Improving Mothers for a Better PrenAtal Care Trial Barcelona

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Intrauterine Growth Restriction Fetal Growth Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with 3 arms of intervention

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Care provider will not know the arm of randomization

Study Groups

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Mediterranean diet

Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.

Group Type ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type BEHAVIORAL

Mediterranean diet supplemented with extra-virgin olive oil and nuts

Mindfulness

Mindfulness-Based Stress Reduction program (MBSR)

Group Type ACTIVE_COMPARATOR

Mindfulness

Intervention Type BEHAVIORAL

Mindfulness-Based Stress Reduction program (MBSR)

No intervention

No intervention strategy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mediterranean diet

Mediterranean diet supplemented with extra-virgin olive oil and nuts

Intervention Type BEHAVIORAL

Mindfulness

Mindfulness-Based Stress Reduction program (MBSR)

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No