Trial Outcomes & Findings for The Use of Iron Therapy for Patients With Anemia After Caesarean Section (NCT NCT01975272)
NCT ID: NCT01975272
Last Updated: 2022-08-22
Results Overview
Serum hemoglobin level
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
3 weeks postoperative
Results posted on
2022-08-22
Participant Flow
Participant milestones
| Measure |
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
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
Placebo for ferrous fumarate
Placebo for ferinject
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
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
Placebo for ferrous fumarate
Placebo for ferinject
|
|---|---|---|---|
|
Overall Study
Excluded after protocol amendment
|
1
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ferinject
n=8 Participants
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
n=9 Participants
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
Placebo for ferinject
|
Placebo Infusion and Tablets
n=6 Participants
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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
23 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
23 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
8 participants
n=8 Participants
|
9 participants
n=9 Participants
|
6 participants
n=6 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 3 weeks postoperativeSerum hemoglobin level
Outcome measures
| Measure |
Ferinject
n=6 Participants
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
n=5 Participants
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
Placebo for ferinject
|
Placebo Infusion and Tablets
n=4 Participants
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
|
|---|---|---|---|
|
Hemoglobin
|
8.4 mmol/L
Interval 7.8 to 8.8
|
7.9 mmol/L
Interval 7.4 to 8.0
|
7.1 mmol/L
Interval 7.1 to 7.4
|
SECONDARY outcome
Timeframe: 3 weeks postoperativeSerum levels of ferritin
Outcome measures
| Measure |
Ferinject
n=6 Participants
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
n=5 Participants
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
Placebo for ferinject
|
Placebo Infusion and Tablets
n=4 Participants
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
|
|---|---|---|---|
|
Serum Ferritin
|
422 microgram/L
Interval 21.0 to 682.0
|
57 microgram/L
Interval 29.0 to 125.0
|
37 microgram/L
Interval 14.0 to 80.0
|
SECONDARY outcome
Timeframe: 3 weeks postoperativeSerum hepcidin level
Outcome measures
| Measure |
Ferinject
n=6 Participants
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Ferinject
Placebo for ferrous fumarate
|
Ferrous Fumarate
n=5 Participants
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Ferrous fumarate
Placebo for ferinject
|
Placebo Infusion and Tablets
n=4 Participants
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
|
|---|---|---|---|
|
Serum Hepcidin
|
11.6 nmol/L
Interval 0.5 to 25.7
|
2.2 nmol/L
Interval 0.5 to 5.2
|
1.7 nmol/L
Interval 0.5 to 4.6
|
Adverse Events
Ferinject
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ferrous Fumarate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Infusion and Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. dr. Roy Kruitwagen
Maastricht University Medical Centre
Phone: 0031-3874764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place