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Completed

NCT Number: NCT07384663

EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY

This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.

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Key information

Conditions

Iron Deficiency Anaemia in Childbirth Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Doctors Hospital and Medical Centre Lahore

Lahore, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged 18 -45 years;
  • Second trimester (gestational age 14-21 weeks);
  • Females having hemoglobin level of < 11 g/dL

Exclusion criteria

  • Multiple pregnancies,
  • A history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs,
  • Active infections
  • Recent red blood cell (RBC) transfusion
  • Thalassemia minor

Treatment and study plan

Iron Carboxymaltose

Drug

Single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions was administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion.

Iron Polymaltose Complex

Drug

Polysaccharide iron complex 150 mg capsule was administered daily till 4 weeks

Primary outcomes

  1. Blood Haemoglobin Levels

    Time frame: 4 weeks

    Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week

Sponsors and collaborators

Lead sponsor

Dr Salaha Azam

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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