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

Abstract

Background Fetal growth restriction (FGR) affects 7–10% of all pregnancies resulting in a higher risk of perinatal morbidity and mortality, long-term disabilities, and cognitive impairment. Due to its multifactorial etiology, changes in maternal lifestyle, including suboptimal maternal diet and stress, have increasingly been associated with its prevalence. We present a protocol for the Improving Mothers for a better PrenAtal Care Trial Barcelona (IMPACT BCN), which evaluates two different maternal lifestyle strategies (improved nutrition by promoting Mediterranean diet and stress reduction program based on mindfulness techniques) on perinatal outcomes. The primary objective is to reduce the prevalence of FGR. Secondary aims are to reduce adverse perinatal outcomes and to improve neurodevelopment and cardiovascular profile in children at 2 years of age. Methods A randomized parallel, open-blind, single-center trial following a 1:1:1 ratio will select and randomize high-risk singleton pregnancies for FGR (N=1218), according to the criteria of the Royal College of Obstetricians and Gynaecologists (19.0–23.6 weeks’ gestation), into three arms: Mediterranean diet, mindfulness-based stress reduction program, and usual care without any intervention. Compliance to the interventions will be randomly tested in 30% of participants with specific biomarkers. Maternal socio-demographic, clinical data, biological samples, and lifestyle questionnaires will be collected at enrollment and at the end of the interventions (34.0–36.6 weeks’ gestation), together with a fetoplacental ultrasound and magnetic resonance. Fetoplacental biological samples and perinatal outcomes will be recorded at delivery. Postnatal follow-up is planned up to 2 years of corrected age including neurodevelopmental tests and cardiovascular assessment. Intention-to-treat and population per-protocol analysis will be performed. Discussion This is the first randomized study evaluating the impact of maternal lifestyle interventions during pregnancy on perinatal outcomes. The maternal lifestyle interventions (Mediterranean diet and mindfulness-based stress reduction program) are supported by scientific evidence, and their compliance will be evaluated with several biomarkers. Trial registration ClinicalTrials.govNCT03166332. Registered on April 19, 2017

Impact of the COVID-19 Pandemic on Maternal Well-Being during Pregnancy

“…The pandemic cohort was compared to a previous cohort of pregnant women recruited between February 2017 and October 2019 before the COVID-19 pandemic [19] (Table A1).…”

Identification, Characterization, and Antioxidant Potential of Bifidobacterium longum subsp. longum Strains Isolated From Feces of Healthy Infants

“…Therefore, it is vital to evaluate the antibiotic resistance properties of bacteria. Furthermore, the development of the intestinal tract is significant in infants; immature intestines and slow intestinal immune development were associated with the high risk of postpartum growth restriction, lactose intolerance, allergy, necrotizing enterocolitis, and other intestinal related diseases ( Zhuang et al, 2019 ; Osorio, 2020 ; Crovetto et al, 2021 ). Studies confirmed that probiotics were beneficial to intestinal development, intestinal epithelial renewal, and intestinal mucosa balance ( Blumberg and Gensollen, 2017 ; Zhuang et al, 2019 ).…”

Hypertensive Disorders of Pregnancy and Fetal Growth Restriction: Clinical Characteristics and Placental Lesions and Possible Preventive Nutritional Targets

“…Growing evidence has shown the positive effects of the Mediterranean diet (MD) on health outcomes (i.e., lower incidence of cardiovascular and metabolic diseases, lower incidence of neurodegenerative diseases, lower incidence of multiple cancer sites, and lower mortality) [23][24][25][26]45]. The traditional Mediterranean diet is a plant-oriented dietary pattern characterized by a high intake of vegetables, fruit, whole grains, legumes, and nuts; a moderate intake of dairy products (mostly cheese and yoghurt); a moderate intake of fish and poultry; a low intake of red meat; a high intake of extra-virgin olive oils, used as the main source of fat; and a moderate intake of wine, consumed with meals [46].…”

“…Moreover, recent research findings pointed out suboptimal maternal diet [23][24][25] and maternal stress as potentially important contributors [26]. We hypothesize that the analysis of the placental histology might contribute to differentiate the phenotypes of HDP and of FGR as well as their possible overlapping in the real-life clinical scenario.…”