Effectiveness and Safety of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose among patients with postpartum iron deficiency anaemia: A randomized controlled trial.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 159
- Locations
- 1
Study Overview
Brief Summary
- 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.
- 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.
- 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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Females aged between 18-45 years.
- •Haemoglobin is more than or equal to 7 g/dL and less than 11 g/dL in the first 48 hours after delivery.
- •Patient is willing to participate in the study.
Exclusion Criteria
- •Patients with haemolytic anaemia, aplastic anaemia, sickle cell anaemia and macrocytic anaemia.
- •Previous history of allergic reaction to Ferric Carboxymaltose or Iron Sucrose.
- •Patients with history of chronic heavy metal toxicity.
- •Patients suffering from chronic kidney disease.
Investigators
Dr Tarun Kumar
All India Institute of Medical Sciences, Jodhpur