Ensayo clínico aleatorizado para evaluar la efectividad de dos vías de administración de hierro, oral e intravenosa, en el tratamiento de la anemia ferropénica posparto

Merino, S.; Picado, Amanda López; Hernández, Horta; Mesa, Jeovany Martinez; Lasa, Iñaki Lete; Barandiarán, Felipe Aizpuru

doi:10.1016/j.gine.2011.03.008

Cited by 3 publications

(9 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Characteristics of the included studies are displayed in Table 1 . Postpartum hemoglobin concentration was the primary inclusion criterion for 15 of the studies [ 32 – 37 , 39 , 40 , 42 – 48 ], with the upper threshold for inclusion ranging from Hb < 8 g/dL to < 11 g/dL. These levels included < 8 g/dL [ 39 , 45 , 47 ]; < 8.5 g/dL [ 48 ]; < 9 g/dL [ 33 , 40 ]; < 10 g/dL [ 32 , 35 , 37 , 42 , 44 ]; < 10.5 g/dL [ 34 ], and < 11 g/dL [ 36 , 43 , 46 ].…”

Section: Resultsmentioning

confidence: 99%

“…Postpartum hemoglobin concentration was the primary inclusion criterion for 15 of the studies [ 32 – 37 , 39 , 40 , 42 – 48 ], with the upper threshold for inclusion ranging from Hb < 8 g/dL to < 11 g/dL. These levels included < 8 g/dL [ 39 , 45 , 47 ]; < 8.5 g/dL [ 48 ]; < 9 g/dL [ 33 , 40 ]; < 10 g/dL [ 32 , 35 , 37 , 42 , 44 ]; < 10.5 g/dL [ 34 ], and < 11 g/dL [ 36 , 43 , 46 ]. Other primary inclusion criteria were postpartum hemorrhage [ 12 , 38 , 49 ]; requirement for blood transfusion [ 50 ], and (undefined) postpartum anemia [ 41 ].…”

Section: Resultsmentioning

confidence: 99%

“…Nineteen studies reported a pre-intervention baseline mean or range. These studies included: Hb ≤ 7.0 g/dL [ 39 , 49 , 50 ]; 7.1 − 8.0 g/dL [ 12 , 32 , 33 , 45 , 47 , 48 ]; 8.1–9.0 g/dL [ 35 , 37 , 40 , 42 , 44 ]; 9.1 − 10.0 g/dL [ 34 , 36 , 38 , 46 , 51 ], and ≥ 10.1 g/dL [ 43 ]. The remaining study stratified participants by baseline hemoglobin concentration, with no mean hemoglobin concentration reported [ 41 ].…”

Section: Resultsmentioning

confidence: 99%

“…Of the eighteen studies with IV-iron intervention arms, IV ferric sucrose was the formulation in nine studies [ 32 , 33 , 36 , 37 , 39 , 40 , 45 , 47 , 48 ]; IV ferric carboxymaltose in seven studies [ 32 , 34 , 35 , 42 – 44 , 46 ], and IV-iron isomaltoside in 2 studies [ 38 , 49 ]. The IV-iron formulation was not stated in one study [ 41 ].…”

Section: Resultsmentioning

confidence: 99%

“…The IV-iron formulation was not stated in one study [ 41 ]. Nine studies with IV-iron intervention arms had fixed doses of IV-iron: five studies used 400 mg IV-iron sucrose [ 33 , 36 , 37 , 40 , 47 ]; one of 600 mg IV-iron sucrose [ 48 ]; one of 1000 mg of [ 35 ]; one of 1200 mg of IV-iron Isomaltoside [ 38 ], and one of 1500 mg of IV-iron Isomaltoside [ 49 ]. The dose of IV iron sucrose was unclear in one study [ 45 ].…”

Section: Resultsmentioning

confidence: 99%

See 4 more Smart Citations

Intravenous iron versus blood transfusion for postpartum anemia: a systematic review and meta-analysis

