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Does intravenous iron administration in pregnancy change blood vessel and heart function?

Effects of the correction of iron deficiency by iron infusion on cardiovascular function in pregnancy – a pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000173493
Enrollment
15
Registered
2016-02-11
Start date
2016-02-03
Completion date
2017-01-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Lyell McEwin Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026