To study the effect of using the drug, given as injection ferric carboxymaltose in post delivery patients with low hemoglobin levels.

Recruiting

• Conditions: Anemia complicating pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2025/06/089430
• Lead Sponsor: Dr Samreen Mirza

Brief Summary

TITLE- “MANAGEMENT OF POSTPARTUM ANEMIA WITH INTRAVENOUS FERRIC CARBOXYMALTOSE”

INTRODUCTION-

World Health Organization (WHO) has defined postpartum anemia (PPA) as hemoglobin (Hb) of <10 gm% during the postpartum period. The major causes of PPA are prepartum iron deficiency and anemia in combination with acute blood losses at delivery leading to increased prevalence of tiredness, breathlessness, palpitations and may predispose to puerperal sepsis.

Post-partum anemia (haemoglobin level of less than 10g/dl) is one of the commonest puerperal complications and major cause of maternal morbidity and mortality.(10) There is a strong negative correlation between iron status and depression, stress, cognitive function in mothers during the postpartum period all of which can complicate mother–child interactions.

Iron deficiency is the most common nutritional deficiency globally and is the leading cause of anaemia (WHO, 2017). Oral iron therapy is the preferred treatment modality for correction of iron deficiency anemia because of its low cost and ease of use but it is associated with frequent gastrointestinal side effects, thus leading to poor compliance and may also take longer time to replenish iron stores. Parenteral iron helps in restoring iron stores faster and more effectively than oral iron without gastrointestinal side effects. Hence, postpartum IDA requires prompt intervention and high-quality care.

AIM- To study the management of postpartum anemia with intravenous ferric carboxymaltose.



**OBJECTIVES**-

1.To estimate the efficacy of intravenous ferric carboxy maltose in treatment of postpartum anemia

2.To correlate Hb levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.

**METHOD:**

Women with Hemoglobin (Hb) levels ranging from 7 gm/dL to 9.9gm/dL on day 2 of post-partum period, will be administered Ferric Carboxymaltose (FCM) transfusions tailored to their specific needs based on Ganzoni’s formula. Inj. Ferric Carboxymaltose will be administered over a period of 20 minutes. Hemoglobin levels along with RBC indices and peripheral smear will be meticulously recorded before the initiation of treatment and then again after 1 month & 3 months after the treatment has been concluded, to assess the efficacy of the intervention.

Inj. Ferric carboxymaltose compose of 50mg/ml of elemental iron. Each vial of 20ml constitutes 1000mg of elemental iron. It permits the administration of large doses (maximum of 1000 mg/infusion) in a single and rapid session (30-minute infusion).(1)

Ganzoni’s Formula: Total iron dose = {actual body weight(kg)x [12 - actual Hb (gm/dl)] x 2.4 + iron stores (500mg), is designed to determine the most effective dose of iron for each individual, ensuring both safety and efficacy.

Prior administration of drug, test dose of 3ml will be given slowly intravenously and the patient will be observed for 5-10mins for any anaphylactic reactions to occur.

**Outcome:**

To study the effect of drug for compliance & effectiveness.

To study safety profile of drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-07
• Last Update Posted: 2025-06-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• 1)Women after 2 days of delivery with postpartum anemia 2)Hemoglobin values between 7gm/dl to 10 gm/dl 3)Women who had received blood for severe anemia in post partum period will also be included, if there Hb is below 10gm/dl.
• 4)Women already on oral hematinics will also be considered in the study which will act as adjunct along with Inj.
• Ferric Carboxymaltose.

Exclusion Criteria

• 1)Diagnosed anemia like thalassemia, sickle cell anemia, etc.
• 2)Current treatment with myelosuppressive therapy.
• Bleeding disorders.
• 3)Hypersensitivity to IV iron compounds 4)Chronic liver and kidney disorders.
• 5)Iron overload states, for example, hemosiderosis or hemochromatosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To estimate the efficacy of intravenous ferric carboxy maltose in treatment of postpartum anemia	Hemoglobin levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.
2)To correlate Hb levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.	Hemoglobin levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.

Trial Locations

Locations (1)

D Y PATIL MEDICAL COLLEGE AND HOSPITAL AND RESEARCH CENTRE; 🇮🇳 Kolhapur, MAHARASHTRA, India

D Y PATIL MEDICAL COLLEGE AND HOSPITAL AND RESEARCH CENTRE

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Samreen Mirza

Principal investigator

8425920559

samreenmirza89@gmail.com