Trial Outcomes & Findings for Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia (NCT NCT05047211)
NCT ID: NCT05047211
Last Updated: 2023-08-29
Results Overview
hemoglobin in grams per deciliters
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
6 weeks after delivery
Results posted on
2023-08-29
Participant Flow
Participant milestones
| Measure |
Oral Iron Group
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Oral Iron Group
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Iron Group
n=20 Participants
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
n=20 Participants
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=20 Participants
|
31 years
n=20 Participants
|
27 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after deliveryhemoglobin in grams per deciliters
Outcome measures
| Measure |
Oral Iron Group
n=12 Participants
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
n=15 Participants
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
|---|---|---|
|
Hemoglobin Level
|
12 grams/deciliters
Interval 10.0 to 13.0
|
12 grams/deciliters
Interval 11.0 to 14.0
|
SECONDARY outcome
Timeframe: up to 6 weeks after deliveryfeeling sick to vomit or vomit
Outcome measures
| Measure |
Oral Iron Group
n=19 Participants
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
n=17 Participants
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
|---|---|---|
|
Number of Participants With Nausea or Vomiting
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeks after deliveryGeneralized muscle pain
Outcome measures
| Measure |
Oral Iron Group
n=19 Participants
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day
|
IV Iron Group
n=17 Participants
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion
|
|---|---|---|
|
Myalgia
|
1 Participants
|
0 Participants
|
Adverse Events
Oral Iron Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Iron Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place