Iron Deficiency Anaemia in Childbirth
Conditions
Keywords
Anaemia, Iron Supplementation, Pregnancy
Brief summary
This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.
Interventions
Single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is \< 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions was administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion.
Polysaccharide iron complex 150 mg capsule was administered daily till 4 weeks
Sponsors
Dr Salaha Azam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women aged 18 -45 years; * Second trimester (gestational age 14-21 weeks); * Females having hemoglobin level of \< 11 g/dL
Exclusion criteria
* Multiple pregnancies, * A history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs, * Active infections * Recent red blood cell (RBC) transfusion * Thalassemia minor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Haemoglobin Levels | 4 weeks | Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week |
Countries
Pakistan
Outcome results
None listed