Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Phase: NA
Conditions: Postpartum Anemia Nos
Sponsor: University of Pennsylvania

SMaRT Blood: Single-unit Versus Multiple-
unit Packed Red Blood Cell Transfusion in 
Non-acute Postpartum Anemia 
 
NCT03419780 
 
February 15, 2018 

Page 1 of 15
Protocol Details
Basic Info
Conﬁrmation Number:
cﬁcgcid
Protocol Number:
829141
Created By:
HAMM, REBECCA F
Principal Investigator:
SRINIVAS, SINDHU
Protocol Title:
Can a single-unit blood transfusion protocol in obstetrics reduce number of units transfused? A randomized, cont
trial
Short Title:
SMaRT Blood: Single-unit versus Multiple-unit Packed Red Blood Cell Transfusion in non-acute postpartum anem
Protocol Description:
There is a paucity of data on management of non-acute postpartum anemia. Although blood 
transfusions were historically initiated with 2 units, the most recent recommendation from the 
American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials 
have been performed in obstetrics, we propose a randomized, controlled trial in non-acute 
postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units 
transfused and maternal morbidity.
Submission Type:
Biomedical Research
Application Type:
FULL
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
SRINIVAS, SINDHU
Dept / School / Div:
4333 - OB-Obstetrics and Gynecology
Campus Address
Mail Code
4283
Address:
2 Silverstein
3400 Spruce Street
City State Zip:
Philadelphia PA 19104-4283
Phone:
215-898-0825
Fax:
215-573-7627
Pager:
Email:
ssrinivas@obgyn.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
04/05/2018
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

SMaRT Blood: Single-unit Versus Multiple-
unit Packed Red Blood Cell Transfusion in 
Non-acute Postpartum Anemia 
 
NCT03419780 
 
February 15, 2018 

Page 2 of 15
Study Contacts
None
Other Investigator
Name:
HAMM, REBECCA F
Dept / School / Div:
4333 - OB-Obstetrics and Gynecology
Campus Address
Mail Code
4283
Address:
2 Silverstein
3400 SPRUCE ST 
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
215-662-2459
Fax:
-
Pager:
Email:
Rebecca.FeldmanHamm@uphs.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
06/16/2019
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Responsible Org (Department/School/Division):
4333 - OB-Obstetrics and Gynecology
Key Study Personnel
None
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
Biomedical Research
Clinical Trial*
Is this a clinical trial?
Yes

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If Yes, please be aware that for each clinical trial conducted or supported by a Federal department or 
agency, one IRB-approved informed consent form used to enroll subjects must be posted by the 
awardee or the Federal department or agency component conducting the trial on a publicly available 
Federal Web site that will be established as a repository for such informed consent forms.
Investigator Initiated Trial*
Is this an investigator initiated trial?
Yes
If Yes, please be aware that the investigator may be required to create and manage a record of this trial 
in https://clinicaltrials.gov.
Drugs or Devices*
Does this research study involve Drugs or Devices?
Yes: Drugs, products or devices are used in accordance with FDA approval.
IND Exemption
For studies that fall under an IND exemption, please provide the number below
For studies including IND or IDE's, please provide the number(s) below
IDE Review*
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https://
www.med.upenn.edu/pennmanual/secure/investigational-product-management-at-sites-not-using-
investigational-drug-services-(ids).html Please check the box Yes if you have reviewed the guidance.
Yes
Research Device Management*
Please indicate how research device(s) will be managed.
Not Applicable (no investigational devices)
Drug, Herbal Product or Other Chemical Element Management *
Please indicate how drugs, herbal products or other chemical entities will be managed.
Not Applicable (no drugs, herbal products or other chemical entities)
Radiation Exposure*
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?
No
Gene Transfer*
Does this research involve gene transfer (including all vectors) to human subjects?
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)?
No
CACTIS and CT Studies*
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) 
and CT studies that research subjects would not receive if they were not part of this protocol?
No
CAMRIS and MRI Studies*
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this 

Page 4 of 15
protocol?
No
Investigational Agent or Device within the Operating Room*
Does the research project involve the use of an investigational agent or device within the Operating 
Room?
No
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories?
No
Processing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
In-House Manufacturing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
Yes
If the answer is YES, indicate which items is is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
CTRC Resources*
Does the research involve CTRC resources?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
No

