NCT04976179: IVON

Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)

Completed Phase 3 Last updated 21 July 2023

What this trial tests

Phase 3 trial testing Ferric carboxymaltose in Iron Deficiency Anemia of Pregnancy in 1,056 participants. Completed in 15 June 2023.

Timeline

9 August 2021

Primary endpoint
5 April 2023

15 June 2023

Quick facts

Lead sponsor	University of Lagos, Nigeria
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,056
Start date	9 August 2021
Primary completion	5 April 2023
Estimated completion	15 June 2023
Sites	11 locations across Nigeria

Drugs / interventions tested

• Ferric carboxymaltose (FERRIC CARBOXYMALTOSE) — full drug profile →
• Ferrous sulfate — full drug profile →

Conditions studied

• Iron Deficiency Anemia of Pregnancy — all drugs for Iron Deficiency Anemia of Pregnancy →

Sponsor

University of Lagos, Nigeria

Who can join

Adults 15 to 49, female only, with Iron Deficiency Anemia of Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Anaemia in pregnancy is a public health burden with high incidence in Africa. Currently high dose oral iron is recommended for treatment of mild to moderate anaemia and blood transfusion for severe anaemia. The high dose oral iron is often poorly tolerated and associated with several side effects. Various parenteral iron preparations are now available for treatment of iron deficiency anaemia (IDA). The earliest of these, iron dextran is not commonly used because of its potential to cause anaphylactic reactions. Newer preparations have been found to be safer and their use for treatment of IDA is currently being evaluated.

Objective: This study sought out to compare the effectiveness of intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control) for treating IDA in pregnancy and to compare the tolerability, safety and the cost-effectiveness of intravenous versus oral iron among pregnant Nigerian women with moderate and severe IDA at 20-32 weeks' gestation.

Methodology: This study will be a hybrid Type 1 effectiveness-implementation design. 1056 eligible and consenting pregnant women with anaemia at 20 - 32 weeks gestation will be recruited. They will be randomized into either of 2 groups. Group A will have intravenous ferric carboxymaltose 20mg/kg to a maximum of 1000mg in 200mls of normal saline infusion over 15 - 20 minutes at enrolment. Group B will have oral ferrous sulphate 200mg (65mg elemental iron) thrice daily from enrolment till delivery. They will be followed up through delivery and until 6 weeks post partum. Their haemoglobin concentration, full blood count, serum ferritin and serum transferrin will be assayed at specific intervals using standard laboratory techniques. Depression will be assessed at each visit using Edinburg Postnatal Depression Scale. Cost effectiveness analysis will also be done at each visit. The primary outcome measure will be incidence of maternal anaemia and rise in haemoglobin level. Secondary outcome measures will include safety and tolerability of trial drugs, severe maternal events, incidence of infant low birth weight and incidence of depression. Statistical analysis will be done using STATA version 16.0 statistical software (STATACorp, Texas, USA).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial.
   Afolabi BB, Babah OA, Akinajo OR, Adaramoye VO, et al · · 2022 · cited 29× · PMID 36076211 · DOI 10.1186/s13063-022-06690-2
2. Intravenous versus oral iron for anaemia among pregnant women in Nigeria (IVON): an open-label, randomised controlled trial.
   Afolabi BB, Babah OA, Adeyemo TA, Balogun M, et al · · 2024 · cited 21× · PMID 39304237 · DOI 10.1016/s2214-109x(24)00239-0
3. Prevalence of and risk factors for iron deficiency among pregnant women with moderate or severe anaemia in Nigeria: a cross-sectional study.
   Babah OA, Akinajo OR, Beňová L, Hanson C, et al · · 2024 · cited 17× · PMID 38182997 · DOI 10.1186/s12884-023-06169-1
4. Acceptability of IV iron treatment for iron deficiency anaemia in pregnancy in Nigeria: a qualitative study with pregnant women, domestic decision-makers, and health care providers.
   Akinajo OR, Babah OA, Banke-Thomas A, Beňová L, et al · · 2024 · cited 9× · PMID 38347614 · DOI 10.1186/s12978-024-01743-y
5. Effect and safety of intravenous iron compared to oral iron for treatment of iron deficiency anaemia in pregnancy.
   Nicholson L, Axon E, Daru J, Rogozińska E. · · 2024 · cited 5× · PMID 39651609 · DOI 10.1002/14651858.cd016136
6. Intravenous iron for anaemia in pregnancy: A quantitative study of acceptability and feasibility of its integration into routine antenatal care practice in Nigeria.
   Akinajo OR, Banke-Thomas A, Annerstedt KS, Beňová L, et al · · 2026 · PMID 41637471 · DOI 10.1371/journal.pone.0328239
7. Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomized hybrid effectiveness-implementation trial
   Afolabi BB, Babah OA, Akinajo OR, Adaramoye VO, et al · · 2022 · DOI 10.21203/rs.3.rs-1808937/v1