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

Dr Salaha Azam

Status and phase: Completed; Phase 1

Conditions: Iron Deficiency Anaemia in Childbirth

Treatments: Drug: Iron Polymaltose Complex; Drug: Iron Carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT07384663

206

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Drug: Iron Carboxymaltose

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

Active Comparator group

Description:

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.

Treatment:

Drug: Iron Polymaltose Complex