Effect of the adaptation of the iron supplementation dose in pregnancy on maternal and filial health. Protocol of the ECLIPSES randomized clinical trial.
To determine the highest level of effectiveness on the improvement of the maternal and filial health of iron supplementation adapted to hemoglobin levels in early pregnancy compared to the currently recommended dose.
Randomized Clinical Trial (RCT) triple-blinded. Multicenter study in 10 Sexual and Reproductive Health Care Central Units from Tarragona. 800 will be participating non-anemic pregnant women in early pregnancy and their children. The study is structured in 2 RCTs, depending on the Hb levels at week 10 of gestation.
RCT 1: Hb from 110 to 130 g/L and random prescription of 40 or 80 mg/d of iron at week 12.
RCT 2: Hb from 130 to 150 g/L and random prescription of 40 or 20 mg/d of iron at week 12.
The variables measured in the mother were: Hb, serum ferritin, protein C reactive, cortisol, alterations in the HFE gene: C282Y, H63D, food frequency, lifestyle, emotional state and adherence to iron supplementation.
In children: ultrasound fetal biometry, anthropometric measurements, temperament and neurobehavioral development.
Statistical analyses were performed in bivariate and multivariate analyses adjusted for confounding variables, using the SPSS program for Windows.