and perinatal outcomes: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt
1):330-9. doi: 10.1097/01.AOG.0000275284.24298.23. Erratum in: Obstet Gynecol. 2007
Oct;110(4):937. PMID: 17666608; PMCID: PMC2276878.
38. Vekved M, McNeil DA, Dolan SM, Siever JE, Horn S, Tough SC. Invested in Success: A Qualitative
Study of the Experience of CenteringPregnancy Group Prenatal Care for Perinatal Educators. J
Perinat Educ. 2017;26(3):125-135. doi: 10.1891/1058-1243.26.3.125. PMID: 30723376; PMCID:
PMC6354628.
39. Kansas Department of Environmental Health. Kansas Maternal Mortality Report 2016-2018. Dec.
2020. https://kmmrc.org/wp-content/uploads/2021/02/KS-Maternal-Morbidity-Mortality-
Report_Dec-2020_FINAL2-21.pdf

 
KUMC – HRPP- 03/12/2015 
 
Page 15 of 18
 
 
 
APPENDIX I: VULNERABLE POPULATIONS 
 
I. 
Pregnant women ages 18-35, pregnant women data will be protected on the p:drive for surveys, 
no medical data will be provided during group discussions, participants will be asked to use their 
first names during group or a name they would like to use.  
 
II. 
Cognitively or decisionally impaired individuals: N/A 
 
III. 
Children: N/A 
 
IV. 
Pregnant women: Yes 
 
V. 
Prisoners: N/A 
 
VI. Students and/or Employees:  
 
A. N/A 
 
B. N/A 
 
C. N/A 
 
17. Attachments List (IRB Submission Packet) 
Attachment 1: Informed Consent Form template (Appendix A). 
Attachment 2: Recruitment materials and scripts (Appendix B). 
Attachment 3: Virtual Group Confidentiality Agreement (Appendix C). 
Attachment 4: Safety workflows (Appendix D): Severe BP escalation; Acute distress/suicidality 
response (as applicable). 
Attachment 5: Measures/Instrument packet (Appendix E): baseline/antepartum/postpartum surveys; 
BP/weight log; medication log (if applicable). 
Attachment 6: Schedule of Events and Timeline tables (Sections 4.1 and 5). 
Attachment 7: Data and Safety Monitoring Plan details (Section 10). 
 
Appendix A. Informed Consent Form (Template) 
Study Title: Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women 
in Kansas 
Principal Investigator: Sharla Smith (contact: [insert email/phone]) 
 
Invitation to Participate 
You are being invited to take part in a research study because you are pregnant and may be eligible 
based on your pregnancy stage and risk factors for preeclampsia. Participation is voluntary. 
Purpose 
The purpose of this study is to test two ways of supporting prenatal care to help reduce early-onset 
preeclampsia by improving blood pressure monitoring, aspirin adherence, and reducing barriers to 
prenatal care. 
Procedures 

KUMC – HRPP- 03/12/2015 
Page 16 of 18
If you join, you will complete surveys at baseline, later in pregnancy (antepartum), and after delivery 
(postpartum). 
You will be assigned by chance (like flipping a coin) to one of two groups: usual doula care or Centering 
HER (virtual group sessions). 
If assigned to Centering HER, you will participate in 7 doula-led virtual group sessions (about 90 
minutes each) and will be provided a Bluetooth blood pressure cuff and, if applicable, an Apple Watch 
to support home monitoring. 
You may be asked to keep a medication log if applicable and self-report blood pressure and weight as 
instructed. 
Randomization 
Group assignment is random and neither you nor the study team can choose your group. 
Risks 
Some questions may feel personal. You can skip any question. 
Because some sessions are done in a group, the study team cannot guarantee other participants will 
keep information private. We will ask everyone to sign a confidentiality agreement. 
Using a blood pressure cuff may cause minor discomfort. Seeing high blood pressure readings may be 
stressful. You will receive instructions on when to contact your care team or seek urgent care. 
Benefits 
You may learn skills and receive support to monitor your blood pressure and support healthy pregnancy 
behaviors, but benefits are not guaranteed. 
Confidentiality 
Study data will be stored securely. We will use a study ID number when possible. Group confidentiality 
has limits because other participants are not study staff. 
Compensation 
Participants will be compensated: $25 for each intervention session; $25 after completing baseline 
surveys, $25 after completing antepartum surveys, and $50 after completing postpartum surveys. 
Voluntary Participation 
You may refuse or stop at any time without affecting your care or benefits. 
Questions 
If you have questions about the study, contact the study team at [insert]. For questions about your 
rights, contact the KUMC IRB at [insert]. 
Participant Name (print): ____________________________ 
Participant Signature: ______________________________   Date: ____________ 
Person Obtaining Consent: __________________________   Date: ____________ 
Appendix B. Recruitment Materials and Scripts (Templates) 
B1. In-clinic Intro (Clinic Staff)/Doula  
Hi, our clinic is partnering with the University of Kansas Medical Center on a study testing ways to 
support prenatal care and blood pressure monitoring to reduce preeclampsia. Would you like to hear 
more from the research team? Participation is voluntary and will not affect your care. 
B2. Research Staff Phone/Private Screening Script 
Confirm the person is in a private place to talk. 
Explain the study compares usual doula care versus a Centering HER virtual group prenatal support 
program. 

