A Phase 2/3 interventional study of Ferric carboxymaltose and Ferrous sulfate tablets in Anemia, Iron-Deficiency, Puerperal Disorders and Depression, Postpartum, sponsored by Norwegian University of Science and Technology. Terminated at 3 sites in Norway. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2012-02-17.
Sponsored by Norwegian University of Science and Technology · Phase 2/3, Interventional, and Treatment
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.
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Drug: Ferrous sulfate tablets
Intravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given.
Drug: Ferric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Also known as: Ferinject
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Also known as: Duroferon
Haemoglobin concentration
Time frame: 6 weeks
Ferritin
Time frame: 6 weeks
Fatigue
Fatigue scale
Time frame: 6 weeks
Quality of life
SF-36
Time frame: 6 weeks
Post partum depression
Edinburgh Post Partum Depression Scale
Time frame: 6 weeks
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ferric carboxymaltose · Ferrous sulfate
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