A clinical trial to compare the rise in hemoglobin and serum ferritin levels after giving either intravenous iron sucrose or oral ferrous ascorbate to anemic pregnant women.
- Conditions
- Iron Deficiency Anemia in pregnancy.
- Registration Number
- CTRI/2010/091/001290
- Lead Sponsor
- Dr Deeba Shafi
- Brief Summary
This study is a randomized experimental study with two arms, comparing the efficacy of intravenous iron sucrose and oral ferrous ascorbate in increasing hemoglobin and serum ferritin levels in pregnant women between 28 and 37 weeks of gestation with hemoglobin between 6 and 10gm/dl.Iron sucrose dose required is calculated as 2.4xweight of the patient x hemoglobin deficit+500.Target hemoglobin set at 12gm/dl.One arm(100 patients) are given iron sucrose intravenously. Other arm(100 patients )are given oral ferrous ascorbate 200mg till 6 weeks. The primary outcome will be increase in hemoglobin from baseline at 2weeks,4 weeks an 6 weeks in both groups. The secondary outcome will be rise in serum ferritin levels at 2 weeks,4weeks and 6weeks in both groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 200
- Pregnant women between 28 and 37 weeks of gestation.
- hemoglobin between 6 and 10gm% iron deficiency anemia.
Anemia from cause other than iron deficiency.Multiple pregnancyHistory of previous blood transfusion.History of hematological disease.Risk of preterm labour.Intolerance to iron derivatives.Recent administration of iron.Current usage of iron supplements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method increase in hemoglobin in g/dl increase in hemoglobin at 2weeks,4 weeks and at 6 weeks.
- Secondary Outcome Measures
Name Time Method Increse in serum ferritin levels from baseline. increase at 2 weeks, 4weeks an at 6 weeks.
Trial Locations
- Locations (1)
K.J.Somaiya Medical College and Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
K.J.Somaiya Medical College and Research Centre🇮🇳Mumbai, MAHARASHTRA, IndiaDr Deeba ShafiPrincipal investigatorsomaiyamedical@hotmail.com