Clinical trial NCT02458625: A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia
Official title: A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Anemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
timeFrame: After 6 weeks post partum
Secondary outcomes:
measure: Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum
timeFrame: Up to 6 weeks post partum
measure: The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire
timeFrame: six weeks post partum
measure: Type and rate of adverse events
timeFrame: Up to 6 weeks post partum
measure: The rate of patients who discontinued treatment
timeFrame: Up to 6 weeks post partum
measure: The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum
timeFrame: From randomization to 6 weeks post partum
measure: The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment
timeFrame: Six weeks post partum
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
References:
citation: 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.