Improving Mothers for a Better PrenAtal Care Trial Barcelona

Fetal Growth Retardation Clinical Trial

— IMPACTBCN  

Official title:

Improving Mothers for a Better PrenAtal Care Trial Barcelona

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166332
• Other study ID #: IMPACT BCN
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1221
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

Behavioral:
• Mediterranean diet
Mediterranean diet supplemented with extra-virgin olive oil and nuts
• Mindfulness
Mindfulness-Based Stress Reduction program (MBSR)

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Sant Joan de Deu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fetal Programming	Neurodevelopment assessment with Bayley III test	Up to 24 months of age
Other	Epigenetics	Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention	Delivery
Primary	Fetal Growth Restriction (FGR)	Birth weight <10th percentile	Delivery
Secondary	Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)	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)	Pregnancy