INTRODUCTION
Starting with the Barker’s hypothesis in the early 90’, maternal nutrition during pregnancy has been recognized as a crucial determinant of placental function and intrauterine growth, with long-lasting and intergenerational effects on future disease risk profile of the offspring (1-4). This long-term “programming” of future health status has been related to maternal nutritional exposures mainly through epigenetic modifications, that could realize both before conception -by affecting the process of gametogenesis- and during pregnancy (5,6).
Currently, the adherence to nutritional guidelines is dangerously low, with alarming rates of obesity worldwide and micronutrient deficiencies that have been documented even in industrialized countries (7-10). Therefore, a universal nutritional counselling and screening represent a pivotal issue in early pregnancy, requiring proper evaluations in order to improve both individual and population health. In this setting, the development of a simple and reproducible nutritional checklist is of utmost importance.
In this context, a pilot study on 112 healthy women with singleton pregnancies and non-malformed outcome demonstrated that a first trimester nutritional score measuring the adherence to a healthy diet and lifestyle in early pregnancy was significantly associated with first trimester biochemical and ultrasound markers of placental function (11). In particular, higher maternal nutritional scores were associated with increased serum pregnancy-associated plasma protein-A (PAPP-A) concentrations, lower uterine artery mean pulsatility index, and decreased placental volume at the first trimester screening ultrasound, whereas no associations were detected with free β-human chorionic gonadotropin (free β-HCG). The analysis on birth outcomes additionally showed a significant positive association between first trimester maternal nutritional score and gestational age at birth. These results provided the evidence of a strong association between maternal nutritional habits and pregnancy outcomes, possibly mediated by early impacts on placental function and development. Furthermore, this study possibly provided a simple clinical tool for an early nutritional screening deeply impacting on pregnancy outcome and clinical practice.
The Simple Study is a longitudinal prospective multicenter study designed to identify possible associations between first trimester maternal nutritional score, early markers of placental function, and pregnancy outcome on a large population of singleton pregnancies in Italy. In particular, the aims of the study are:
- to assess first trimester nutritional score and nutritional adequacy in a large population of singleton pregnancies;
- to investigate associations between first trimester maternal nutritional score and early markers of placental function and fetal growth;
- to evaluate associations between first trimester nutritional score and maternal, fetal and neonatal outcomes, including: birthweight, gestational age at birth, blood loss at delivery, gestational weight gain, adverse maternal (hypertensive disorders, gestational diabetes and cesarean section) and feto-neonatal outcomes (intrauterine growth restriction, preterm delivery).