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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02441439
• Other study ID #: 0036-15
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: November 2022
• 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 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 7, 2022
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Pregnancy

Intervention

Dietary Supplement:
• Iron sucrose 200 mg
I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
• Iron sucrose 500 mg
I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery	Hemoglobin levels will be obtained at the beginning of the study and around delivery	from randomization to delivery
Primary	Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)		The day after delivery
Secondary	Type and rate of adverse events		Up to 30 weeks
Secondary	The rate of patients who discontinued treatment		Up to 30 weeks
Secondary	The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization		Up to 4 weeks
Secondary	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
Secondary	The need for blood transfusion post partum		up to 4 days post partum
Secondary	The need for iron sucrose administration post partum		up to 4 days post partum
Secondary	The rate of anemia associated symptoms		From randomization and up to 30 weeks
Secondary	The levels of neonatal hemoglobin, ferritin and bilirubin		up to 4 days post partum
Secondary	The rate of neonatal polycythemia and need for phototherapy		up to 4 days post partum