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

NCT ID: NCT02458625

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-11-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron sucrose 500 mg

One treatment arm will receive a single dose of I.V iron sucrose 500 mg.

Group Type ACTIVE_COMPARATOR

Iron sucrose 500 mg

Intervention Type DIETARY_SUPPLEMENT

Iron sucrose 500 mg+60 mg Iron bisglycinate

Second treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth.

Group Type ACTIVE_COMPARATOR

Iron sucrose 500 mg

Intervention Type DIETARY_SUPPLEMENT

Iron bisglycinate 60 mg

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Iron sucrose 500 mg

Intervention Type DIETARY_SUPPLEMENT

Iron bisglycinate 60 mg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Women above 18 years old after giving birth

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Zohar Nachum

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23.

Reference Type DERIVED
PMID: 34171389 (View on PubMed)

Other Identifiers

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0133-14

Identifier Type: -

Identifier Source: org_study_id