Improving Mothers for a Better PrenAtal Care Trial Barcelona

Conditions

Fetal Growth Retardation, Intrauterine Growth Restriction

Keywords

Mindfulness, Mediterranean diet, Neurodevelopment, Epigenetics, Fetal growth restriction

Brief summary

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.

Detailed description

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.

Selma-Royo M, Crispi F, Castro-Barquero S, Casas I, Larroya M, Genero M, Paules C, Benitez L, Youssef L, Pascal R, Encabo N, Nakaki A, Martín-Asuero A, Oller-Guzmán MT, Arranz A, Vieta E, Casas R, Estruch R, Gratacos E, Collado MC, Crovetto F.

2025-08-052 citations

10.1016/j.ajcnut.2025.07.030

Validation of a pregnancy-adapted Mediterranean Diet Adherence Screener (preg-MEDAS): a validation study nested in the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial

Sara Castro‐Barquero, F. Crovetto, Ramón Estruch, Ana María Ruiz-León, Marta Larroya et al. (17 authors)

American Journal of Clinical Nutrition2024-06-016 citations

10.1016/j.ajcnut.2024.05.025

Effect of a Mediterranean Diet or Mindfulness-Based Stress Reduction During Pregnancy on Child Neurodevelopment

F. Crovetto, A. Nakaki, Ángela Arranz, Roger Borràs, Kilian Vellvé et al. (23 authors)

JAMA Network Open2023-08-2232 citations

10.1001/jamanetworkopen.2023.30255

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

F. Crovetto, F. Crispi, Rosa Casas, Andrés Martín-Asuero, Roger Borràs et al. (27 authors)

JAMA2021-12-07102 citations

10.1001/jama.2021.20178

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.

Crovetto F, Crispi F, Borras R, Paules C, Casas R, Martín-Asuero A, Arranz A, Vieta E, Estruch R, Gratacós E.

2021-05-2422 citations

10.1186/s13063-021-05309-2

VP38.14: Improving Mothers for a better PrenAtal Care Trial Barcelona (IMPACT BCN): randomised controlled trial study protocol

F. Crovetto, F. Crispi, R Borras, Rosa Casas, Amit Martin - et al. (8 authors)

Ultrasound in Obstetrics and Gynecology2020-10-01

10.1002/uog.22933

Interventions

BEHAVIORALMediterranean diet

Mediterranean diet supplemented with extra-virgin olive oil and nuts

BEHAVIORALMindfulness

Mindfulness-Based Stress Reduction program (MBSR)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Masking description

Care provider will not know the arm of randomization

Intervention model description

Randomized controlled trial with 3 arms of intervention

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Fetal Growth Restriction (FGR)	Delivery	Birth weight \<10th percentile

Secondary

Measure	Time frame	Description
Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)	Pregnancy	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)

Other

Measure	Time frame	Description
Fetal Programming	Up to 24 months of age	Neurodevelopment assessment with Bayley III test
Epigenetics	Delivery	Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention

Countries

Spain

Outcome results

None listed