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NCT03438227 · ClinicalTrials.gov registry record · Phase 4
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT03438227: Completed Phase 4 study, sponsored by Indiana University.
NCT03438227 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03438227, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. While treatment of iron-deficiency anemia with iron supplementation is recommended, treatment strategies remain controversial: the American College of Obstetrics and Gynecology recommends oral iron supplementation with parental iron reserved for the rare patient who cannot tolerate or will not take oral iron, while United Kingdom professional organizations recommend a more liberal use of parenteral iron. The reason for these disparate recommendations is that few high-quality studies comparing oral to parenteral iron have been conducted in developed countries, and the potential impact of parental iron treatment on obstetric and perinatal outcomes remains unclear. We propose the first randomized-controlled trial in the United States describing the effectiveness and safety of treating pregnant women with iron-deficiency anemia with a protocol including parenteral iron compared with a protocol based on oral iron.
Primary Outcome
Number of participants with maternal hemoglobin \<11g/dl at delivery
Interventions
- DRUG Ferrous sulfate 325mg
- DRUG Iron dextran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-04-15 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 4 |
What the finished NCT03438227 record still lists
NCT03438227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Ferrous sulfate 325mg is the first listed.
NCT03438227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03438227 about?
NCT03438227 is a clinical study titled "Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial". Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. While treatment of iron-deficiency anemia with iron supplementation is recommended, treatment strategies remain controversial: the American College of Ob...
What is the current status of trial NCT03438227?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2018-04-15. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03438227?
The interventions under investigation include: Ferrous sulfate 325mg (DRUG), Iron dextran (DRUG).
Who is sponsoring clinical trial NCT03438227?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03438227's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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