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

Not Applicable

Withdrawn

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Iron sucrose 500 mg; Dietary Supplement: Iron sucrose 200 mg

• Registration Number: NCT02441439
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2022-01-01
• Status Verified: 2022-11
• Primary Completion: 2022-11-07
• Study Completion: 2022-11-07
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron sucrose 500 mg	Iron sucrose 500 mg	Second arm will be treated with iron sucrose 500 mg once a week
Iron sucrose 200 mg	Iron sucrose 200 mg	first arm will be treated with iron sucrose 200 mg 2-3 times a week

Primary Outcome Measures

Name	Time	Method
The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery	from randomization to delivery	Hemoglobin levels will be obtained at the beginning of the study and around delivery
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)	The day after delivery

Secondary Outcome Measures

Name	Time	Method
Type and rate of adverse events	Up to 30 weeks
The rate of patients who discontinued treatment	Up to 30 weeks
The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization	Up to 4 weeks
The change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from the last dose of iron sucrose to delivery in 3 weeks intervals	Up to 30 weeks
The need for blood transfusion post partum	up to 4 days post partum
The need for iron sucrose administration post partum	up to 4 days post partum
The rate of anemia associated symptoms	From randomization and up to 30 weeks
The levels of neonatal hemoglobin, ferritin and bilirubin	up to 4 days post partum
The rate of neonatal polycythemia and need for phototherapy	up to 4 days post partum