A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
Phase: PHASE4
Conditions: Anemia, Iron Deficiency, Delivery Complication
Sponsor: The University of Texas Medical Branch, Galveston

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The University of Texas Medical Branch at Galveston 
Research Protocol # 21-0127 
 
Title: A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of 
Postpartum Anemia (IVIRONMAN) 
 
Principal Investigators: Antonio Saad, MD; George R Saade MD 
 
Funding Sponsor: Departmental 
 
 
1. Introduction and Purpose: 
Postpartum anemia is a major global maternal health problem. In developing countries, postpartum 
anemia affects more than two thirds of women. In the United States, it affects 50% of mothers (1) and 
it has been linked to maternal morbidities such as impaired cognition, depression, and fatigue (2-5). Its 
negative impact on infant-mother bonding and neonatal care (6) has been reported. A major risk factor 
for postpartum anemia is iron deficient anemia in the antepartum period. The latter results from 
physiological changes in pregnancy; total blood volume increases by approximately 50% and red 
blood cell mass increases by 25% (7). The relative increase of blood volume compared to red blood 
cell mass causes a physiological anemia of pregnancy and therefore the hemoglobin and hematocrit 
threshold for diagnosing anemia in pregnancy are different than that of a non-pregnant adult. This 
increase in red blood cell mass, combined with the needs of the fetus, placenta, and normal anticipated 
blood loss from vaginal delivery represent a total additional need of 1,000 mg iron for a pregnancy, 
depleting maternal iron reserve (8-11). Oral iron supplementation is currently the standard of care for 
women with iron deficiency postpartum anemia (12,13). Up to 40% of patients do not tolerate oral iron 
(13), mainly due to gastrointestinal effects, leading to poor compliance and persistent anemia (14).   
Intravenous (IV) iron has advantages that bypass absorption challenges and may lead to faster recovery 
of iron stores and hemoglobin concentrations (11), with a proven safety record (16-17). Despite its 
advantages, IV iron is more costly and needs to be administered under supervision in a hospital or 
outpatient clinical setting. Two major reviews have evaluated the impact of IV iron in the postpartum 
period (18, 19). The first review did not find differences in maternal fatigue or maternal deaths, but did 
not report hematological effects such as postpartum hemoglobin. Four new randomized trials have 
been published comparing IV iron to oral iron therapy (20-23). An updated review of 15 randomized 
control trials (N=2182) concluded that hemoglobin concentrations at 6 weeks postpartum were almost 
1 g/dL higher in women who received IV iron compared to oral iron (19). The safety profile of IV iron 
was also reassuring. Among the 15 trials included, only 2 were from the United States and neither one 
had 6 weeks postpartum hemoglobin as primary outcome. Hence, a large multicenter clinical trial is 
needed to adequately assess the impact of both modalities on hematological effects of postpartum 
anemia. Our aim is to perform a feasibility trial in order to guide a larger definite trial. 
 
 
 
 
Brief Study Design and Rationale 
Patients randomly assigned to 2 groups will be compared: 
1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 
weeks TID.  
1.1 IV placebo in sodium chloride 0.9% 500mL infusion will be given before discharge home 
over 1.5 hour, preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 

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2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 
500mL IV infusion over 1.5 hour, preceded by test dose of 25 mg IV low molecular weight iron 
dextran infusion in 100mL 0.9% sodium chloride. 
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID. 
 
 
The standard of care at UTMB for the detection and treatment of postpartum iron deficiency anemia 
is as follows. All postpartum patients undergo blood draws at their first postpartum day for anemia 
screening. Those patients who are identified as anemic (hemoglobin < 12 g/dL) then receive oral 
iron supplementation. There are many different iron supplements that are used at UTMB to treat 
iron deficiency in pregnancy. These supplements vary in elemental iron content, enteral coatings, 
and supplements combined with vitamins and minerals. The choice of which iron supplement is left 
to the discretion of the provider caring for the patient. Among these choices, ferrous sulfate (325mg, 
with 65mg elemental iron) is very commonly prescribed to UTMB patients and thus is the oral iron 
therapy that will be used for this study. Standard UTMB treatment surveillance includes blood 
draws at the 3 and 6 weeks routine postpartum visits. This study will follow the UTMB standard 
treatment surveillance protocol and thus study participants will have no study specific blood 
collections.  
 
