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Completed

NCT Number: NCT02458625

A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

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Key information

Conditions

Postpartum Anemia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emek Medical Center

Afula, Israel

About this study

Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women above 18 years old after giving birth
  • Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the exclusion criteria

Exclusion criteria

  • Women who suffer from known allergy for iron supplements
  • Women who suffer from anemia not due to iron deficiency
  • Women who suffer from acute infection
  • Women who suffer from liver failure or viral hepatitis
  • Women who suffer from thalassemia or hemoglobinopathies
  • Women who suffer from renal failure
  • Women who suffer from unbalanced thyroid disorder

Treatment and study plan

Iron sucrose 500 mg

Dietary Supplement

Iron bisglycinate 60 mg

Dietary Supplement

Primary outcomes

  1. The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum

    Time frame: After 6 weeks post partum

Secondary outcomes

  1. Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum

    Time frame: Up to 6 weeks post partum

  2. The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire

    Time frame: six weeks post partum

  3. Type and rate of adverse events

    Time frame: Up to 6 weeks post partum

  4. The rate of patients who discontinued treatment

    Time frame: Up to 6 weeks post partum

  5. The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum

    Time frame: From randomization to 6 weeks post partum

  6. The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment

    Time frame: Six weeks post partum

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2015
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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