A clinical trial to study the efficacy of three drugs (Oral liposomal iron, Oral ferrous sulphate and Intravenous iron sucrose) in pregnant women between 16-28 weeks of gestation with Moderate anemia.
Phase 4
- Conditions
- Health Condition 1: O269- Pregnancy related conditions, unspecified
- Registration Number
- CTRI/2024/08/071860
- Lead Sponsor
- Aarupadai Veedu medical college and hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Antenatal women between 16 to 28 weeks of gestation.
2) Antenatal women with Hemoglobin level between 7 – 9.9g% (Moderate anemia according to WHO)
3) Women with established iron deficiency anemia
4) Women with no prior history of blood transfusion
Exclusion Criteria
1) Antenatal women belong to First trimester (1-12 weeks of gestation) and more than 32 weeks of gestation
2) Women with medical complications/ Hematological disorders
3) Women with Hemoglobinopathies
4) Liver disorder like jaundice, cirrhosis, or renal failure
5) Antenatal women with Hemoglobin level less than 7g%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in Hemoglobin levels after taking the prescribed or administered drug to the patient over a period of 4 weeks in which we will study the Efficacy of Oral liposomal iron when compared to Oral ferrous sulphate and Intravenous iron sucrose in treatment of moderate anemia in pregnancy.Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method 1) To study the patient’s compliance of oral liposomal iron in treatment of anemia in pregnancy. <br/ ><br>2) To observe the compliance of oral ferrous sulphate in treatment of anemia in pregnancy. <br/ ><br>3) To observe and compare the side effects of oral liposomal iron VS oral ferrous sulphate in treatment of anemia in pregnancy. <br/ ><br>4) To observe the adverse effects of intravenous iron sucrose in treatment of anemia in pregnancy. <br/ ><br>Timepoint: 4 weeks