 
Primary outcomes: 
• Postpartum hemoglobin and hematocrit at 6 weeks postpartum visit 
 
Secondary outcomes: 
• Assessment of adverse effects (such as: arthralgia, backache, chills, dizziness, moderate to high 
fever, headache, malaise, myalgia, nausea, and vomiting) 
• Analysis of CBC indices including reticulocyte count, MCV, etc. 
• Iron studies at time of diagnosis (Total Iron binding capacity, Ferritin, serum Iron levels: this 
panel measures the amount of iron used from the body’s stored iron in contrast to reticulocyte 
counts that measures amount of red blood cells the bone marrow is making). 
• Need for transfusion in the peripartum period 
• Postpartum hemoglobin and hematocrit 
• Neonatal weight 
• Postpartum fatigue (multidimensional fatigue inventory (MFI) instrument validated by Smets et 
al.) at 6 weeks visit. 
• Postpartum depression (Edinburgh postnatal depression scale) at 6 weeks visit. 
• Neonatal outcomes such as NICU admission, hyperbilirubinemia, and APGAR scores 
• Relationship of obesity to effectiveness of supplementation in both study arms 
• Drug compliance 
 
Study Risks and Benefits: 
The known risks of IV iron therapy are minimal infusion reactions: nausea, vomiting, chills, headache, 
flushing, constipation, mild arthralgia/myalgia of the chest or flank or facial flushing. All of these 
symptoms routinely abate after therapy, and plasma tryptase levels drawn after the reaction are always 
normal. The symptoms are most likely due to minor reactions to labile plasma iron released with any 
of the formulations. Compared to the side-effects present in the majority of people taking oral 
preparations, such as constipation, metallic taste, gastric cramping and thick green tenacious stool, the 
adverse events with IV iron are minor, infrequent and short-lasting. Another concern is anaphylaxis, it 

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has been reported to be very rare (0.6%) with the new IV iron formulation currently in use. IV iron is 
consequently moving rapidly forward in the treatment paradigm. Published evidence supports a wider 
and earlier role for IV iron in the management of postpartum anemia and raises the question of whether 
it should be frontline therapy in such condition.  
 
2. Concise Summary of Project: 
This trial will be a comparative pragmatic double blinded feasibility randomized controlled trial of 
daily versus IV iron in anemic postpartum patients.  
 
Two randomly assigned groups will be compared during the postpartum period: 
1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 
weeks TID.  
IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge 
home over 1.5 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium 
chloride. 
 
2. IV Iron group:  Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 
500mL IV infusion over 1.5 hour preceded by test dose 25 mg IV low molecular weight iron 
dextran infusion in 100mL 0.9% sodium chloride. 
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID. 
 
 
The number of subjects studied will be 40 at UTMB, we plan to approach and consent up to 40 patients 
to allow for screening failures, early withdrawals, and patients lost to follow-up, and patients who must 
withdraw due to failure of therapy. This number was decided for the aim as a feasibility trial goal. 
Study to last an anticipated length of 1 year. If our sample size is not achieved by that time, we will 
consider the trial as not feasible at UTMB only. This trial will provide important information such as 
eligibility, consent, and outcomes rates on which to base feasibility and sample size calculations for a 
larger definitive trial, as well as how many clinical sites would be needed. 
 
 
3. Study Procedures: 
Patient Population 
The patient population will be selected from obstetric patients who delivered at UTMB health system. 
This population can broadly be divided into patients cared for by one of the UTMB faculty obstetric 
providers and those who receive care through the Regional Maternal and Child Health Program 
(RMCHP). We anticipate that the majority of the patients in this study will be recruited from the 
RMCHP patients. 
 
