Improving Mothers for a Better PrenAtal Care Trial Barcelona (IMPACTBCN)

• ClinicalTrials.gov Identifier: NCT03166332
• Recruitment Status: Completed
• First Posted: May 25, 2017
• Last Update Posted: April 19, 2022
• Sponsor: Hospital Clinic of Barcelona
• Information provided by (Responsible Party): Eduard Gratacós Solsona, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: April 19, 2017
• First Posted Date: May 25, 2017
• Last Update Posted Date: April 19, 2022
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2017)

Fetal Growth Restriction (FGR) [ Time Frame: Delivery ]

Birth weight <10th percentile

Original Primary Outcome Measures (submitted: May 22, 2017)

Fetal Growth Restriction (FGR) [ Time Frame: Pregnancy ]

Birth weight <10th percentile

Current Secondary Outcome Measures (submitted: May 22, 2017)

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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 27, 2017)

• Fetal Programming [ Time Frame: Up to 24 months of age ]
  Neurodevelopment assessment with Bayley III test
• 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

Original Other Pre-specified Outcome Measures (submitted: May 22, 2017)

• Fetal Programming [ Time Frame: Up to 24 months of age ]
  Neurodevelopment and cardiovascular
• Epigenetics [ Time Frame: Pregnancy ]
  Epigenetic changes

Descriptive Information

• Brief Title: Improving Mothers for a Better PrenAtal Care Trial Barcelona
• Official Title: Improving Mothers for a Better PrenAtal Care Trial 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial with 3 arms of intervention

Masking: Single (Care Provider)
Masking Description:

Care provider will not know the arm of randomization

Primary Purpose: Prevention

Condition

• Intrauterine Growth Restriction
• Fetal Growth Retardation

Intervention

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

Study Arms

• Active Comparator: Mediterranean diet
  Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.
  Intervention: Behavioral: Mediterranean diet
• Active Comparator: Mindfulness
  Mindfulness-Based Stress Reduction program (MBSR)
  Intervention: Behavioral: Mindfulness
• No Intervention: No intervention
  No intervention strategy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 11, 2021): 1221
• Original Estimated Enrollment (submitted: May 22, 2017): 1218
• Actual Study Completion Date: December 31, 2021
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03166332
• Other Study ID Numbers: IMPACT BCN
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Participants will be recruited in our unit and data will be available only for researchers involved in the study.

• Current Responsible Party: Eduard Gratacós Solsona, Hospital Clinic of Barcelona
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Clinic of Barcelona
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital Clinic of Barcelona
• Verification Date: April 2022