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Primary Focus*
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes)
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
x Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Sponsors
Business Administrator
none
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
Regulatory Sponsor
IND Sponsor
none
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Industry Sponsor
None
Project Funding*
Is this project funded by or associated with a grant or contract?
No

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Sponsor Funding
Is this study funded by an industry sponsor?
Status of contract
The following documents are currently attached to this item:
There are no documents attached for this item.
Multi-Site Research
Other Sites
No other sites
Management of Information for Multi-Center Research
The following documents are currently attached to this item:
There are no documents attached for this item.
Protocol
Abstract
Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most 
important cause of maternal morbidity and mortality across the globe and is a focus of attention of 
national organizations such as the Council for Patient Safety in Womens Health in recent years. Yet, 
there remains a paucity of data on the appropriate management of non-acute postpartum anemia.  It is 
common practice in obstetrics to offer a transfusion of packed red blood cells (pRBCs) to women with a 
hemoglobin (Hb) value less than 7 g/dL (hematocrit less than 20%) and to symptomatic women with 
even higher hemoglobin levels. Although transfusions were historically initiated with 2 units of pRBCs, 
the most recent recommendation from the American Association of Blood Banks (AABB) for a stable 
patient is to begin with 1 unit and reassess. However, while surgical data has successfully demonstrated 
that liberal blood transfusion increases morbidity and mortality in comparison to restricted transfusion, 
no randomized controlled trials have been performed in obstetrics to demonstrate superiority of a 
single-unit transfusion protocol.  We propose a randomized, controlled trial in non-acute postpartum 
anemia comparing single-unit versus multiple-unit transfusion by total numbers of units transfused and 
maternal morbidity with the hypothesis that single-unit transfusions can reduce the number of units 
transfused without increasing maternal morbidity.
Objectives
Overall objectives
We propose a randomized, controlled trial in non-acute postpartum anemia comparing single-unit 
versus multiple-unit transfusion by total numbers of units transfused and maternal morbidities.
Primary outcome variable(s)
To determine if a single-unit pRBC transfusion protocol in non-acute postpartum anemia can reduce 
total number of units transfused compared to a multiple-unit pRBC transfusion protocol.
Secondary outcome variable(s)
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in 
maternal morbidity, including postpartum infections, length of stay, and transfusion reactions. To 
determine if there is a difference between single-unit and multiple-unit transfusion protocols in 
breastfeeding rates at hospital discharge and 6 weeks postpartum. To determine if there is a difference 
between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale, 
Multidimensional Fatigue Inventory, and Maternal Attachment Inventory score at 6 weeks postpartum.

