Clinical trial NCT03166332: Improving Mothers for a Better PrenAtal Care Trial Barcelona
Official title: Improving Mothers for a Better PrenAtal Care Trial Barcelona
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Growth Restriction
Fetal Growth Retardation
Keywords: Mindfulness
Mediterranean diet
Neurodevelopment
Epigenetics
Fetal growth restriction
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 1221
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 3 arms of intervention
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal Growth Restriction (FGR)
timeFrame: Delivery
Secondary outcomes:
measure: Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)
timeFrame: Pregnancy
Other outcomes:
measure: Fetal Programming
timeFrame: Up to 24 months of age
measure: Epigenetics
timeFrame: Delivery
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
Study officials:
References:
citation: Crovetto F, Crispi F, Casas R, Martin-Asuero A, Borras R, Vieta E, Estruch R, Gratacos E; IMPACT BCN Trial Investigators. Effects of Mediterranean Diet or Mindfulness-Based Stress Reduction on Prevention of Small-for-Gestational Age Birth Weights in Newborns Born to At-Risk Pregnant Individuals: The IMPACT BCN Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2150-2160. doi: 10.1001/jama.2021.20178.
citation: Crovetto F, Crispi F, Borras R, Paules C, Casas R, Martin-Asuero A, Arranz A, Vieta E, Estruch R, Gratacos E. Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial. Trials. 2021 May 24;22(1):362. doi: 10.1186/s13063-021-05309-2.