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

Postoperative Anaemia Clinical Trial

— VITAPOP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01975272
• Other study ID #: METC 12-2-018
• Status: Terminated
• Phase: Phase 4
• Start date: March 2, 2015
• Est. completion date: June 21, 2018

Study information

• Verified date: March 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 21, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Postoperative Anaemia

Intervention

Drug:
• Ferinject

• Ferrous fumarate

• Placebo for ferrous fumarate

• Placebo for ferinject

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg
Netherlands	Orbis Medical Centre	Sittard	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Vifor Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Serum hemoglobin level	3 weeks postoperative
Secondary	Serum Ferritin	Serum levels of ferritin	3 weeks postoperative
Secondary	Serum Hepcidin	Serum hepcidin level	3 weeks postoperative