Phase 4
Completed N=40
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Anemia, Iron Deficiency · Delivery Complication
Source: ClinicalTrials.gov NCT05047211 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Hemoglobin Level — 12; 12 grams/deciliters
◆ Published Evidence
Emerging
14citations · ~5 / year
Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial.
Summary
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.
Two randomly assigned groups will be compared during the postpartum period:
1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.
IV 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.
2. 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.
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
Linked Publications
-
Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Level |
12; 12 | — |
| SECONDARY Number of Participants With Nausea or Vomiting |
0; 0 | — |
| SECONDARY Myalgia |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Delivery at our institution
- Hemoglobin below 9 g/dl in postpartum day 1
- Singleton gestation
Exclusion Criteria
- Diagnosis of malabsorptive disorder or history of gastric bypass procedure
- Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
- Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
- Patient has received blood transfusion or there is a plan to transfuse
- Lactose intolerance
Data sourced from ClinicalTrials.gov (NCT05047211) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.