Locations 
John Sealy hospital will be our recruitment site. Research staff will be present at the location and 
consenting and enrolling will only occur when research staff are present. 
 
Research Team 
The research team (or research staff) will consist of the PI, trained research coordinator, and additional 
staff to be trained and added to the research protocol. All members of the research team will be able to 
screen and consent subjects. The PI will work to ensure that the team is of sufficient size to carry out 
the project. Consenting and enrollment of subjects will only occur when a research team member is 
physically present at the study location. 

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Screening 
All pregnant patients who deliver in our unit undergo a laboratory screen for anemia at the first 
postpartum day as part of the UTMB standard of care while recovering in the hospital. Eligible patients 
(PPD#1 patients with a hemoglobin less than 9 g/dl) will be screened and approached while inhouse 
(detailed under section 8). 
 
The anticipated procedures flow is as follows 
1. Research staff will go to postpartum ward. 
2. Research staff will confirm with provider that possible subjects are appropriate candidates for 
treatment with ferrous sulfate. 
3. Research staff will approach screened patients to obtain consent from possible subjects. 
4. Subjects will be randomized using a computer-generated sequential randomization log with 
group assignment, subject name, and medical record number. 
5. After patient is consented and enrolled, the provider will be notified orders will be placed in 
EPIC by providers with the assistance of the research staff; and a note will be placed in the 
electronic chart indicating that the patient is enrolled in the study. 
6. Subjects will continue to receive standard, routine postpartum care and surveillance of 
postpartum iron anemia.  
a. Research staff and PI will periodically monitor surveillance data by chart review. 
7. During their routine 6 weeks postpartum visit, patient’s hemoglobin level will be obtained 
(standard of care at UTMB). If subjects have a hemoglobin level drawn before the 6 weeks 
visits, such as in the 3 weeks postpartum visit, we will also collect this information. 
8. Research staff will conduct chart review to obtain the data points for the primary and secondary 
outcomes (described in section 1) 
 
 
Additional details 
Our primary outcome as well as secondary outcomes are convenient data points collected in the 
standard treatment and surveillance of postpartum anemia. As such patients will not need any study 
specific venipuncture or visits. The frequency and availability of appointments ensures that any 
symptomatic patient will quickly be seen and evaluated. 
 
Any subject who requires escalation of treatment beyond oral or IV supplementation (blood 
transfusion) will be referred to receive appropriate intervention. These subjects will still be included in 
the intent-to-treat analysis. The routine surveillance of anemic postpartum patients described above 
ensures that any treatment failure will be quickly identified and addressed. 
 
Outcomes 
Our primary outcome will be hemoglobin level at 6 weeks postpartum. Based on the available 
evidence we hypothesize that IV iron supplementation will be superior or at least not inferior to oral 
iron supplementation. Additionally, we aim to assess the secondary outcomes as listed in the 
introduction obtained by chart review. Data to be collected includes population characteristics 
including demographics and data points described in the outcomes listed under the introduction 
obtained by chart review.  
 
4. Disposal and Administration of Drug and Placebo/Drug compliance 

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The intervention drugs (IV/PO Iron and placebo) will be provided by Greenpark Compounding 
Pharmacy and UTMB Investigational Drug Service (IDS). The latter will receive, store and dispense 
the drugs for the study. 
Once a qualified subject is consented and randomized, an order will be entered in Epic. The UTMB 
IDS will be notified to dispense the study drug according to the treatment assignment per study 
protocol. The assigned drug and placebo will be delivered to the nursing unit to be administered by the 
nurse assigned to the subject. The assigned nurse will document the administration in Epic using 
Medication Administration Record (MAR). Any unused study drug will be returned to IDS for 
documentation and disposal. Medications used in this study will not be billed to the subject or her 
insurance company. 
The IDS will dispense the pills in a container/bottle and the subject will be given the bottle and given 
instructions to come to clinic at 6 weeks postpartum to see provider with bottle/container. The supplies 
given will be enough for total treatment of 6 weeks. 
 
