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

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-11-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Iron sucrose 200 mg

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

Group Type OTHER

Iron sucrose 200 mg

Intervention Type DIETARY_SUPPLEMENT

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

Iron sucrose 500 mg

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

Group Type ACTIVE_COMPARATOR

Iron sucrose 500 mg

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Iron sucrose 200 mg

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

Intervention Type DIETARY_SUPPLEMENT

Iron sucrose 500 mg

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No