The use of iron administered as an infusion into a vein compared to the use of iron tablets taken by mouth for treating Nigerian women with iron deficiency anaemia during pregnancy (IVON trial)

Intravenous versus oral iron for iron deficiency anemia in pregnant Nigerian women (IVON): an open label, randomized controlled trial (IVON trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202012843695208

Enrollment

1056

Registered

2020-12-08

Start date

2021-01-04

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Haematological Disorders Nutritional, Metabolic, Endocrine Pregnancy and Childbirth Maternal anaemia, preterm birth, maternal depression and low birth weight

Interventions

Intravenous ferric carboxymaltose

Oral ferrous sulphate

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 15 to 49 years old. 2. Gestational age 20- and 32-weeks. 3. Baseline (enrollment) laboratory-confirmed moderate or severe anemia (Hb < 10g/dl).

Exclusion criteria

Exclusion criteria: 1. Medically-confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months 2. Symptomatic anemia with dyspnea or fatigue and a need for urgent correction 3. Concurrent anemia of another cause besides IDA. 4. Clinically-confirmed malabsorption syndrome or hypersensitivity to any form of iron treatment. 5. Preexisting maternal depression or other psychiatric illness 6. History of any immune related illness e.g., SLE, Rheumatoid arthritis. 7. Severe allergic reactions such as severe asthma. 8. Women with known drug allergies

Design outcomes

Primary

Measure	Time frame
1. The comparative effectiveness of treatment with intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control) in reducing the prevalence of maternal anemia at 36 weeks' gestation. 2. Reducing the incidence of preterm birth.	—

Secondary

Measure	Time frame
1. Increase in maternal hemoglobin levels at 4 weeks post-initiation of treatment. 2. The safety and tolerability of intravenous ferric carboxymaltose versus oral ferrous sulphate, including the incidence of hypophosphatemia and severity of maternal adverse effects. 3. Severe maternal events, specifically, haemorrhage, sepsis, shock and the need for blood transfusion. 4. The incidence of low infant birthweight (<2.5 kg), prematurity (<37 weeks’ gestation as dated from the last menstrual period or a first trimester ultrasound scan), stillbirth and neonatal mortality (birth till 28 days of life), and proportion of infants being breastfed at 1, 2 and 4 weeks of life, and receiving BCG, oral polio and hepatitis vaccination in same time period. 5. The incidence of small for gestational age (birthweight less than the 10th percentile for gestational age). 6. Depression linked to emotional well-being of mothers using the validated Edinburgh Postnatal Depression Scale. 7. Prevalence of maternal iron deficiency at 36 weeks gestational age defined as serum ferritin level less than 30ng/mL.	—

Measure

Time frame

1. Increase in maternal hemoglobin levels at 4 weeks post-initiation of treatment. 2. The safety and tolerability of intravenous ferric carboxymaltose versus oral ferrous sulphate, including the incidence of hypophosphatemia and severity of maternal adverse effects. 3. Severe maternal events, specifically, haemorrhage, sepsis, shock and the need for blood transfusion. 4. The incidence of low infant birthweight (<2.5 kg), prematurity (<37 weeks’ gestation as dated from the last menstrual period or a first trimester ultrasound scan), stillbirth and neonatal mortality (birth till 28 days of life), and proportion of infants being breastfed at 1, 2 and 4 weeks of life, and receiving BCG, oral polio and hepatitis vaccination in same time period. 5. The incidence of small for gestational age (birthweight less than the 10th percentile for gestational age). 6. Depression linked to emotional well-being of mothers using the validated Edinburgh Postnatal Depression Scale. 7. Prevalence of maternal iron deficiency at 36 weeks gestational age defined as serum ferritin level less than 30ng/mL.

—

Countries

Nigeria

Contacts

Public ContactOchuwa;Abubakar Babah;Abdulazeez

Senior Lecturer Department of Obstetrics and Gynecology Faculty of Clinical Sciences College of Medicine University of Lagos and Lagos University Teaching Hospital IdiAraba Lagos;Program Manager IVON trial Kano Zone

ochuwab@yahoo.co.uk;aabdulazeez459@gmail.com+2347038090032;+2348036430171

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026