Effectiveness and Safety of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose among patients with postpartum iron deficiency anaemia: A randomized controlled trial.

1. Background

Postpartum iron deficiency anaemia is a common condition affecting 50-80 % of mothers in developing countries worldwide, contributing significantly to maternal morbidity and mortality. It is mainly caused due to anaemia in pregnancy, postpartum haemorrhage, and suboptimal iron intake during pregnancy and lactation. It can have adverse effects on both mother and child, leading to impaired mother-child bonding. It can cause chronic fatigue, reduced lactational output and caregiving, increased susceptibility to postpartum depression in mother and impaired neurodevelopmental trajectory in child. This study compares the effectiveness and safety of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose among patients with postpartum iron deficiency anaemia.

2. Materials and Methods

Participants meeting to the eligibility criteria will be recruited from the inpatient department (IPD) of Department of Obstetrics and Gynaecology at AIIMS Jodhpur. This study will involve recording of Complete Blood Count (CBC), Serum Ferritin, safety profile and compliance, EPDS (Edinburgh Postnatal Depression Scale) score, and cost effectiveness in these patients. Subsequently, the safety and effectiveness of the three drugs will be evaluated. The outcomes of the study will be determined based on the assessment at 6th and 10th weeks.

3. Implications

The FOGSI (Federation of Obstetric and Gynaecological Societies in India) consensus recommends universal Hb screening of every postpartum woman prior to discharge for early diagnosis and treatment. The treatment includes ferrous ascorbate tablet and intravenous iron preparations like iron sucrose and FCM, which is given according to severity of anaemia and physician’s discretion. A single dose IV FCM after an informed decision can provide logistical benefit to patient, which is also recommended by FOGSI. However, there is paucity of head-to-head RCTs in postpartum population comparing Ferrous Ascorbate, Iron Sucrose and Ferric Carboxymaltose simultaneously. Therefore, this study is for understanding effectiveness, safety, psychological well-being outcomes, and pharmacoeconomic analysis of the three drugs.