NCT01895218

Treatment of Women After Postpartum Haemorrhage

A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

Conditions

• Postpartum Haemorrhage

Interventions

Type	Name	Description
DRUG	Iron isomaltoside 1000	A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.
OTHER	Standard medical Care	Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-07-10
• Last updated: 2015-04-29

Locations

1 site across 1 country: Denmark