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Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: Protocol of the ECLIPSES randomized clinical trial - imarina:6387640

URV's Author/s:Aparicio Llopis, Estefania / Aranda Pons, Núria / Arija Val, Maria Victoria / Basora Gallisà, Josep / Canals Bosch, Joan Miquel / Canals Sans, Josefa / Hernández Martínez, Carmen / RIBOT SERRA, BLANCA
Author, as appears in the article.:Arija, V; Fargas, F; March, G; Abajo, S; Basora, J; Canals, J; Ribot, B; Aparicio, E; Serrat, N; Hernández-Martínez, C; Aranda, N
Author's mail:josep.basora@urv.cat
josep.basora@urv.cat
nuria.aranda@urv.cat
nuria.aranda@urv.cat
jmcanals@urv.cat
jmcanals@urv.cat
carmen.hernandez@urv.cat
carmen.hernandez@urv.cat
josep.basora@urv.cat
josefa.canals@urv.cat
josefa.canals@urv.cat
victoria.arija@urv.cat
victoria.arija@urv.cat
Author identifier:0000-0001-9708-747X
0000-0001-9708-747X
0000-0003-1989-2574
0000-0003-1989-2574
0000-0001-6328-8679
0000-0001-6328-8679
0000-0002-6209-9558
0000-0002-6209-9558
0000-0002-1758-0975
0000-0002-1758-0975
Journal publication year:2014-01-18
Publication Type:Journal Publications
ISSN:14712393
APA:Arija, V; Fargas, F; March, G; Abajo, S; Basora, J; Canals, J; Ribot, B; Aparicio, E; Serrat, N; Hernández-Martínez, C; Aranda, N (2014). Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: Protocol of the ECLIPSES randomized clinical trial. BMC Pregnancy and Childbirth, 14(1), 33-. DOI: 10.1186/1471-2393-14-33
Paper original source:BMC Pregnancy and Childbirth. 14 (1): 33-
Abstract:Background: Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. Recommended iron supplementation dose does not preempt anemia in around 20% of the pregnancies, nor the risk of hemoconcentration in 15%. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health.Methods/Design: Design: Randomized Clinical Trial (RCT) triple-blinded. Setting: 10 Primary Care Centers from Catalunya (Spain). Study subjects: 878 non-anemic pregnant women at early gestation stage, and their subsequent newborns. Methods: The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum #1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum #2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. Measurements: In the mother: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. Biochemical measurements include: Hb, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children: ultrasound fetal biometry, anthropometric measurements, and temperament development.Statistical analyses, using the SPSS program for Windows, will include bivariate and multivariate analyses adjusted for variables associated with the relationship under study.Discussion: Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.Trial registration: This clinical trial is registered at http://www.clinicaltrialsregister.eu as EudraCT number 2012-005480-28. © 2014 Arija et al.; licensee BioMed Central Ltd.
Article's DOI:10.1186/1471-2393-14-33
Link to the original source:https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-14-33
Paper version:info:eu-repo/semantics/publishedVersion
licence for use:https://creativecommons.org/licenses/by/3.0/es/
Department:Psicologia
Medicina i Cirurgia
Ciències Mèdiques Bàsiques
Licence document URL:https://repositori.urv.cat/ca/proteccio-de-dades/
Thematic Areas:Surgery
Obstetrics and gynecology
Obstetrics & gynecology
Interdisciplinar
Enfermagem
Biotecnología
Keywords:Young adult
Ultrasonography, prenatal
Temperament
Research design
Pregnancy complications, hematologic
Pregnancy
Membrane proteins
Medication adherence
Life style
Iron
Infant, newborn
Hydrocortisone
Humans
Histocompatibility antigens class i
Hfe protein, human
Hemoglobins
Hemochromatosis protein
Fetal development
Ferritins
Female
Dose-response relationship, drug
Dietary supplements
Diet
C-reactive protein
Birth weight
Anthropometry
Anemia, iron-deficiency
Adult
Entity:Universitat Rovira i Virgili
Record's date:2026-05-09
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