Page 7 of 15
Background
Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most 
important cause of maternal morbidity and mortality across the globe (1) and is a focus of attention of 
national organizations such as the Council for Patient Safety in Womens Health in recent years. Yet, 
there remains a paucity of data on the appropriate management of non-acute postpartum anemia. 
Packed red blood cells (pRBC) transfusion may be a lifesaving treatment for acute hemorrhage, but it is 
also widely used after PPH for non-acute, stable anemia (2). Postpartum anemia is associated with 
clinical consequences including fatigue and symptoms of depression (3,4). A low postpartum 
hemoglobin (Hb) is the most important commonly cited reason to prescribe RBC transfusions (5). The 
indication for RBC transfusion, however, is not to increase postpartum Hb level, but to reduce 
morbidity and improve the health-related quality of life. It is common practice in obstetrics to offer a 
transfusion of pRBCs to women with a Hb value less than 7 g/dL (hematocrit less than 20%) and to 
symptomatic women with even higher hemoglobin levels (2). Transfusions were historically initiated 
with 2 units of pRBCs, and this remains the case on many labor and delivery units across the country, 
including at the Hospital of the University of Pennsylvania. However, there is increasing concern about 
adverse effects and costs of current transfusion practice. The most recent recommendation from the 
American Association of Blood Banks (AABB) for a stable patient is to begin with 1 unit and reassess 
(6). The American College of Obstetricians and Gynecologists, in the newly released 2017 practice 
bulletin on postpartum hemorrhage, has included the AABBs statement, endorsing the use of single-unit 
transfusion (7). While surgical data has successfully demonstrated that liberal blood transfusion 
increases morbidity and mortality in comparison to restricted transfusion (8), no trials have been 
performed in obstetrics to demonstrate superiority of a single-unit transfusion protocol. In addition, a 
qualitative study in Australia looking at provider practice and perception regarding single- versus 
multiple- unit transfusion protocols after a similar national recommendation demonstrated wide 
variation. To some providers, single-unit transfusions had lower perceived utility and multiple-unit 
transfusions were perceived to improve maternal-infant bonding and infectious outcomes. In contrast, 
others believed that single-unit transfusions reduced infection and transfusion reaction risk while having 
the same desired efﬁcacy (9).
Study Design
Phase*
Not applicable
Design
General Design: A randomized, controlled trial in non-acute postpartum anemia comparing single-unit 
versus multiple-unit transfusion by total numbers of units transfused. Allocation to Interventional 
Group: Subjects will be randomized to either single-unit versus multiple-unit transfusion protocols. 
Subjects will be randomized in a one to one fashion and the randomization will take place using a 
computer-generated algorithm.  Study Measures 1. The Edinburgh Postnatal Depression Scale (EPDS) 
is a 10-item self-report scale designed to screen for postnatal depression. It has been validated in large, 
diverse populations over the last 30 years (10-11). The scale can be completed in about 5 minutes and 
has a simple method of scoring. It has a score that ranges from 0 to 30. Mothers will be considered to 
have possible postpartum depression (PPD) when the EPDS score is 11. The cutoff will be set at 11, as 
studies have shown this cutoff to maximize the sensitivity and speciﬁcity in detecting PPD to 100 and 
92 %, respectively (12).  2. The Multidimensional Fatigue Inventory (MFI) evaluates ﬁve dimensions of 
fatigue: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. The 
MFI has previously been evaluated in a postpartum population, where the ﬁndings demonstrated a 
signiﬁcant correlation between hemoglobin and physical fatigue score (13). The MFI consists of 20 
statements for which the participant indicates, on a 5-point scale, the extent to which the particular 
statement applies with regard to aspects of fatigue experienced during the previous days. Higher scores 
indicate a higher degree of fatigue. The minimum clinically relevant difference for the MFI has not 
been established for women in the puerperium. 3. The Maternal Attachment Inventory (MAI) was 
developed to measure maternal affectionate attachment (14). This is the unique, affectionate 
relationship that develops between a woman and her infant. It consists of 26 items, organized into a 
four-point Likert scale. t. The lowest score is 26, and the highest is 104. Higher scores indicate greater 
attachment between mother and baby.  Primary Study Endpoint: The primary study endpoint will be a 
reduction in number of blood products used per person from 1.9 to 1.75 with a SD of 0.5.