The subject will be included in the analysis by intent-to-treat once the assigned pills are dispensed 
from IDS and sequential number posted on the subject specific randomization form. 
 
Drug compliance: subject will be instructed to bring pill container to all clinic visits. The provider will 
document number of pills in the container in order to account for compliance at best in each 
postpartum visit and emphasize compliance. At the end of the treatment period (6 weeks postpartum 
visit), the research team will collect the container and count the returned pills prior to returning it to the 
IDS for reconciliation within 2 weeks of receiving the bottle. Study participation will end at 6 weeks 
postpartum. However, if subject does not come to their scheduled postpartum visits, we will do our 
best to attempt to contact and retrieve drug container up to 10 weeks postpartum. 
 
If subject misses her regular postpartum visit, we will make every effort to contact the subject by 
phone and enquire about the outcomes. 
 
5. Criteria for Inclusion of Subjects: 
• Maternal age ≥ 18 years and < 50 years 
• Delivery at UTMB  
• Hemoglobin below 9 g/dl in postpartum day 1: This population has the highest risk to have 
complications from postpartum anemia, protracted recovery and the most to benefit from IV  
iron (4 studies showed benefit of IV iron at 6 weeks PP in subjects with baseline hemoglobin 
values ranging from 7.4 to 8.1 g/dL.)19 
• Singleton gestation 
 
 
6. Criteria for Exclusion of Subjects: 
• Enrolled in another trial that may affect outcome at the discretion of the PI 
• Diagnosis of malabsorptive disorder or history of gastric bypass procedure 
• Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle 
cell, etc.) 
• Significant cardiovascular disease, including but not limited to myocardial infarction or unstable 
angina within 6 months prior to study inclusion or current history of NYHA Class III or IV 
congestive heart failure 
• Patient has received blood transfusion or there is a plan to transfuse 
• Lactose intolerance 

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7. Sources of Research Material: 
The primary and secondary outcomes for this trial will be obtained from chart review for enrolled 
patients. 
 
8. Recruitment Methods and Consenting Process: 
Patients delivered at UTMB Galveston campus will be screened to identify patients with a hemoglobin below 9 
g/dl in postpartum day 1 who also satisfy the other eligibility criteria. Clinical providers will be educated about 
the trial prior to enrollment. We plan to identify these patients by screening the charts of patients delivered in 
our labor and delivery unit to identify potential subjects. Information to be reviewed as part of the screening 
process will be hemoglobin laboratory data and relevant exclusion and inclusion history. Research staff will 
function as the screeners and will alert providers that their patient is a potential subject. The provider caring for 
that patient will then be informed of the patient’s eligibility. Research staff will work with the provider to ensure 
that the study intervention is appropriate therapy for the patient. If the provider agrees that the study intervention 
is appropriate, the provider will then approach the patient to ascertain interest in participation. If the patient is 
interested, the provider will introduce the research staff to the patient who will then explain the study to the 
patient as part of the consenting process. A screening log will be used to track all subjects approached for the 
study. At the time of consent and randomization, the patient will be educated as to the dosing regimen as well as 
the routine treatment surveillance that will occur. This will be done by the research staff consenting the patient. 
 
Spanish speakers: 
Spanish speaking patients will be screened by use of a Spanish interpreter and all patient study materials will be 
translated into Spanish. 
 
Consenting process: 
Written consent will be obtained in a private room in the hospital postpartum ward by direct person-to-person 
conversation. The PI or a collaborator will be responsible for the informed consent. Subjects will be given the 
time needed in order to fully understand and read the consent forms up to 12 hours. All efforts will be made by 
the research staff to answer all questions the subject has and to ascertain that the subject has the right to refuse to 
participate in the study. The consent form and process will describe that patients will be randomly assigned to 
either the study or control group. Each patient will be informed that participation is completely voluntary and in 
no way will affect the postnatal care they receive. 
 
9. Potential Risks: 
Randomization Risk: 
Since treatment will be randomized, it is possible that one or more of the other treatment groups 
will have more benefit or lower side effects than the other group. 
 
