Improving Mothers for a Better PrenAtal Care Trial Barcelona (IMPACTBCN)

Hospital Clinic of Barcelona

Status: Completed

Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction

Treatments: Behavioral: Mediterranean diet; Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT03166332

IMPACT BCN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,221 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,221 participants in 3 patient groups

Mediterranean diet

Active Comparator group

Description:

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

Treatment:

Behavioral: Mediterranean diet

Mindfulness

Active Comparator group

Description:

Mindfulness-Based Stress Reduction program (MBSR)

Treatment:

Behavioral: Mindfulness

No intervention

No Intervention group

Description:

No intervention strategy