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

NCT02441439 | Withdrawn

• 1 other identifier: 0036-15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (2)

Iron sucrose 200 mg

OTHER

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

Dietary Supplement: Iron sucrose 200 mg

Iron sucrose 500 mg

ACTIVE COMPARATOR

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

Dietary Supplement: Iron sucrose 500 mg

Interventions

Iron sucrose 200 mg DIETARY_SUPPLEMENT

I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes

Iron sucrose 200 mg

Iron sucrose 500 mg DIETARY_SUPPLEMENT

I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours

Iron sucrose 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11