A prospective study of the effect of two different forms of iron therapy for women, who diagnosed with iron deficiency anaemia during pregnancy with the aim to achieve a normal haemoglobin level at the time of delivery.

A prospective randomised trial to study the effect of intravenous iron therapy versus the standard treatment with oral iron for women diagnosed with iron deficiency anaemia in pregnancy.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000177257

Acronym

Anaemia in pregnancy

Enrollment

200

Registered

2009-04-17

Start date

2007-03-31

Completion date

2009-01-31

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

To date, limited data is available regarding the prevalence of iron deficiency anaemia (IDA) during pregnancy in Australia, or the comparative efficacy of intravenous (IV) iron versus oral iron therapy in pregnant women. Patients and Method: At the Launceston General Hospital we prospectively investigating pregnant women with full blood count (FBC) and iron studies at the first or second antenatal visit. Among those, patients with iron deficiency anaemia, will be recruited to a prospective randomised trial to determine whether intravenous iron therapy (iron polymaltose) is superior to oral iron (ferrous sulphate 250 mg) for the management of IDA associated with pregnancy. Our perliminary data indicate that iron deficiency is a common finding during pregnancy in the northern Tasmanian population, and intravenous iron therapy appears a safe and effective treatment in this cohort of patients.

Interventions

Intravenous iron polymaltose in a dose according body weight once. Iron dose calculated in mg (50 mg per 1 ml)= body weight in kg x (Target haemoglobin (Hb)-actual haemoglobin (Hb) in g/L) x constant factor (0.24) + iron store immediately after randomisation

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

This trial will be available to all women planning confinement at the Launceston General Hospital (LGH) over a period of 18-24 months. Pregnant women who are anaemic with Hb level <116g/L and 18 year old and above are eligible for this study.

Exclusion criteria

Cause of anaemia other than Iron deficiency: Malabsorption syndrome affecting uptake of oral iron Condition associated with iron overload e.g. Haemochromatosis

Outcome results