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

Summary

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).

Conditions

• Iron Deficiency Anemia of Pregnancy

Interventions

DRUG

Ferric carboxymaltose

Ferric carboxymaltose to be given as an intravenous infusion

DRUG

Ferrous sulfate

Ferrous sulphate tablet to be taken orally

Sponsors & Collaborators

• Aminu Kano Teaching Hospital

  collaborator OTHER

• University of Lagos, Nigeria

  lead OTHER

Principal Investigators

• Bosede B Afolabi, DM(Notts) · College of Medicine, University of Lagos, Idi-araba, Nigeria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-08-09

Primary Completion

2023-04-05

Completion

2023-06-15

Countries

• Nigeria

Study Locations