A Phase 4 interventional study of Ferinject and Ferrous fumarate in Postoperative Anaemia, sponsored by Maastricht University Medical Center. Terminated at 2 sites in Netherlands. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 27 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Drug: Ferinject · Drug: Placebo for ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Drug: Ferrous fumarate · Drug: 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
Drug: Placebo for ferrous fumarate · Drug: Placebo for ferinject
Also known as: intravenous iron, ferric carboxymaltose
Also known as: Oral iron, Iron (II) fumarate
Also known as: Placebo tablets
Also known as: NaCl
Hemoglobin
Serum hemoglobin level
Time frame: 3 weeks postoperative
Serum Ferritin
Serum levels of ferritin
Time frame: 3 weeks postoperative
Serum Hepcidin
Serum hepcidin level
Time frame: 3 weeks postoperative
| Milestone | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets |
|---|---|---|---|
| Started | 9 | 10 | 8 |
| Completed | 8 | 9 | 6 |
| Not completed | 1 | 1 | 2 |
| Withdrew: Excluded after protocol amendment | 1 | 1 | 2 |
Serum hemoglobin level
| mmol/L | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets |
|---|---|---|---|
| Hemoglobin | 8.4 (7.8 to 8.8) | 7.9 (7.4 to 8.0) | 7.1 (7.1 to 7.4) |
Serum levels of ferritin
| microgram/L | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets |
|---|---|---|---|
| Serum Ferritin | 422 (21 to 682) | 57 (29 to 125) | 37 (14 to 80) |
Serum hepcidin level
| nmol/L | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets |
|---|---|---|---|
| Serum Hepcidin | 11.6 (0.5 to 25.7) | 2.2 (0.5 to 5.2) | 1.7 (0.5 to 4.6) |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ferinject | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Ferrous Fumarate | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Placebo Infusion and Tablets | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
A significant number of patients were lost to follow-up: 2 patients Ferinject group, 4 patients Ferrous fumarate group, and 2 patients placebo group. Most likely reason: no complaints in a phase in which attention to the newborn was given priority.
| Age, Categorical(Participants) | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 6 | 23 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets | Total |
|---|---|---|---|---|
| Female | 8 | 9 | 6 | 23 |
| Male | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Ferinject | Ferrous Fumarate | Placebo Infusion and Tablets | Total |
|---|---|---|---|---|
| Netherlands | 8 | 9 | 6 | 23 |
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center