The Use of Iron Therapy for Patients With Anemia After Caesarean Section

Study Overview
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Brief Summary
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The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.

Detailed Description
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Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis. The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.

Official Title
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The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial

Conditions
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Postoperative Anaemia

Intervention / Treatment
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* Drug: Ferinject
* Drug: Ferrous fumarate
* Drug: Placebo for ferrous fumarate
* Drug: Placebo for ferinject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gynecological surgery Hb 5-7 mmol/L Exclusion Criteria: Pregnancy Oncological operations Infections (PID) Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization, Small vulvar / vaginal operations such as (cysts, labia correction) Endometrial ablation Legal incapacity The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery Hematologic disorders Erythropoiesis-stimulating agents &lt; 3months ago Myelosuppressive therapy in history Hepatitis HIV Alcohol abuses Not understanding Dutch Allergic reaction to iron therapy in past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferinject<br>Once an infusion of Ferinject 1000 mg, 1 day after surgery | Drug: Ferinject<br> <br> * Other names: ferric carboxymaltose;Drug: Placebo for ferrous fumarate<br> <br> * Other names: Placebo tablets;|
| Active Comparator: Ferrous fumarate<br>2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery | Drug: Ferrous fumarate<br> <br> * Other names: Iron (II) fumarate;Drug: Placebo for ferinject<br> <br> * Other names: NaCl;|
| Placebo Comparator: Placebo infusion and tablets<br>Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery | Drug: Placebo for ferrous fumarate<br> <br> * Other names: Placebo tablets;Drug: Placebo for ferinject<br> <br> * Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Serum hemoglobin level | 3 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Ferritin | Serum levels of ferritin | 3 weeks postoperative | 
| Serum Hepcidin | Serum hepcidin level | 3 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, anemia, gynaecologic, surgery