Postoperative Anaemia
Conditions
Keywords
postoperative, anemia, gynaecologic, surgery
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.
Interventions
DRUGFerinject
DRUGFerrous fumarate
DRUGPlacebo for ferrous fumarate
DRUGPlacebo for ferinject
Sponsors
Vifor Pharma
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 3 weeks postoperative | Serum hemoglobin level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin | 3 weeks postoperative | Serum levels of ferritin |
| Serum Hepcidin | 3 weeks postoperative | Serum hepcidin level |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferinject Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate | 8 |
| Ferrous Fumarate 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
Placebo for ferinject | 9 |
| 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
Placebo for ferrous fumarate
Placebo for ferinject | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Excluded after protocol amendment | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Ferrous Fumarate | Placebo Infusion and Tablets | Ferinject |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 9 Participants | 6 Participants | 8 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Netherlands | 23 participants | 9 participants | 6 participants | 8 participants |
| Sex: Female, Male Female | 23 Participants | 9 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 0 / 8 |
Outcome results
Primary
Hemoglobin
Serum hemoglobin level
Time frame: 3 weeks postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ferinject | Hemoglobin | 8.4 mmol/L |
| Ferrous Fumarate | Hemoglobin | 7.9 mmol/L |
| Placebo Infusion and Tablets | Hemoglobin | 7.1 mmol/L |
Secondary
Serum Ferritin
Serum levels of ferritin
Time frame: 3 weeks postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ferinject | Serum Ferritin | 422 microgram/L |
| Ferrous Fumarate | Serum Ferritin | 57 microgram/L |
| Placebo Infusion and Tablets | Serum Ferritin | 37 microgram/L |
Secondary
Serum Hepcidin
Serum hepcidin level
Time frame: 3 weeks postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ferinject | Serum Hepcidin | 11.6 nmol/L |
| Ferrous Fumarate | Serum Hepcidin | 2.2 nmol/L |
| Placebo Infusion and Tablets | Serum Hepcidin | 1.7 nmol/L |