Health Condition 1: null- Moderate to Severe Anaemia
Conditions
Interventions
Intervention1: Intravenous administration of Ferric Carboxymaltose (FCM)for correcting iron deficiency anaemia.: FCM is available as 10 ml ampoule containing 500 mg of elemental iron. FCM will be admi
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant women in 16-32 weeks with anemia (Hb levels 5.0- 9.9 g/dl) 2.Those who give written consent and agree to cooperate for all measurements at different time points
Exclusion criteria
Exclusion criteria: 1.Those having renal or hepatic impairment 2.Women having Hb 3.Women having previous history of parenteral iron administration 4.Allergy to iron preparations 5.Known case of thalassemia, sickle cell anaemia or haemolytic anaemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean increase in Hb levels at 2 weeks after administration of FCM.Timepoint: Mean increase in Hb levels at 2 weeks after administration of FCM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events after administration of FCM.Timepoint: at the time of administration, 2 weeks, delivery and 6 months postpartum;Mean increase in Hb levels at delivery and 6 months postpartum.Timepoint: Delivery and 6 months postpartum;Mean increase in Serum Ferritin level at 6 months postpartum.Timepoint: 6 months postpartum;Oxidative stress markers after administration of FCM.Timepoint: 2 weeks, delivery and 6 months post partum | — |
Countries
India
Contacts
Public ContactDr Shashi Kant
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed