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Trial registered on ANZCTR


Registration number
ACTRN12615001370594
Ethics application status
Approved
Date submitted
10/12/2015
Date registered
16/12/2015
Date last updated
8/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous iron versus packed cells in acute post-partum anemia
Scientific title
Intravenous iron polymaltose versus red blood cell transfusion in the management of post-partum anaemia: a prospective randomised trial
Secondary ID [1] 288120 0
Nil known
Universal Trial Number (UTN)
U1111-1177-4669
Trial acronym
IIBAPPA: intravenous iron or blood for acute post-partum anemia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute post-partum anemia following blood loss >1000mL 297001 0
acute post partum anaemia 297056 0
Condition category
Condition code
Reproductive Health and Childbirth 297253 297253 0 0
Childbirth and postnatal care
Blood 297254 297254 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Packed red blood cell transfusion (single or multiple units depending on starting Hb with target level of 9g/dL). Each packed cell transfusion (i.e. 1 unit) contains 260mL of red blood cells leukodepleted with 50g/unit of hemoglobin and a hematocrit of 0.59L/L. Each unit is administered over 4 hours as per routine hospital protocol.
Intervention code [1] 293434 0
Treatment: Other
Comparator / control treatment
Comparator group (directly comparing with intervention i.e. blood): single dose intravenous iron polymaltose (dose calculation based on Ganzoni formula) administered over 4-6 hours.

Control: all women who meet inclusion criteria for the study who refuse to have blood or iron will be included in a control group and will be prescribed 325mg oral ferrous sulphate daily for a period of 4-6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 296860 0
Hemoglobin Level (serum assay)
Timepoint [1] 296860 0
Day 7
Primary outcome [2] 296861 0
C Reactive Protein (serum assay)
Timepoint [2] 296861 0
Day 7
Primary outcome [3] 296862 0
Ferritin (serum assay)
Timepoint [3] 296862 0
Day 7
Secondary outcome [1] 319488 0
Hemoglobin level (serum assay)
Timepoint [1] 319488 0
Day 14, Day 28
Secondary outcome [2] 319489 0
Anemia symptom severity based on results of health related questionnaires designed to specifically evaluate symptoms of anemia (Euro-QoL 5D; MFI 20 scales)
Timepoint [2] 319489 0
Day 0, Day 7, Day 14, Day 28
Secondary outcome [3] 319490 0
Clinical evidence of infection following treatment (i.e. all or any of offensive vaginal discharge, wound discharge and dehiscence, cellulitis, mastitis and fever >38.5)
Timepoint [3] 319490 0
Day 7, Day 14, Day 28
Secondary outcome [4] 319491 0
Impact of anemia on breastfeeding quality using our own hospital designed Post Partum Symptom Score. We hope to validate the scale as part of the study.
Timepoint [4] 319491 0
Day 7, Day 14, Day 28
Secondary outcome [5] 319492 0
Treatment safety (both IV iron and packed red cells) looking at incidence and severity of early adverse reactions including rash, bronchospasm, joint/muscle pain, headache, hypotension, tachycardia, syncope, circulatory collapse, chest pain, temperature, altered conscious state. Early adverse reactions monitored for by nursing staff as per hospital protocol at the time of administration. In the event of any adverse effects developing, nursing staff notify medical staff immediately for patient review. The medical officer than rates the reaction as mild/moderate or severe. Late adverse reactions typically include . urticaria, rash, mild non obstructive respiratory symptoms which are assessed via phone interview on Day 1 and 2 by a clinical midwife specialist.
Timepoint [5] 319492 0
Day 0, 1, 2, 7, 14,28
Secondary outcome [6] 331476 0
Reticulocyte count

This outcome is measured by serum assay.
Timepoint [6] 331476 0
Day 0, Day 7, Day 14, Day 28

Eligibility
Key inclusion criteria
Patients who sustain a primary post-partum haemorrhage in excess of 500mL with a resultant Hb of 5.5-8.0 g/dL within 24 hours of stabilisation and/or have a minimal haemoglobin drop of >3g/dL and are symptomatic (i.e. HR 100-120, dizziness, increased respiratory rate to >/= 25 on minimal exertion or postural drop of BP >10mmHg) will be included.
Minimum age
16 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women outside of specified age brackets or having religious or other beliefs precluding the use of RBC transfusion, high risk co-morbidities necessitating rapid Hb restoration (e.g. cardiac failure, cardiomyopathy, ischemic heart disease, chronic renal failure), known blood malignancy, known significant haemoglobinopathy requiring regular blood transfusion prior to or during pregnancy clinical or laboratory evidence of sepsis (i.e. positive blood culture or intra-partum fever >38.5 degrees)and any contra-indication to intravenous iron polymaltose infusion (i.e. asthmatic, known hypersensitivity to iron polymaltose, chronic polyarthritis, acute renal dysfunction, uncontrolled hyperparathyroidism, infectious hepatitis, iron overload (ferritin >1000) and non-microcytic anaemia). Patients with severe symptoms displaying dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks will also be excluded even if their vital parameters are within study criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealment by central randomization via computer generated lists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by way of a computer generated list. Randomisation will be blocked in a 1:1 ratio for RBC transfusion or IV iron polymaltose. Once allocated a study number, the number will be matched to the computer list and an allocation docket will be printed out to say which treatment the patient will receive. Day of treatment corresponds with study Day 0. Stratification will be applied for mode of delivery. The time interval between randomisation and treatment will be recorded to monitor for treatment delay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
To demonstrate equivalence of RBC transfusion and IV iron polymaltose in restoring Hb levels at Day 7 post treatment with 90% power at the 5% significance level (a=0.025) we calculated that 116 women needed to be recruited to each group. This assumes an acceptable difference of 1g/dL and an expected difference of 0.7g/dL in Hb levels between treatment groups. Acceptable differences in treatment were based on previous studies. To demonstrate superiority of IV iron compared with RBC transfusion in restoring iron stores at Day 7 each primary outcome variable will be tested at the 2.5% significance level in order to maintain an overall global significance of 5%. Sample size calculations to demonstrate superiority with 90% power were based on mean ferritin levels from previous studies. Accounting for a 10% loss to follow up, a total of 250 women will need to be recruited for the study.