Caljé,

Groom,

Dixon

et al. 2024

Syst Rev

View full text Add to dashboard Cite

Background Intravenous iron (IV-iron) is used as an alternative to, or alongside, red blood cell transfusion (RBC-T) to treat more severe postpartum anemia (PPA), although optimal treatment options remain unclear. No previous systematic reviews have examined IV-iron and RBC-T, including patient-reported outcomes and hematological responses. Methods A systematic review and meta-analysis of randomized trials comparing IV-iron and RBC-T with each other, oral iron, no treatment, and placebo for the treatment of PPA. Key inclusion criteria were PPA (hemoglobin < 12 g/dL) and IV-iron or RBC-T as interventions. Key exclusion criteria were antenatal IV-iron or RBC-T. Fatigue was the primary outcome. Secondary outcomes included hemoglobin and ferritin concentrations, and adverse events. From 27th August 2020 to 26th September 2022, databases, registries, and hand searches identified studies. A fixed-effect meta-analysis was undertaken using RevMan (5.4) software. The quality of the studies and the evidence was assessed using the Cochrane Risk of Bias table, and Grading of Recommendations, Assessment, Development, and Evaluation. This review is registered with the Prospective Register of Systematic Reviews (CRD42020201115). Results Twenty studies and 4196 participants were included: 1834 assigned IV-iron, 1771 assigned oral iron, 330 assigned RBC-T, and 261 assigned non-intervention. Six studies reported the primary outcome of fatigue (1251 participants). Only studies of IV-iron vs. oral iron (15 studies) were available for meta-analysis. Of these, three reported on fatigue using different scales; two were available for meta-analysis. There was a significant reduction in fatigue with IV-iron compared to oral iron (standardized mean difference − 0.40, 95% confidence interval (CI) − 0.62, − 0.18, I2 = 0%). The direction of effect also favored IV-iron for hemoglobin (mean difference (MD) 0.54 g/dL, 95% confidence interval (CI) 0.47, 0.61, I2 = 91%), ferritin, (MD 58.07 mcg/L, 95% CI 55.74, 60.41, I2 = 99%), and total adverse events (risk-ratio 0.63, 95% CI 0.52, 0.77, I2 = 84%). The overall quality of the evidence was low-moderate. Discussion For all outcomes, the evidence for RBC-T, compared to IV-iron, non-intervention, or dose effects of RBC-T is very limited. Further research is needed to determine whether RBC-T or IV-iron for the treatment of PPA is superior for fatigue and hematological outcomes.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Intravenous iron versus blood transfusion for postpartum anemia: a systematic review and meta-analysis

Caljé,

Groom,

Dixon

et al. 2024

Syst Rev

View full text Add to dashboard Cite

show abstract

Single‐dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial

et al. 2017

View full text Add to dashboard Cite

Background and Objectives To evaluate the clinical efficacy of a single-dose intravenous infusion of iron isomaltoside compared with current treatment practice with oral iron measured by physical fatigue in women after postpartum haemorrhage. Materials and MethodsSingle-centre, open-label, randomized controlled trial. Participants received intravenous iron (n = 97) or oral iron (n = 99), and completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and haematological and iron parameters were measured. Primary outcome was the aggregated change in physical fatigue score from baseline to 12 weeks postpartum.Results The difference in physical fatigue score was -0Á97 (95% CI: -1Á65; -0Á28, P = 0Á006) in favour of intravenous iron, but did not meet the predefined difference of 1Á8. Across visits, we found statistically significant differences in fatigue and depression scores, as well as in haematological and iron parameters, all in favour of intravenous iron. There were no serious adverse reactions.Conclusion A single dose of intravenous iron was associated with a statistically significant reduction in aggregated physical fatigue within 12 weeks after postpartum haemorrhage compared to standard medical care with oral iron below the prespecified criteria of clinical superiority. As patient-reported outcomes improved significantly and intravenous iron resulted in a fast hematopoietic response without serious adverse reactions, intravenous iron may be a useful alternative after postpartum haemorrhage if oral iron is not absorbed or tolerated.

show abstract

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

Holm

Thomsen

Nørgaard

et al. 2015

Trials

View full text Add to dashboard Cite

BackgroundPostpartum haemorrhage can lead to iron deficiency with and without anaemia, the clinical consequences of which include physical fatigue. Although oral iron is the standard treatment, it is often associated with gastrointestinal side effects and poor compliance. To date, no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage.Methods/DesignIn a single centre, open-labelled, randomised trial, women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care. Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health (Multidimensional Fatigue Inventory, Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire), at inclusion and at follow-up visits after three days, one week, three weeks, eight weeks, and 12 weeks postpartum. The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum, as measured by a subscale of the Multidimensional Fatigue Inventory. The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority, we set the minimal clinically relevant difference between the mean scores at 1.8, and the assumed standard deviation at 4.2. Hence, 87 participants per treatment group are needed in order to demonstrate superiority; to provide an extra margin for missing data and dropouts, 200 women will be included.DiscussionThe study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage.Trial registrationThis trial is registered with Clinicaltrials.gov (identifier: NCT01895218) on 26 June 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-16-5) contains supplementary material, which is available to authorized users.

show abstract

Ensayo clínico aleatorizado para evaluar la efectividad de dos vías de administración de hierro, oral e intravenosa, en el tratamiento de la anemia ferropénica posparto

Cited by 3 publications

References 29 publications

Intravenous iron versus blood transfusion for postpartum anemia: a systematic review and meta-analysis

Intravenous iron versus blood transfusion for postpartum anemia: a systematic review and meta-analysis

Single‐dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial

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

Contact Info

Product

Resources

About