Improving Mothers for a Better PrenAtal Care Trial Barcelona
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intrauterine Growth Restriction
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 1221
- Locations
- 2
- Primary Endpoint
- Fetal Growth Restriction (FGR)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eduard Gratacós Solsona
Director of ICGON and BCNatal
Hospital Clinic of Barcelona
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.
Outcomes
Primary Outcomes
Fetal Growth Restriction (FGR)
Time Frame: Delivery
Birth weight \<10th percentile
Secondary Outcomes
- Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)(Pregnancy)