To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

HaEmek Medical Center, Israel

Status: Withdrawn

Conditions: Pregnancy

Treatments: Dietary Supplement: Iron sucrose 500 mg; Dietary Supplement: Iron sucrose 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02441439

0036-15

Details and patient eligibility

About

This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

Full description

Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton pregnancy
• Iron deficiency anemia
• Intolerance or low compliance for oral iron

Exclusion criteria

• Known allergy for iron supplements
• Anemia not due to iron deficiency
• Acute infection
• Liver failure or viral hepatitis
• Thalassemia or hemoglobinopathies
• Asthma
• Multiple pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Iron sucrose 200 mg

Other group

Description:

first arm will be treated with iron sucrose 200 mg 2-3 times a week

Treatment:

Dietary Supplement: Iron sucrose 200 mg

Iron sucrose 500 mg

Active Comparator group

Description:

Second arm will be treated with iron sucrose 500 mg once a week

Treatment:

Dietary Supplement: Iron sucrose 500 mg