Autor según el artículo: Arija V; Fargas F; March G; Abajo S; Basora J; Canals J; Ribot B; Aparicio E; Serrat N; Hernández-Martínez C; Aranda N
Departamento: Psicologia Medicina i Cirurgia Ciències Mèdiques Bàsiques
Autor/es de la URV: Aparicio Llopis, Estefania / Aranda Pons, Núria / Arija Val, Maria Victoria / Basora Gallisa, Josep / Canals Bosch, Joan Miquel / Canals Sans, Josefa / Hernandez Martinez, Carmen / RIBOT SERRA, BLANCA
Resumen: 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.
Áreas temáticas: Surgery Serviço social Saúde coletiva Odontología Obstetrics and gynecology Obstetrics & gynecology Nutrição Medicina iii Medicina ii Medicina i Materiais Matemática / probabilidade e estatística Interdisciplinar Ensino Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Biotecnología Administração pública e de empresas, ciências contábeis e turismo
Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
ISSN: 14712393
Direcció de correo del autor: josep.basora@urv.cat nuria.aranda@urv.cat estefania.aparicio@urv.cat jmcanals@urv.cat carmen.hernandez@urv.cat josep.basora@urv.cat josefa.canals@urv.cat victoria.arija@urv.cat
Identificador del autor: 0000-0001-9708-747X 0000-0003-0542-0015 0000-0003-1989-2574 0000-0001-6328-8679 0000-0002-6209-9558 0000-0002-1758-0975
Fecha de alta del registro: 2024-11-16
Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
Referencia al articulo segun fuente origial: Bmc Pregnancy And Childbirth. 14 (1): 33-
Referencia de l'ítem segons les normes 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
Entidad: Universitat Rovira i Virgili
Año de publicación de la revista: 2014
Tipo de publicación: Journal Publications
Repositori URV