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

NCT02441439 — Not applicable, Withdrawn, HaEmek Medical Center, Israel

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Registry	NCT02441439
Status	Withdrawn - The investigators decided not to proceed with this study
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Sponsor	HaEmek Medical Center, Israel (Other)
Conditions	Pregnancy
Interventions	Iron sucrose 200 mg, Iron sucrose 500 mg (Dietary supplement)
Dates	start 2022-01-01, primary completion 2022-11-07, completion 2022-11-07, first posted 2015-05-12, last updated 2022-11-08

-Summary

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

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.

+Arms and interventions

Arm	Type	Interventions	Description
Iron sucrose 200 mg	Other	Dietary Supplement: Iron sucrose 200 mg	first arm will be treated with iron sucrose 200 mg 2-3 times a week
Iron sucrose 500 mg	Active comparator	Dietary Supplement: Iron sucrose 500 mg	Second arm will be treated with iron sucrose 500 mg once a week

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 500 mg (Dietary supplement): I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours

+Outcome measures

Primary outcomes

The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery [from randomization to delivery]: Hemoglobin levels will be obtained at the beginning of the study and around delivery
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) [The day after delivery]

Secondary outcomes

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]
The need for iron sucrose administration post partum [up to 4 days post partum]
The rate of anemia associated symptoms [From randomization and up to 30 weeks]
The levels of neonatal hemoglobin, ferritin and bilirubin [up to 4 days post partum]
The rate of neonatal polycythemia and need for phototherapy [up to 4 days post partum]

+Eligibility

Sex: Female, ages: 18 Years to any

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