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

April 16, 2022 updated by: Eduard Gratacós Solsona, Hospital Clinic of Barcelona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic Barcelona
      • Barcelona, Spain
        • Hospital Sant Joan De Deu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Growth Restriction (FGR)
Time Frame: Delivery
Birth weight <10th percentile
Delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pregnancy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Programming
Time Frame: Up to 24 months of age
Neurodevelopment assessment with Bayley III test
Up to 24 months of age
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
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT BCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants will be recruited in our unit and data will be available only for researchers involved in the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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