Clinical Trial: Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia

Brief Summary:

200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).

The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.


Detailed Summary:

The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.

The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.

The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).

Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.

Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.


Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: Haemoglobin concentration [ Time Frame: 6 weeks ]

Original Primary Outcome: Haemoglobin concentration [ Time Frame: One week after inclusion ]

Current Secondary Outcome:

  • Ferritin [ Time Frame: 6 weeks ]
  • Fatigue [ Time Frame: 6 weeks ]
    Fatigue scale
  • Quality of life [ Time Frame: 6 weeks ]
    SF-36
  • Post partum depression [ Time Frame: 6 weeks ]
    Edinburgh Post Partum Depression Scale


Original Secondary Outcome:

  • Ferritin [ Time Frame: 1, 3 and 6 weeks after inclusion ]
  • Hemoglobin [ Time Frame: 3 and 6 weeks after inclusion ]
  • Fatigue score [ Time Frame: 1, 3 and 6 weeks after inclusion ]
  • SF-36 scores [ Time Frame: 1, 3 and 6 weeks after inclusion ]
  • Edinburgh Post Partum Depression Scale [ Time Frame: 1, 3 and 6 weeks after inclusion ]


Information By: Norwegian University of Science and Technology

Dates:
Date Received: June 26, 2009
Date Started: June 2009
Date Completion:
Last Updated: February 15, 2012
Last Verified: February 2012