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Completed

NCT Number: NCT03166332

Improving Mothers for a Better PrenAtal Care Trial Barcelona

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean Diet

Behavioral

Mediterranean diet supplemented with extra-virgin olive oil and nuts

Mindfulness

Behavioral

Mindfulness-Based Stress Reduction program (MBSR)

Primary outcomes

  1. Fetal Growth Restriction (FGR)

    Time frame: Delivery

    Birth weight <10th percentile

Secondary outcomes

  1. Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)

    Time frame: Pregnancy

    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)

Other outcomes

  1. Fetal Programming

    Time frame: Up to 24 months of age

    Neurodevelopment assessment with Bayley III test

  2. Epigenetics

    Time frame: Delivery

    Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: IMPACTBCN

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 25, 2017
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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