NCT04505514

Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.

Conditions

• Post Partum Hemorrhage
• Anemia

Interventions

Type	Name	Description
DRUG	Iron Isomaltoside 1000	single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
DRUG	Placebo	100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
DRUG	Iberet-Folic-500	once a day dose, to start 5 days after the intervention

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2020-08-10
• Last updated: 2020-08-12

Locations

1 site across 1 country: Malaysia