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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166332
Recruitment Status : Completed
First Posted : May 25, 2017
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Eduard Gratacós Solsona, Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Fetal Growth Retardation Behavioral: Mediterranean diet Behavioral: Mindfulness Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1221 participants
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
Official Title: Improving Mothers for a Better PrenAtal Care Trial Barcelona
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mediterranean diet
Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.
 Behavioral: Mediterranean diet
Mediterranean diet supplemented with extra-virgin olive oil and nuts
Active Comparator: Mindfulness
Mindfulness-Based Stress Reduction program (MBSR)
 Behavioral: Mindfulness
Mindfulness-Based Stress Reduction program (MBSR)
No Intervention: No intervention
No intervention strategy


Outcome Measures
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Primary Outcome Measures :
  1. Fetal Growth Restriction (FGR) [ Time Frame: Delivery ]
    Birth weight <10th percentile


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. Fetal Programming [ Time Frame: Up to 24 months of age ]
    Neurodevelopment assessment with Bayley III test

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166332


Locations
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Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital Sant Joan de Deu
Barcelona, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eduard Gratacós Solsona, Director of ICGON and BCNatal, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03166332    
Other Study ID Numbers: IMPACT BCN
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduard Gratacós Solsona, Hospital Clinic of Barcelona:
Mindfulness
Mediterranean diet
Neurodevelopment
Epigenetics
Fetal growth restriction
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes