Health Condition 1: E611- Iron deficiency
Conditions
Interventions
Intervention1: Intravenous Ferric Carboxymaltose IV-FCM: Intravenous Iron Supplementation
Dose: A single, calculated, high-dose infusion of elemental iron, typically up to 1000 mg(or a dose of 20mg/k
Sponsors
All India Institute of Medical Sciences Patna
Eligibility
Inclusion criteria
Inclusion criteria: Singelton pregnancy with Gestational Age between 14 to 21 weeks and serum ferritin less than 30mcg/dl and Hb greater than 10.5, willing to provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Multiple pregnancy Established Anemia: Haemoglobin less than 10.5g/dl Diagnosis of underlying causes of anemia other than ID,Known Vitamin B12 or Folate deficiency,Confirmed Hemoglobinopathies (e.g., Thalassemia trait, Sickle Cell Disease) Pre-existing, uncontrolled medical conditions that may compromise iron metabolism or fetal outcome (e.g., severe gestational hypertension, pre-eclampsia, active infection, chronic inflammatory disease, or asthma). CRP greater than 5 or presence of urinary or vaginal infections. Presence of any chronic disease or infections- CKD, CLD, Hepatitis History of sensitivity to IV iron, any other severe maternal conditions, refusal of consent. Treated with IV iron, Blood transfusion or erythropoietin 4 weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women developing anemia measured by maternal hemoglobin levels at 36-38 weeks gestation.Timepoint: 4 weeks post-intervention and at 24-28 weeks, 34-36 weeks gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin (Hb) at 4 weeks post intervention, at 28-30 weeks, at 36-38 weeks Change in Serum Ferritin4 weeks post intervention, at 28-30 weeks, at 36-38 weeks Timepoint: 4 weeks post-intervention & 28-30 weeks of gestation & at 34-38 weeks gestation;Overall Incidence of AEs Incidence of Specific GI AEs Frequency of Specific GI AEs Frequency of Non-GI AEs Timepoint: Specific GI AE to be asked & documented at every visit. AE to IV FCM to be monitored during transfusion & to be documented at intervention visit.;Incidence of antepartum haemorrhage Incidence of thromboembolic events Incidence of gestational diabetes mellitus Incidence of gestational hypertensive disorders Timepoint: To be recorded post delivery.;Incidence of prolonged labour Length of labour (in hours) Incidence of oxytocin use Incidence of assisted delivery (e.g., forceps, vacuum) Incidence of unplanned caesarean section Timepoint: To be recorded post delivery;Incidence of blood transfusions (during admission) Incidence of postpartum haemorrhage Maternal blood loss at labour (in mL) Continuous Safety & Mortality Length of maternal hospital admission (in days) ContinuousMaternal death (incidence) Timepoint: To be recorded post delivery;Gestational age (GA) at delivery (in weeks + days) Incidence of preterm birth {GA} less than 37 { weeks Birthweight (in grams) Incidence of low birthweight less than 2,500 g/dl Incidence of intrauterine growth restriction (IUGR) Timepoint: To be recorded post delivery;Incidence of ante- or postnatal asphyxia Incidence of neonatal infection Incidence of neonatal anaemia Incidence of required paediatric assistance Admission to neonatal ward Incidence of congenital malformations Foetal or neonatal death (incidence) Timepoint: To be documented from Neonatology records post delivery. | — |
Countries
India
Contacts
Public ContactDr Ramila Taj
All India Institute of Medical Sciences Patna
Outcome results
None listed