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

NCT07384663 | Completed Phase 1

• 1 other identifier: 206
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anaemia in Childbirth

Keywords

Anaemia; Iron Supplementation; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Blood Haemoglobin Levels

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

  4 weeks

Study Arms (2)

Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose )

ACTIVE COMPARATOR

Treatment was initiated at the baseline visit. After baseline data was collected, women allocated to the IV iron group received a 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 were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma.

Drug: Iron Carboxymaltose

Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex)

ACTIVE COMPARATOR

Women in the oral iron group received polysaccharide iron complex 150 mg capsule till 4 weeks. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma.

Drug: Iron Polymaltose Complex

Interventions

Iron Polymaltose Complex DRUG

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

Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex)

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.

Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose )

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Salaha Azam: lead

Study Sites (1)

Doctors Hospital and Medical Centre Lahore

Lahore, 54000, Pakistan

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; teferrol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)