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

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ClinicalTrials.gov Identifier: NCT03166332
Recruitment Status : Active, not recruiting
First Posted : May 25, 2017
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eduard Gratacós Solsona, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE May 25, 2017
Last Update Posted Date February 15, 2021
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2017)
Fetal Growth Restriction (FGR) [ Time Frame: Delivery ]
Birth weight <10th percentile
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
Fetal Growth Restriction (FGR) [ Time Frame: Pregnancy ]
Birth weight <10th percentile
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Improving Mothers for a Better PrenAtal Care Trial Barcelona
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Intrauterine Growth Restriction
  • Fetal Growth Retardation
Intervention  ICMJE
  • Behavioral: Mediterranean diet
    Mediterranean diet supplemented with extra-virgin olive oil and nuts
  • Behavioral: Mindfulness
    Mindfulness-Based Stress Reduction program (MBSR)
Study Arms  ICMJE
  • 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, Borras R, Paules C, Casas R, Martín-Asuero A, Arranz A, Vieta E, Estruch R, Gratacós 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 11, 2021)
1221
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
1218
Estimated Study Completion Date  ICMJE February 1, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03166332
Other Study ID Numbers  ICMJE 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  ICMJE
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.
Responsible Party Eduard Gratacós Solsona, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP