Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000173493
Ethics application status
Approved
Date submitted
29/12/2015
Date registered
11/02/2016
Date last updated
11/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does intravenous iron administration in pregnancy change blood vessel and heart function?
Scientific title
Effects of the correction of iron deficiency by iron infusion on cardiovascular function in pregnancy – a pilot study
Secondary ID [1] 288206 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
iron deficiency in pregnancy 297120 0
iron deficiency anaemia in pregnancy 297121 0
Condition category
Condition code
Cardiovascular 297355 297355 0 0
Normal development and function of the cardiovascular system
Blood 297434 297434 0 0
Anaemia
Reproductive Health and Childbirth 297435 297435 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Healthy pregnant women undergoing ferric carboxymaltose (FCM) infusion as per obstetric team. In women > 50kg the current standard approach is a single 1000mg FCM infusion. We will measure cardiac and vascular function in a non-invasive manner within 5 days before infusion and compare with measurements taken 2-4 days and 2 weeks after iron infusion.
Intervention code [1] 293506 0
Not applicable
Comparator / control treatment
Five healthy age- and gestation-matched pregnant women who are not iron deficient and are not scheduled for an iron infusion
Control group
Active

Outcomes
Primary outcome [1] 296911 0
Change in skin microvascular reactivity as assessed by Laser Doppler flowmetry in response to:
1. Iontophoresis of acetylcholine and sodium nitroprusside
2. Local heating
3. Post-occlusive reactive hyperemia
Timepoint [1] 296911 0
In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.
Primary outcome [2] 296991 0
Change in cardiac hemodynamics as measured by USCOM:
1. cardiac output
2. stroke volume
3. total peripheral resistance
4. inotropy index
Timepoint [2] 296991 0
In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.
Secondary outcome [1] 319681 0
Change in central and peripheral vascular function as measured by arteriograph:
1. central and brachial blood pressure
2. pulse wave velocity
3. augmentation index.
Timepoint [1] 319681 0
In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.
Secondary outcome [2] 320542 0
Change in retinal vascular diameter measured using retinal photography:
1. central retinal venular equivalents (CRVE)
2. central retinal arteriolar equivalents (CRAE)
Timepoint [2] 320542 0
In the infusion group baseline measurements will be taken within 1 week prior to iron infusion and will be compared with measurements taken at 2-4 days and 2 weeks post infusion. In the control group measurements will be taken at baseline, then repeated after 1 and 2 weeks.

Eligibility
Key inclusion criteria
28 - 38 weeks of gestation
Singleton pregnancy
Booked for iron infusion with FCM at Lyell McEwin Hospital

Control:
28 - 38 weeks of gestation
Singleton pregnancy
Not iron deficient
Haemoglobin >/= 110 g/L
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Skin condition (e.g. psoriasis) on the location where skin doppler studies would take place
Blood pressure >140/>90mmHg
Preexisting cardiovascular disease
Diabetes Mellitus including gestational diabetes
Depression
Obesity (BMI >30 at booking / prior to pregnancy)
Inability to provide informed consent
Non-English speaking

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous data will be presented as mean +/- standard deviation for normally distributed data, or median [interquartile range, IQR] for non-parametric data. Categorical data will be presented as n (%). Differences between groups will be analysed using the Student’s T-test, Mann Whitney U-test or Fisher’s exact test as appropriate. Correlations will be assessed using Pearson’s Product Moment Correlation. Differences in iontophoresis response curves between groups will be assessed using generalized equalizing equations. A probability value of P<0.05 will be considered statistically significant. No power calculation has been performed for this pilot study. The data collected from this study will provide the basis for future sample size calculations. Data will be analysed using Microsoft Excel (Microsoft Office 2011, Microsoft Corporation, Redmond, WA) and SPSS Statistics 18, Release Version 18.0.3 (SPSS Inc., 2010, Chicago).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/02/2016
Date of last participant enrolment
Anticipated
2/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4990 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 12478 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 292601 0
Hospital
Name [1] 292601 0
Lyell McEwin Hospital
Country [1] 292601 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hospital
Address
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 291318 0
University
Name [1] 291318 0
University of Adelaide
Address [1] 291318 0
The University of Adelaide,
AUSTRALIA SA 5005
Country [1] 291318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294082 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 294082 0
The Queen Elizabeth Hospital
Basil Hetzel Institute DX465101
28 Woodville Road
Woodville SA 5011
Ethics committee country [1] 294082 0
Australia
Date submitted for ethics approval [1] 294082 0
20/10/2015
Approval date [1] 294082 0
10/11/2015
Ethics approval number [1] 294082 0
HREC/15/TQEH/239

Summary
Brief summary
Iron deficiency is a common nutritional deficiency among women of childbearing age. Iron deficiency during the third-trimester of pregnancy is associated with premature birth, foetal growth restriction, stillbirth and infection. Women with iron deficiency are at risk of needing red blood cell transfusion, and having cardiovascular problems like enlarged heart or high blood pressure, reduced immune function, tiredness and depressive episodes.
Iron infusion increases iron levels in the body and reduces the risk of the problems described above, but it remains unclear how the blood vessels and the heart respond to the increased iron levels.
The aim of this study is to find out whether pregnant women with iron-deficiency or iron-deficiency anaemia display impaired heart and blood vessel function, and, whether this improves after iron infusion of ferric carboxymaltose.
We will compare results with a group of age– and gestation-matched healthy pregnant women.
We will make 2 or 3 one-hour appointments for participants to come into the Lyell McEwin Hospital:
First : on the day or week before the iron infusion
Second : two - four days post infusion
(Third : two weeks from the first visit depending on the stage of pregnancy)
4 non-invasive tests will be performed:
Laser Doppler studies — Small probes sit on the skin and measure blood flow through the very small blood vessels. We measure the way the blood vessels dilate when a drug or mild heat is applied to a small area of the skin.
Arteriograph — This is a special blood pressure cuff that also measures how stiff blood vessels are.
USCOM — A small ultrasonic probe rests on the skin surface of the neck and measures heart function using sound waves.
Retinal photograph — We will take a photo of the blood vessels at the back of the eyes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62374 0
A/Prof Bernd Froessler
Address 62374 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA 5112
Country 62374 0
Australia
Phone 62374 0
+61881829806
Fax 62374 0
Email 62374 0
bernd.froessler@health.sa.gov.au
Contact person for public queries
Name 62375 0
A/Prof Bernd Froessler
Address 62375 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA 5112
Country 62375 0
Australia
Phone 62375 0
+61881829806
Fax 62375 0
Email 62375 0
bernd.froessler@health.sa.gov.au
Contact person for scientific queries
Name 62376 0
A/Prof Bernd Froessler
Address 62376 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale, SA 5112
Country 62376 0
Australia
Phone 62376 0
+61881829806
Fax 62376 0
Email 62376 0
bernd.froessler@health.sa.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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