ActivePhase 3ACTRN12621000968875

Efficacy and Demonstration of IntraVenous Iron for Anaemia in pregnancy (EDIVA)

Efficacy and Demonstration of IntraVenous Iron for Anaemia in pregnancy in Bangladesh (EDIVA)

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Enrollment

900 participants

Start Date

Oct 20, 2022

Study Type

Interventional

Conditions

Low birthweight Anaemia Prematurity

Summary

Anaemia in pregnancy is a major public health problem globally that has adverse effects on maternal and neonatal health outcomes. The primary cause of anaemia in pregnancy is iron deficiency. In most low- and middle-income countries (LMICs), oral iron supplementation is the primary anaemia treatment and prevention strategy and is provided in routine antenatal care. Despite being policy in many countries, major challenges exist with the consumption coverage of at least 90 iron tablets during pregnancy. Consequently, there has been limited progress in reducing the burden of anaemia among pregnant women in many LMICs, such as Bangladesh. In high-income settings, modern intravenous iron products such as ferric carboxymaltose (FCM) are widely available, providing an opportunity to deliver high doses of iron in a single, short infusion. We hypothesize that in LMICs, intravenous iron formulations like FCM will rapidly cure moderate to severe anaemia in pregnancy, thereby improving maternal and neonatal outcomes. This open label randomized controlled effectiveness trial will assess whether, in Bangladesh, treatment of moderate and severe antenatal anaemia (Hb<10g/dL) with a single dose of intravenous ferric carboxymaltose up to 1000mg improves critical maternal (including anaemia, wellbeing) and neonatal (including birthweight, gestation duration) outcomes and is safe (including adverse events, hypophosphataemia) compared to oral iron (delivered as ferrous sulfate via routine antenatal care mechanisms). The trial will recruit 900 women the Narayanganj District, Bangladesh. Women will be recruited during the second or third trimester and be followed up until 12 months postpartum. These data will define a clinical rationale for developing the infrastructure and economic case for implementing this complex intervention in a LMIC setting.

Eligibility

Sex: Females

Inclusion Criteria6

In their second (13-25 completed weeks) or third trimester (26-32 completed weeks of gestation), dated by Last Menstrual Period.
Moderate to severe anaemia (capillary Hb <10g/dL).
Not known to have a multiple pregnancy.
Expected to deliver the baby inside or within 30 minutes of road transport of the study catchment area.
Have drinking water iron <2mg/L.
Willing to provide written informed consent (if the pregnant woman is <18 years of age, consent will be collected from her guardian, while she will sign an assent form).

Exclusion Criteria11

Women visiting the region temporarily or expecting to travel out of the study site for more than one month over the subsequent 12 months.
Women expecting to deliver their baby outside the study region.
Known to have a diagnosis of thalassemia or other inherited red cell condition.
Known to have a prior allergy to intravenous iron.
Women with high drinking groundwater iron.
Women with severe anaemia requiring an emergency blood transfusion (Hb <5g/dL), or with haemodynamic or acute clinical compromise as judged by a study physician.
Known hypersensitivity to any of the study drugs.
Clinical symptoms of current bacterial/viral infection (e.g.fever).
Any condition requiring urgent hospitalization or serious concomitant illness.
Women in the third trimester of pregnancy currently already enrolled in the second trimester of the EDIVA Activity 2.
Women who have already received a dose of intravenous iron during the current pregnancy

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Interventions

This will be a two-arm (1:1) Phase III open-label superiority individual-randomised controlled trial assessing the effectiveness of the intravenous iron ferric carboxymaltose in reducing maternal anaemia, compared to the standard of care of oral iron supplementation. Women in their second or third trimester of pregnancy will be screened for anaemia and those found to be moderately-severely anaemic (haemoglobin <10g/dL) will be randomized to receive the intervention or the control. Intervention: intravenous iron treatment course administered once during pregnancy. Intravenous ferric carboxymaltose (FCM) 1000 mg total dose for body weight of 50 kg or more, or 20 mg/kg for body weight less than 50 kg, will be given over 15 minutes by a skilled study physician/ medical technologist. For participants receiving the intravenous iron treatment course: the skin will be cleaned with ethanol following standard aseptic procedure, and a sterile cannula will be inserted into the forearm or hand by a skilled study physician/medical technologist, and the cannula will be fixed in place with a sterile Tegaderm or clinical tape. The participant will be monitored over the 15 minutes of the infusion for any adverse events and at 10 minutes into the infusion, she will be asked if she experiences any problems and everything will be recorded. If the participant develops any complications, these will be attended to promptly and treated according to standard clinical management guidelines. The participant will be observed for a further 45 minutes and similarly, any problems experienced will be recorded.