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

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

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Iron sucrose 200 mg; Dietary supplement: Iron sucrose 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Iron sucrose 200 mg; first arm will be treated with iron sucrose 200 mg 2-3 times a week	Dietary supplement: Iron sucrose 200 mg; I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
Active Comparator: Iron sucrose 500 mg; Second arm will be treated with iron sucrose 500 mg once a week	Dietary supplement: Iron sucrose 500 mg; I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron; Ferric Oxide, Saccharated
• Other Study ID Numbers: 0036-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No