NCT02038023

Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women

Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Auerbach Hematology Oncology Associates P C · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

Detailed description

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron. To evaluate the safety of IV low molecular weight iron dextran in pregnant women. To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Intravaneous iron(low molecular weight iron dextran)	1000 mg of Iron dextran administered over one hour

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2014-01-16
• Last updated: 2018-06-28
• Results posted: 2018-06-28

Locations

1 site across 1 country: United States