Improving Mothers for a Better PrenAtal Care Trial Barcelona (IMPACTBCN)

High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.

Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet. Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development. Secondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring.

Development of one of the following conditions: preeclampsia, preterm delivery, severe FGR (birth weight <3rd percentile), perinatal mortality, metabolic acidosis, mejor neonatal morbidity (presence of intraventricular hemorrhage grade III/IV, necrotizing enterocolitis, periventricular leucomalacia, sepsis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy)

Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention

Inclusion Criteria: Maternal age at recruitment ≥18 years Speak Spanish fluently Viable singleton non-malformed fetus High-risk pregnancy to develop FGR. 19-23 weeks of gestation Exclusion Criteria: Fetal anomalies including chromosomal abnormalities or structural malformations detected by ultrasound. Mental retardation or other mental or psychiatric disorders that impose doubts regarding the true patient´s willingness to participate in the study. No possibility to come to additional visits.

Participants will be recruited in our unit and data will be available only for researchers involved in the study.

Crovetto F, Crispi F, Casas R, Martin-Asuero A, Borras R, Vieta E, Estruch R, Gratacos E; IMPACT BCN Trial Investigators. Effects of Mediterranean Diet or Mindfulness-Based Stress Reduction on Prevention of Small-for-Gestational Age Birth Weights in Newborns Born to At-Risk Pregnant Individuals: The IMPACT BCN Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2150-2160. doi: 10.1001/jama.2021.20178.

Crovetto F, Crispi F, Borras R, Paules C, Casas R, Martin-Asuero A, Arranz A, Vieta E, Estruch R, Gratacos E. Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial. Trials. 2021 May 24;22(1):362. doi: 10.1186/s13063-021-05309-2.