The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ferinject
- Conditions
- Postoperative Anaemia
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Hemoglobin
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Intervention: Ferinject
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Intervention: Placebo for ferrous fumarate
Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Intervention: Ferrous fumarate
Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Intervention: Placebo for ferinject
Placebo infusion and tablets
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
Intervention: Placebo for ferrous fumarate
Placebo infusion and tablets
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
Intervention: Placebo for ferinject
Outcomes
Primary Outcomes
Hemoglobin
Time Frame: 3 weeks postoperative
Serum hemoglobin level
Secondary Outcomes
- Serum Hepcidin(3 weeks postoperative)
- Serum Ferritin(3 weeks postoperative)