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

Phase 4

Terminated

• Conditions: Postoperative Anaemia
• Interventions: Drug: Ferinject; Drug: Ferrous fumarate; Drug: Placebo for ferrous fumarate; Drug: Placebo for ferinject

• Registration Number: NCT01975272
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Study Start: 2015-03-02
• Primary Completion: 2018-05-17
• Study Completion: 2018-06-21
• Results First Submitted: 2022-01-27
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Results First Posted: 2022-08-22
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

• Gynecological surgery
• Hb 5-7 mmol/L

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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 < 3months ago
• Myelosuppressive therapy in history
• Hepatitis
• HIV
• Alcohol abuses
• Not understanding Dutch
• Allergic reaction to iron therapy in past

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferinject	Placebo for ferrous fumarate	Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferrous fumarate	Placebo for ferinject	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferinject	Ferinject	Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferrous fumarate	Ferrous fumarate	2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Placebo infusion and tablets	Placebo for ferrous fumarate	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
Placebo infusion and tablets	Placebo for ferinject	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

Primary Outcome Measures

Name	Time	Method
Hemoglobin	3 weeks postoperative	Serum hemoglobin level

Secondary Outcome Measures

Name	Time	Method
Serum Hepcidin	3 weeks postoperative	Serum hepcidin level
Serum Ferritin	3 weeks postoperative	Serum levels of ferritin

Trial Locations

Locations (2)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands

Orbis Medical Centre; 🇳🇱 Sittard, Limburg, Netherlands