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

Comparison of efficacy and safety of intravenous Ferric carboxymaltose (FCM) with oral iron therapy in pregnant women with mild to moderate iron deficiency anemia (IDA) - An Open Labelled Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058784
Enrollment
212
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O251- Malnutrition in pregnancy

Interventions

Intervention1: Intravenous Ferric carboxymaltose: 1000 mg to 2000 mg intravenous in divided doses Control Intervention1: Oral Iron : Oral Iron ( Tab Autrin )100 mg twice daily till delivery

Sponsors

RESEARCH AND ACADEMIC SECTION AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
?Maternal Haemoglobin levels at 6 weeks of drug administration in both groupsTimepoint: 6 weeks of drug administration in both groups—

Secondary

MeasureTime frame
? 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—

Countries

India

Contacts

Public ContactDr. Shubha Sonam

AIIMS New Delhi

jbsharma2000@gmail.com9868138205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026