Improving Mothers for a Better PrenAtal Care Trial Barcelona

Hospital Clinic of Barcelona1,221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,221

Conditions

Intrauterine Growth Restriction Fetal Growth Retardation

Interventions

Mediterranean dietBEHAVIORAL

Mediterranean diet supplemented with extra-virgin olive oil and nuts

MindfulnessBEHAVIORAL

Mindfulness-Based Stress Reduction program (MBSR)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Outcomes

Primary Outcomes

Fetal Growth Restriction (FGR)

Birth weight \<10th percentile

Time frame: Delivery

Secondary Outcomes

Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)

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)

Time frame: Pregnancy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.