Improving Mothers for a Better PrenAtal Care Trial Barcelona

Not Applicable

Completed

• Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction
• Interventions: Behavioral: Mediterranean diet; Behavioral: Mindfulness

• Registration Number: NCT03166332
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-25
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-16
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1221

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	Mediterranean diet	Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.
Mindfulness	Mindfulness	Mindfulness-Based Stress Reduction program (MBSR)

Primary Outcome Measures

Name	Time	Method
Fetal Growth Restriction (FGR)	Delivery	Birth weight \<10th percentile

Secondary Outcome Measures

Name	Time	Method
Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)	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)

Trial Locations

Locations (2)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain