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

Maastricht University Medical Centre (MUMC)

Status and phase: Terminated; Phase 4

Conditions: Postoperative Anaemia

Treatments: Drug: Placebo for ferrous fumarate; Drug: Ferrous fumarate; Drug: Placebo for ferinject; Drug: Ferinject

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01975272

METC 12-2-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 3 patient groups, including a placebo group

Ferinject

Active Comparator group

Description:

Once an infusion of Ferinject 1000 mg, 1 day after surgery

Treatment:

Drug: Ferinject

Drug: Placebo for ferrous fumarate

Ferrous fumarate

Active Comparator group

Description:

2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery

Treatment:

Drug: Placebo for ferinject

Drug: Ferrous fumarate

Placebo infusion and tablets

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ferinject

Drug: Placebo for ferrous fumarate