Data will be analysed according to the intention to treat principle. Primary outcomes will be analysed using one sided and two group t-tests. Secondary outcomes (i.e. incidence of adverse reactions and symptom scores) will be assessed by calculating rates and 95% confidence intervals. Validity of the PPSS will be determined at the time of analyses and if validated, correlations between subscales and primary outcome measures will be analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4924 0
Westmead Hospital - Westmead
Recruitment hospital [2] 4925 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [3] 4926 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 4927 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 12429 0
2305 - New Lambton
Recruitment postcode(s) [2] 12430 0
2144 - Auburn
Recruitment postcode(s) [3] 12431 0
2148 - Blacktown
Recruitment postcode(s) [4] 12454 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 292536 0
Hospital
Name [1] 292536 0
Westmead Hospital
Address [1] 292536 0
Hawkesbury Road
Westmead
NSW 2145
Country [1] 292536 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital--Department of Obstetrics and Gynecology
Address
Hawkesbury Road
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 291251 0
None
Name [1] 291251 0
None
Address [1] 291251 0
None
Country [1] 291251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294010 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294010 0
Level 2 REN Building
Westmead Hospital
Cnr Darcy and Hawkesbury Road
Westmead
NSW 2145
Ethics committee country [1] 294010 0
Australia
Date submitted for ethics approval [1] 294010 0
03/05/2015
Approval date [1] 294010 0
15/05/2015
Ethics approval number [1] 294010 0

Summary
Brief summary
Acute post partum anaemia is a common complication of pregnancy. It is principally iron deficient and is largely predicted by blood loss >1000mL. Ten percent of women with post partum anaemia develop severe anaemia (haemoglobin Hb<8g/dL) and this is associated with significant lethargy, fatigue and poor concentration which impair women from being able to care for their newborn and place them at increased risk of post natal depression. Current management of hemodynamically stable women with acute post partum anaemia is highly variable. Most clinicians opt to administer multiple red blood cell (RBC) transfusions to correct symptoms and restore Hb. No guideline or consensus exists to inform clinicians exactly when to transfuse women and the inherent risks associated with RBC transfusion, including life threatening adverse reactions, infection and thromboembolism, warrant investigation into alternative therapies. Currently, intravenous iron has been proposed as one alternative therapy to RBC transfusion in selected women though the comparative clinical efficacy and safety of this method has not yet been evaluated.
Our study aims to compare intravenous iron polymaltose with RBC transfusion in women who sustain peri-partum blood loss >1000mL with resultant Hb 5.5-8.9g/dL after stabilisation and are symptomatic for anaemia. The study will employ an open label randomised design and be carried out at Westmead Hospital. Primary outcomes will measure Hb, CRP and ferritin levels at Day 7. Secondary outcome will measure Hb ferritin and CRP levels at Day 14 & 28 as well as improvement in anaemia symptoms as measured by Health Related Quality of Life (HRQoL) questionnaires at the same time points.. Treatment safety will also be compared between the groups by looking at incidence and severity of adverse events including infection.
All women with blood loss >1000mL will be identified by Obstetrix, the mandatory hospital record. Once stabilised, these women will be consented by the study researcher and baseline bloods (Hb, reticulocytes count and ferritin) and symptom data will be collected. Women with resultant Hb 5.5-8.9g/dL who remain clinically stable but symptomatic will then be randomised to receive either RBC or intravenous iron polymaltose All adverse reactions will be recorded during and immediately after treatment and again by telephone at Day 1 and 2. Participants will then be reviewed by a midwife or doctor on Day 7, Day 14 and Day 28 where they will have repeat bloods. repeat symptom scores and clinical assessment for infection. Outcomes between treatment groups will then be compared and statistically analysed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62122 0
Dr Seng Chua
Address 62122 0
Westmead Hospital
Hawkesbury Road
Westmead
NSW 2145
Country 62122 0
Australia
Phone 62122 0
+61414937273
Fax 62122 0
Email 62122 0
drchuasc@gmail.com
Contact person for public queries
Name 62123 0
Dr Sarika Gupta
Address 62123 0
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country 62123 0
Australia
Phone 62123 0
+61457779429
Fax 62123 0
Email 62123 0
sappydoo@gmail.com
Contact person for scientific queries
Name 62124 0
Dr Sarika Gupta
Address 62124 0
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country 62124 0
Australia
Phone 62124 0
+61457779429
Fax 62124 0
Email 62124 0
sappydoo@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results