Page 8 of 15
Study duration
In order to determine our expected sample size, we assessed our baseline data (15). During this time 
period, the culture at our institution was that if the decision was made to proceed with transfusion, 
generally 2 units of pRBCs were given. Over a 3 month period in 2015, 612 patients delivered, of which 
30 received pRBC transfusions (4.9%). 11 of these transfusions occurred prior to the 12 hour blood 
count, which may indicate a more acute need for transfusion. Some of those patients may have also 
received additional units in the non-acute setting after stabilization and thus would still qualify to 
participate in this study. In the whole group of transfused patients, a total of 74 units of pRBCs were 
transfused, at an average of 2.5 units per person transfused. Excluding those transfused in the ﬁrst 12 
hours postpartum, 36 units of pRBCs were transfused among 19 patients at an average of 1.9 units per 
person transfused (with a standard deviation [SD] of 0.3). Thus, over one year, we would expect to see 
approximately 72 patients requiring non-acute postpartum transfusion. Our expected sample size to 
have 80% power to demonstrate a reduction in number of blood products used per person from 1.9 to 
1.68 with a SD of 0.5, assuming an alpha of 5%, would be 33 patients per group. If 50% of patients 
agreed to participate, we estimate it will take 2 years to achieve this sample size. We then expect it will 
take an additional year to analyze and publish our data.  For each study participant, they will be 
involved in the study from the time of consent until their 4-9 week postpartum visit. In order to reduce 
burden to patients, we plan to combine our postpartum survey instruments with the routine postpartum 
visit.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
Given we expect to enroll approximately 3 patients per month, the overall burden on the research staff 
is minimal. Consent and randomization will be performed by the primary investigators as well as 
trained housestaff who are generally responding to the need for transfusion. 1-2 training sessions will 
occur prior to the beginning of study to adequately train involved housestaff for the consenting process 
and the research protocol. Ongoing educational modules will take place throughout the course of the 
study and additional training sessions will occur to address housestaff turnover.
Characteristics of the Study Population
Target population
We would include nonacute postpartum women (deﬁned as 6 hours after delivery) who have been 
determined to require blood transfusion either by Hb 7g/dL, or 7g/dL with signs or symptoms of 
anemia such as fatigue, dizziness, tachycardia, or hypotension.
Subjects enrolled by Penn Researchers
66
Subjects enrolled by Collaborating Researchers
0
Accrual
We plan to recruit admitted postpartum patients at the time a provider makes the decision that they 
require a nonacute blood transfusion. In order to determine our expected sample size, we assessed our 
baseline data (15). During this time period, the culture at our institution was that if the decision was 
made to proceed with transfusion, generally 2 units of pRBCs were given. Over a 3 month period in 
2015, 612 patients delivered, of which 30 received pRBC transfusions (4.9%). 11 of these transfusions 
occurred prior to the 12 hour blood count, which may indicate a more acute need for transfusion. Some 
of those patients may have also received additional units in the non-acute setting after stabilization and 
thus would still qualify to participate in this study. In the whole group of transfused patients, a total of 
74 units of pRBCs were transfused, at an average of 2.5 units per person transfused. Excluding those 
transfused in the ﬁrst 12 hours postpartum, 36 units of pRBCs were transfused among 19 patients at an 

Page 9 of 15
average of 1.9 units per person transfused (with a standard deviation [SD] of 0.3). Thus, over one year, 
we would expect to see approximately 72 patients requiring non-acute postpartum transfusion. Our 
expected sample size to have 80% power to demonstrate a reduction in number of blood products used 
per person from 1.9 to 1.68 with a SD of 0.5, assuming an alpha of 5%, would be 33 patients per group.
Key inclusion criteria
Women over 18 Willing and stable to give consent  6 hours postpartum from any mode of delivery 
Determined by their physician to require blood transfusion either by: o Hb 7g/dL OR o 7g/dL with any 
sign or symptom of anemia such as fatigue, dizziness, tachycardia, or hypotension Agreed to accept 
blood transfusion No contraindications to blood transfusion
Key exclusion criteria
We plan to exclude: 1. Patients with hemoglobinopathies 2. Patients with an ejection fraction 35% 3. 
Patients presenting with heart rate of greater than 130 bpm and/or blood pressure readings of less than 
80/40 mm Hg. 4. Patients whose clinicians determine that they do not require transfusion. 5. Patients 
whose clinicians determine that they will deﬁnitely require 2 units. 6. Patients who present with 
hemoglobin levels of less than 5g/dL.
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Populations vulnerable to undue inﬂuence or coercion
Informed consent will be obtained without coercion and all patients approached will be treated equally. 
The Maternal Child Health Research Program works to ensure that studies do not compete for 
participants and that the patient experience on labor and delivery is not negatively impacted by the 
research agenda. Penn students or employees approached to consent will be informed that their decision 
whether or not to participate will in no way impact their standing at the university.
Subject recruitment
We plan to recruit admitted postpartum patients at the time a provider makes the decision that they 
require a nonacute blood transfusion.  If a provider determines a patient is a candidate for a nonacute 
blood transfusion: Step 1: Provider informs patient of recommendation for pRBC transfusion.  Sample: 
We feel that, given your blood count [and/or symptoms], a blood transfusion will help you feel and heal 
better. However, we dont know whether one or two units is the right amount of blood for a postpartum 
patient and we are currently doing a study here to ﬁgure that out. Would you be willing to speak to our 
coordinator about the study? Step 2: Inform research staff/provider about potential patient, who will 
approach the patient for consent at that time. If she consents, she will be randomized at the same time. 
In order to ensure timely treatment, a time limit for consent and randomization from the time a provider 
deems a patient requires transfusion will be set at 6 hours.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:

Page 10 of 15
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Through the Council for Patient Safety in Womens Health, the primary investigator won a National 
Improvement Challenge Award for work in postpartum hemorrhage. This award totaled $3000 
designated for future work in this realm. We plan to utilize this funding for patient compensation as a 
part of this trial.  Given we ask the patient to return for a study visit to complete survey data, we plan to 
compensate patients for the time and effort involved in participating in this study. We plan to provide 
the patient with $25 on discharge date from delivery hospitalization and $25 at the time of the 4-9 week 
postpartum End of Study Visit once the survey instruments are complete. This will be provided in the 
form of a Visa giftcard.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
See attached document.
The following documents are currently attached to this item:
Procedures (smartbloodprotocolforirbv2.pptx)
Deception
Does your project use deception?
No
International Research
Are you conducting research outside of the United States?
No
Analysis Plan
Baseline and demographic characteristics will be summarized by standard descriptive statistics 
(including mean and standard deviation for continuous variables such as age and standard percentages 
for categorical variables such as gender). We will use T tests to compare number of units transfused 
between our single-unit and multiple-unit transfusion protocols.
The following documents are currently attached to this item:
There are no documents attached for this item.

Page 11 of 15
Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
Information about study subjects will be kept conﬁdential and managed according to the requirements 
of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require 
a signed subject authorization informing the subject of the following:  What protected health 
information (PHI) will be collected from subjects in this study Who will have access to that information 
and why Who will use or disclose that information The rights of a research subject to revoke their 
authorization for use of their PHI.  In the event that a subject revokes authorization to collect or use 
PHI, the investigator, by regulation, retains the ability to use all information collected prior to the 
revocation of subject authorization. For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (i.e. that the subject is alive) 
at the end of their scheduled study period. No subject's identifying information (including but not 
limited to name, birth date, medical record number, address, phone number, email address, social 
security number, or photo identiﬁcation) will be recorded. Instead, each patient will be identiﬁed only 
by a study number. This will be very effective in protecting the identity and other personal information 
of each patient enrolled. Data will be stored on a password protected and institutionally secured 
computer in a locked ofﬁce. Any printed copies will be stored in a locked ﬁle cabinet in a locked ofﬁce. 
The de-identiﬁed data will be used only by those investigators involved in the study. A separate data 
sheet will link the patient's medical record number to her study number. This list will be kept separate 
from the database. This information will be stored in a locked ﬁle cabinet in a locked ofﬁce. The 
principal investigator assures the IRB that this information will not be used after this study without 
prior IRB approval. This list will be discarded after the database is clean and closed. The data will not 
be retained or shared with other researchers. The data will not become a part of the subject's permanent 
record.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 

Page 12 of 15
Potential participants will be identiﬁed by their physician and asked if they would be willing to speak 
with research staff. Only if a patient agrees will they be approached by research staff. Once enrolled in 
the study, the only contact with research staff will be to schedule the postpartum follow up by 
telephone.
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
De-identiﬁed data may be released to statistical support staff if needed.
Data Protection*
x Name
Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
Electronic mail addresses
Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
No
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No

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Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
No
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
No
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject conﬁdentiality will be protected  Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable.
Consent
1. Consent Process
Overview
All subjects for this study will be provided a consent form describing this study providing sufﬁcient 
information for subjects to make an informed decision about their participation in this study. See 
Attachment for a copy of the Subject Informed Consent Form. This consent form will be submitted with 
the protocol for review and approval by the IRB for the study. The formal consent of a subject, using 
the IRB-approved consent form, must be obtained before that subject undergoes any study procedure. 
The subject must sign the consent form, and the investigator-designated research professional obtaining 
the consent. Subjects will be consented by the study Principal Investigators, or appropriate research 
staff, in their postpartum inpatient room. The study will be explained in lay person terms to each 
eligible woman by one of the research staff. The consent form will be given to the woman to review. 
She will have ample time to read the consent form on her own. She will be asked if she has any 
questions regarding the study protocol or the consent form. All questions will be answered. The woman 
will be informed that her care will not be affected if she chooses not to participate in the study and that 
she may discontinue participation in the study at any time point. The consent document will be signed 
by both the research subject and the staff member obtaining consent prior to any research activities.
Children and Adolescents
Not applicable.
Adult Subjects Not Competent to Give Consent
In our population, it is unlikely to approach a patient who would be unable to consent. If a patient is 
unable to provide informed consent as determined by an informal assessment by her provider, she will 
not be eligible for this study.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No