KUMC – HRPP- 03/12/2015 
Page 17 of 18
Explain random assignment and what participation involves (surveys; possible virtual group sessions; 
home BP monitoring). 
Explain voluntary nature; answer questions; schedule consent visit. 
B3. Text/Portal Message Template 
Your clinic is partnering on a prenatal research study to reduce preeclampsia by improving blood 
pressure monitoring and support. If you are interested in learning more, reply to this message or call 
[phone]. Participation is voluntary. 
Appendix C. Virtual Group Confidentiality Agreement 
I understand virtual group prenatal sessions involve discussion with other participants. 
I agree to respect others’ privacy and not share personal stories or names outside the group. 
I understand the research team cannot guarantee confidentiality because other participants are not 
staff. 
I may choose what to share and may request private follow-up with the doula or study staff. 
I understand staff may need to break confidentiality to address immediate safety concerns or 
mandatory reporting obligations. 
Participant Name (print): ____________________________ 
Participant Signature: ______________________________   Date: ____________ 
Appendix D. Safety Workflows (SOP) 
D1. Severe Blood Pressure Escalation Workflow 
Trigger: Any home blood pressure reading in the severe range (e.g., systolic ≥160 and/or diastolic 
≥110), or symptoms suggestive of hypertensive emergency (e.g., severe headache, vision changes, 
chest pain, shortness of breath, RUQ pain). 
If severe BP or severe symptoms: instruct participant to seek emergency care immediately (call 911 or 
go to the nearest emergency department). 
If elevated but not severe: instruct participant to repeat measurement after 5–10 minutes of rest and 
contact their prenatal care team the same day for guidance. 
Document the report (date/time, reading, symptoms, actions taken) in REDCap safety log. 
Notify PI or designee within 24 hours of any severe-range report. 
Appendix E. Measures and Instruments Packet (Inventory) 

KUMC – HRPP- 03/12/2015 
Page 18 of 18
Instrument / Data Source 
Purpose 
Timepoints 
Notes / Storage 
Baseline Survey 
(REDCap) 
Demographics, baseline 
health 
behaviors/knowledge, 
baseline outcomes per 
study measures table 
Baseline (<13 
weeks) 
Store in REDCap; 
authorized versions in 
regulatory binder 
Antepartum Survey 
(REDCap) 
Follow-up outcomes and 
process measures 
Late pregnancy 
/ last prenatal 
visit before 
delivery 
Store in REDCap 
Postpartum Survey 
(REDCap) 
Postpartum outcomes and 
acceptability 
Postpartum 
Store in REDCap 
Home BP and Weight Log 
(device-supported) 
Daily/regular monitoring 
Throughout 
participation 
Self-report; Bluetooth 
cuff/Apple Watch (if 
applicable) 
Medication Log (if 
applicable) 
Aspirin and/or 
antihypertensive adherence 
tracking 
Throughout 
participation 
Self-report; may be 
verified by doula if built 
into workflow 
EHR Abstraction 
Clinical outcomes including 
blood pressure, prenatal 
care utilization, delivery 
outcomes (as defined) 
Ongoing / 
postpartum 
Minimum necessary 
data; stored on 
p:protecteddata drive