Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

NCT ID: NCT06911034

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-09-30

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.

Conditions

Iron Deficiency Anemia (IDA); Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboxymaltose

Intravenous infusion

Group Type: EXPERIMENTAL

Iron Carboxymaltose

Intervention Type: DRUG

In ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. 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.

Sucrose

Intravenous infusion

Group Type: ACTIVE_COMPARATOR

Iron Sucrose Injection

Intervention Type: DRUG

Iron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. 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.

Interventions

Iron Carboxymaltose

In ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. 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.

Intervention Type: DRUG

Iron Sucrose Injection

Iron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. 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.

Intervention Type: DRUG

Other Intervention Names

Ferrous Carboxymaltose; sucroferric oxyhydroxide; Iron saccharate

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CMH Multan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kiran Saleem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nidda Ya Consultant, FCPS

Role: STUDY_CHAIR

CMH Multan Institute of Medical Sciences

Locations

Cmh Multan Institute of Medical Sciences

Multan, Punjab Province, Pakistan

Countries

Pakistan

References

Bharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.

Reference Type: BACKGROUND

Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.

Reference Type: BACKGROUND

Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.

Reference Type: BACKGROUND

PMID: 30717690 (View on PubMed)

Other Identifiers

U1111-1319-2291

Identifier Type: -

Identifier Source: org_study_id