Associations between maternal first trimester SIMPLE nutritional score,
early placental markers and pregnancy outcome: a prospective multicenter
Italian study (SIMPLE study) protocol
Abstract
Currently, the adherence to nutritional guidelines is critically low,
with alarming rates of obesity worldwide and micronutrient deficiencies
documented even in industrialized countries. As a consequence,
nutritional screening and counselling represent a critical subject in
early pregnancy, aiming to improve pregnancy outcome and population
health. In this setting, the development of a simple and reproducible
nutritional checklist is of utmost importance. The Simple Study is a
longitudinal prospective multicenter study aiming to identify the
associations between nutritional habits in the first trimester, early
markers of placental function, and pregnancy outcome on a large
population of singleton pregnancies in Italy. Ongoing healthy singleton
pregnancies will be enrolled at the ultrasound scan of the first
trimester combined screening test (11+0-13+6 gestational weeks). A
nutritional score measuring the adherence to a healthy diet and
nutritional deficiencies will be collected at recruitment. Fetal
(crown-rump length, nuchal translucency, biparietal diameter, femur
length) and utero-placental (placental volume, uterine arteries Doppler
velocimetry) ultrasound data and biochemical placental markers
(Pregnancy Associated Plasma Protein A (PAPP-A), free ß-Human Chorionic
Gonadotropin (HCG)) will be collected. Second and third trimester
ultrasound records and birth outcomes will be recorded from medical
registers. The present study will set the stage for introducing a
reproducible, time-saving and low-cost nutritional screening in
pregnancy. The nutritional score will allow the implementation of
specific corrective measures with potential large impact on placentation
and pregnancy outcome.