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Figure 1 | Trials

Figure 1

From: Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial

Figure 1

Trial flow. Women with postpartum haemorrhage ≥700 and ≤1,000 mL or PPH >1,000 mL and haemoglobin >6.5 g/dL (4.0 mmol/L) within 48 hours of delivery will be screened for inclusion and exclusion and asked for consent to participate. Baseline questionnaires are completed and blood samples are taken. The participants are randomised to either intravenous iron isomaltoside 1000 or standard medical care. Follow-up visits with completion of questionnaires, blood samples and maternal milk samples are performed at three days, and one, three, eight and 12 weeks after intervention. (EPDS: Edinburgh Postnatal Depression Scale; Hb: haemoglobin; HELLP: haemolysis, elevated liver enzymes, and low platelet count; MFI: Multidimensional Fatigue Inventory; PPH: postpartum haemorrhage; PPQ: Postpartum Questionnaire; RBC: red blood cells; subMFI: subscale of the Multidimensional Fatigue Inventory; subPPQ: subscale of the Postpartum Questionnaire).

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Trials

ISSN: 1745-6215