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

Abstract

BackgroundCurrently, 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/DesignDesign: Randomized Clinical Trial (RCT) triple-blindedSetting: 10 Primary Care Centers from Catalunya (Spain)Study subjects: 878 non-anemic pregnant women at early gestation stage, and their subsequent newbornsMethods: 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.DiscussionShould 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 registrationThis clinical trial is registered at http://www.clinicaltrialsregister.eu as EudraCT number 2012-005480-28

Association of Iron Status and Intake During Pregnancy with Neuropsychological Outcomes in Children Aged 7 Years: The Prospective Birth Cohort Infancia y Medio Ambiente (INMA) Study

“…Previous studies with animal models suggest that early-life ID could have long-lasting effects on cognitive function independently of receiving an iron-normal diet later in life [61]. The small sample size in this subgroup of women makes it difficult to confirm this interpretation [62].…”

Effect of Vitamin D Status during Pregnancy on Infant Neurodevelopment: The ECLIPSES Study

“…The ECLIPSES study [ 17 ] was a community randomized controlled trial (RCT) conducted in the province of Tarragona (Catalonia, Spain) between 2013 and 2017. The 793 participants (mean age 30.6 ± 5.1 years) were recruited by midwives at their primary care centres during their first pregnancy visit.…”

Anemia in pregnancy: cliniсо-pathogenetic approaches to the management of pregnancy

“…У детей в раннем неонатальном периоде отме-чаются большая потеря массы тела и более мед-ленное ее восстановление, запоздалое отпаде-ние пуповинного остатка, длительное течение физиологической желтухи, нарушение процес-са становления микробиоценоза кишечника. Гнойно-септические заболевания, обусловлен-ные относительным иммунодефицитным со-стоянием, развиваются в два раза чаще, чем у детей здоровых матерей [9,24,25].…”

“…Согласно современным данным дефицит же-леза в конце гестационного процесса развива-ется у всех беременных либо в скрытой, либо в явной форме [8,9]. Это связано с тем, что бе-ременность сопровождается дополнительной потерей железа (около 1200 мг).…”