None listed
Conditions
Brief summary
Iron-deficiency anaemia (IDA) affects approximately 1 in 7 Australian pregnant women, and optimal treatment for improving maternal wellbeing and decreasing blood transfusion remains uncertain. An issue with prior randomised trials of IV versus oral iron is lack of patient and clinician blinding to treatment received, so the primary aim of this study is therefore to determine the feasibility and effectiveness of blinding treatment allocation to IV iron or saline placebo infusion. Participants will be pregnant women with iron deficiency anaemia between 26 weeks and 33 weeks gestation, and will either be given IV iron and placebo capsules or iron capsules and placebo IV. It is expected that using an opaque sleeve covering the syringe and giving set when administering IV iron or saline placebo, followed by matching placebo or active iron oral tablets, respectively, is feasible and effective.
Interventions
Women will receive:
1) Intravenous ferric carboxymaltose (FCM) 1000mg on a single occasion following treatment allocation, and daily placebo capsules (composition not yet determined) from IV infusion to birth OR
2) Elemental oral iron capsules 80mg daily from IV infusion to birth and a placebo intravenous saline infusion on a single occasion following treatment allocation.
Both groups will begin capsules on the same day as the IV infusion, which will occur at a time suitable for the woman and t
Women will receive: 1) Intravenous ferric carboxymaltose (FCM) 1000mg on a single occasion following treatment allocation, and daily placebo capsules (composition not yet determined) from IV infusion to birth OR 2) Elemental oral iron capsules 80mg daily from IV infusion to birth and a placebo intravenous saline infusion on a single occasion following treatment allocation. Both groups will begin capsules on the same day as the IV infusion, which will occur at a time suitable for the woman and the hospital. Strategies to monitor adherence to the capsules include a participant medication diary, direct observation by study personnel of pill count at 4 weeks after the IV, and questions in follow-up surveys at 8 weeks post-infusion and 6 weeks post-partum.
Sponsors
Dr Amanda Henry
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant adult women (18 or more years of age) with singleton or twin pregnancy, and mild-moderate iron-deficiency anaemia of pregnancy (Haemoglobin 80-104 g/L and Ferritin <30µg/L) between 26 and 32+6 weeks’ gestation.
Exclusion criteria
Age<18 years, higher-order multiple pregnancy, severe anaemia (haemoglobin <80g/L), anaemia without iron deficiency, known malabsorptive syndromes affecting the uptake of oral iron, contraindication/known hypersensitivity to either oral iron or intravenous iron, already received intravenous iron during this pregnancy or taking 80+mg/day of elemental iron for the last 2 weeks, active severe mental health condition or intellectual disability precluding informed consent, women with active bleeding, women who are likely to give birth in the next 6 weeks, blood transfusion this pregnancy, history of anaemia due to another cause e.g. thalassemia, hypersplenism or haemolytic anaemia or iron overload or disorders in iron utilisation
Outcome results
None listed