Comparison between oral and IV iron preparation in pregnant women with iron deficiency anemia

Not Applicable

• Conditions: Health Condition 1: O251- Malnutrition in pregnancy

• Registration Number: CTRI/2023/10/058784
• Lead Sponsor: RESEARCH AND ACADEMIC SECTION AIIMS NEW DELHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Pregnant women aged =18, gestational week =14, =28 at baseline visit

Iron deficiency anaemia (mild to moderate): defined as Hb concentration =7 g/dl and =11 g/dL at screening

Willing to participate: Patients must provide written informed consent for their participation in the study

Exclusion Criteria

Known hypersensitivity to FCM or other IV or oral iron preparations

severe anaemia (Hb less than 7 g/dL)

Blood transfusion, erythropoietin treatment, parenteral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study

Aplastic , haemolytic or drug induced anaemia

Haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases and enzyme defects

Acute or chronic infection

Multiple pregnancies

Evidence on any significant abnormalities on anomaly ultrasound

Haemochromatosis or other iron storage disorders

Known case of chronic kidney disease (CKD), chronic liver disease (CLD), Severe cardiovascular diseases

Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.

Any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study

Participation in any other interventional study since estimated conception and throughout study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?Maternal Haemoglobin levels at 6 weeks of drug administration in both groupsTimepoint: 6 weeks of drug administration in both groups

Secondary Outcome Measures

Name	Time	Method
?Maternal RBC indices (MCV, MCH, MCHC), iron status (measured through iron biomarkers like serum ferritin, TIBC, TSAT, serum iron)Timepoint: 6 weeks and prior to delivery