The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb \>7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index \>13. Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb \>11 g/dl at 4 and 6 weeks. Percentage of patients achieving Hb rise \>3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron. Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done. Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks. All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes. FCM was repeated weekly up to calculated dose or maximum of 2500mg.
ESI-PGIMSR, Basaidarapur
Delhi, India
Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.
Time frame: Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
Percentage of women in the parenteral group as compared to oral group who achieved correction of anaemia i.e. Hb \>11gm/dl at 4 and 6 weeks post intervention.
Time frame: Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II
Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of \>3gm/dl at 4 and 6 weeks post intervention.
Time frame: Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II
Women in the parenteral group as compared to oral group who achieved haemoglobin (Hb) rise\>2gm from baseline at 4 week and 6 week post intervention.
Time frame: Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Change in red cell indices and peripheral smear from baseline to 6 weeks
To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.
Time frame: Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
Side effects profile for participants of Group I and II
To record the side effect profile in participants of parenteral and oral group in order to determine safety of the intervention upto 6 weeks post intervention.
Time frame: Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
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