Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

Phase 4

Completed

• Conditions: Iron Deficiency Anemia (IDA); Pregnancy
• Interventions: Drug: Iron Carboxymaltose; Drug: Iron Sucrose Injection

• Registration Number: NCT06911034
• Lead Sponsor: CMH Multan Institute of Medical Sciences

Brief Summary

This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.

The main question it aimed to answer was:

Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.

Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.

* Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.

* Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.

Detailed Description

The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \& B.

Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-30
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 28-34 weeks of gestation
• Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is <10 gm% and serum Ferritin < 30 ng/ml.

Exclusion Criteria

• Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
• serum creatinine level of more than 2.0 mg/dL
• history of allergic reaction to intravenous iron infusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxymaltose	Iron Carboxymaltose	Intravenous infusion
Sucrose	Iron Sucrose Injection	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin	After three weeks of completing parenteral iron therapy	Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin

Secondary Outcome Measures

Name	Time	Method
Ferritin levels	Three weeks after completion of parenteral iron therapy	Post treatment ferritin levels will be done

Trial Locations

Locations (1)

Cmh Multan Institute of Medical Sciences; 🇵🇰 Multan, Punjab, Pakistan