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If no written statement will be provided, please provide justiﬁciation
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt
Potential Study Risks
Given each of these patients has been determined to need a blood transfusion, minimal risk exists in 
receiving single-unit versus multiple-unit protocols. Multiple-unit transfusion is our current standard of 
care. The risk of the single-unit protocol is that the patient may require a prolonged length of stay to 
receive blood more slowly (one unit at a time) as well as slower relief of symptoms. In addition, more 
blood may expose a patient to increased likelihood of infection, reaction, or antibody development.
Potential Study Beneﬁts
It is unclear whether single-unit or multiple-unit transfusion is more beneﬁcial to the patient. Single-
unit transfusion protocol may expose the patient to decreased total units, thereby decreasing the risk of 
transfusion reaction, antigen exposure, and infection via the blood product.  There is a large beneﬁt to 
society in terms of determining whether single-unit transfusion is superior to our current standard of 
care as it could lead to decreased use of a scarce medical resource, donated blood.
Alternatives to Participation (optional)
Outside of the study, it will be provider dependent whether a patient receives 1 or 2 units of blood.
Data and Safety Monitoring
The study PI will be responsible for ensuring the ongoing quality and integrity of the research study. An 
adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. 
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
results in study withdrawal is associated with a serious adverse event is considered by the investigator 
to be of clinical signiﬁcance Need for additional blood products, transfusion reactions, and prolonged 
length of stay will not be considered adverse events as they represent expected issues related to the 
single-unit blood transfusion protocol. We plan to start recording adverse events at the time of 
randomization until the follow up visit. Information on all adverse events will be obtained by review of 
the medical record and recorded immediately in the source document, and also in the appropriate 
adverse event module of the case report form (CRF). The PI will review all adverse events weekly.  All 
adverse events occurring during the study period will be recorded. The clinical course of each event will 
be followed until resolution, stabilization, or until it has been determined that the study intervention or 
participation is not the cause. Serious adverse events that are still ongoing at the end of the study period 
will be followed up to determine the ﬁnal outcome. Any serious adverse event that occurs after the 
study period and is considered to be possibly related to the study intervention or study participation will 
be recorded and reported. The relationship of each adverse event to the study procedures will be 
characterized by the principal investigator as deﬁnitely related, probably related, possibly related, 
unlikely or unrelated. The Investigator will promptly notify the Penn IRB of all on-site unanticipated, 
Adverse Events that are probably or deﬁnitely related to the study procedures. Other unanticipated 
problems related to the research involving risk to subjects or others will also be reported promptly. 
Written reports will be ﬁled using the HS-ERA and in accordance with the Penn IRB timeline of 10 
working days. If an AE has not resolved at the time of the initial report and new information arises that 
changes the investigators assessment of the event, a follow-up report including all relevant new or 
reassessed information (e.g., concomitant medication, medical history) should be submitted to the IRB. 
The investigator is responsible for ensuring that all SAEs are followed until either resolved or stable.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt Assessment
Given each of these patients was already in clinical agreement to receive a blood transfusion, we believe 

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that there is minimal risk in transfusing 1 versus 2 units at a time. We feel that the potential beneﬁt to 
the individual patient and to society outweighs that risk.
General Attachments
The following documents are currently attached to this item:
Informed consent form (smartconsentpostirbeditsfeb152018clean.docx)
Additional forms (smartconsentpostirbeditsfeb152018.docx)
Cover Letter (smartirbresponsesfeb142018.docx)
Questionnaires (smartepds.pdf)
Questionnaires (smartsurveyinstruments4-6weeks.docx)