NCT03166332

Improving Mothers for a Better PrenAtal Care Trial Barcelona

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,221 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrauterine Growth Restriction
• Fetal Growth Retardation

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean diet	Mediterranean diet supplemented with extra-virgin olive oil and nuts
BEHAVIORAL	Mindfulness	Mindfulness-Based Stress Reduction program (MBSR)

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2017-05-25
• Last updated: 2022-04-19

Locations

2 sites across 1 country: Spain