Improving Mothers for a Better PrenAtal Care Trial Barcelona

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Mothers for a Better PrenAtal Care Trial Barcelona

Conditions
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Intrauterine Growth Restriction, Fetal Growth Retardation

Intervention / Treatment
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* Behavioral: Mediterranean diet
* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 3 arms of intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mediterranean diet<br>Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts. | Behavioral: Mediterranean diet<br>* Mediterranean diet supplemented with extra-virgin olive oil and nuts<br>|
| Active Comparator: Mindfulness<br>Mindfulness-Based Stress Reduction program (MBSR) | Behavioral: Mindfulness<br>* Mindfulness-Based Stress Reduction program (MBSR)<br>|
| No Intervention: No intervention<br>No intervention strategy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Growth Restriction (FGR) | Birth weight <10th percentile | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Mediterranean diet, Neurodevelopment, Epigenetics, Fetal growth restriction