Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Recruiting
Phase 3
Interventional Study
Iron Deficiency Anemia
Pregnancy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Women and Infants Hospital of Rhode Island · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Pregnant women between the ages of 18-45
* Singleton gestation
* Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
* At 13-30 weeks gestation
* Plan to deliver at participating hospital
Exclusion Criteria:
* Non-iron-deficiency anemia e.g thalassemia, sickle …
Contacts