Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

NCT06911034 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Iron Deficiency Anemia (IDA)
  • Pregnancy

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • CMH Multan Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Nidda Ya Consultant, FCPS · CMH Multan Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-07-31
Completion
2024-09-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911034 on ClinicalTrials.gov