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

Postpartum Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458625
• Other study ID #: 0133-14
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 4, 2020
• Est. primary completion date: June 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Postpartum Anemia

Intervention

Dietary Supplement:
• Iron sucrose 500 mg

• Iron bisglycinate 60 mg

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum		After 6 weeks post partum
Secondary	Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum		Up to 6 weeks post partum
Secondary	The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire		six weeks post partum
Secondary	Type and rate of adverse events		Up to 6 weeks post partum
Secondary	The rate of patients who discontinued treatment		Up to 6 weeks post partum
Secondary	The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum		From randomization to 6 weeks post partum
Secondary	The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment		Six weeks post partum