Loss of Confidentiality: 
Any time information is collected, there is a potential risk for loss of confidentiality. Every effort 
will be made to keep the subject’s information confidential; however, this cannot be guaranteed.  
 
Blood Draw Risk: 
Each subject will have two  blood draws collected throughout their participation in the study. Risks of 
taking a blood draw include pain, a bruise at the point where the blood is taken, redness and swelling 
of the vein, and infection. There is a rare risk of fainting. These blood draws are part of the standard of 
care and will not place study subjects at any additional risk. 
IV Placement Risk: 
Each subject will receive IV Iron or placebo based of randomization group. Risks of IV placement 
are possible pain, bruising, and infection at the site of the needle stick where the IV is placed. 
Anxiety (nervousness) may possibly be experienced during the placement of the IV. 

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10. Subject Safety and Data Monitoring: 
The PI and research coordinator will be responsible for monitoring the safety of this study, this will 
occur on a quarterly basis. The monitoring will include participant demographics, expected versus 
actual recruitment rates, summary of any quality assurance or regulatory issues, summary of adverse 
events (AEs) or serious adverse events (SAEs) which may have occurred. AEs and SAEs will be 
reported per IRB policies. 
 
11. Procedures to Maintain Confidentiality: 
Data collection will be identified with a participant ID number. Data will be collected and stored with 
the participant ID code only. The master enrollment log linking subject identifiers with study ID 
numbers will be kept in a password-protected database. Relevant data variables (specified under 
outcomes) will be collected by chart review and placed into an Excel or Access file. These files will 
not contain identifiable information and will be stored in password protected, secured UTMB servers. 
The research coordinator and PI will be available to monitor the data and correct any discrepancies 
based on source documents if needed. 
 
12. Potential Benefits: 
The potential benefits of the study to the intervention group (IV iron) include: 
1. Improved fractional absorption of iron with corresponding improvement of anemia compared 
to standard oral iron replacement therapy 
2. Decreased GI side effects with IV iron 
3. Faster increase in hemoglobin 
 
13. Biostatistics: 
We hypothesize that the IV iron group will have a higher hemoglobin level at 6 weeks postpartum 
compared with the oral group. The primary analysis will be conducted on an intention-to-treat basis. 
Between-group differences in continuous variables will be assessed using Student t test or Man-
Whitney rank sum test and results will be given as mean, standard deviation or median range as 
appropriate. Categorical variables will be assessed using the Pearson chi-square test or Fisher exact test 
as appropriate. For dichotomous endpoints, relative risk (RR) and 95% CI values will be calculated. P 
<0.05 will be considered significant. The analysis will be performed after study completion. 
Based on data from the literature19, we estimate that women who received oral iron will have a mean 6 
week postpartum hemoglobin of 11.2 g/dL with a standard deviation of 1.2. We anticipated that 
women that receive IV Iron will have a postpartum 6 weeks mean hemoglobin of 12.4 g/dL. Using 
calculated effect size, power of 80% and 2-sided alpha of 0.05, we estimate that we will need 38 
(19/group) subjects with complete ascertainment. Accounting for 5% lost to follow up, the final sample 
size would be 40. 
We will be performing a superiority approach. Stata 16 will be used for the statistical analysis. 
t tests - Means: Difference between two independent means (two groups) 
 
Analysis: 
A priori: Compute required sample size  
Input:  
Tail(s)                        = 
Two 
 
 
 
Effect size d                  = 
0.9592329 
 
 
 
α err prob                     = 
0.05 
 
 
 
Power (1-β err prob)           = 
0.8 
 
 
 
Allocation ratio N2/N1         = 
1 
Output:  
Noncentrality parameter δ      = 
2.9565544 

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Critical t                     = 
2.0280940 
 
 
 
Df                             = 
36 
 
 
 
Sample size group 1            = 
19 
 
 
 
Sample size group 2            = 
19 
 
 
 
Total sample size              = 
38 
 
 
 
Actual power                   = 
0.8203999 
 
 
 
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