Mediterranean Diet on Pregnancy and Foetus Development

NCT05403632 | Recruiting

• 1 other identifier: DEP_012022
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Mediterranean-style diet has been associated with longevity, long-life wellbeing, lower risk of cardiovascular disease, cancer, obesity, and metabolic syndrome. Research is pointing to the benefits that MeD could have in pregnant. Pregnancy is a very complex period and recently, the attention has been focused on the possibility that healthy dietary patterns positively influence pregnancy and the development of organs in the offspring. The mechanisms through which MeD influences pregnancy and fetal growth may partly depend on its antinflammatory properties and possibly on changes in epigenetic mechanisms. Systemic inflammation might contribute to the association between maternal obesity and less favorable neurodevelopmental outcomes. The investigators aim to define how maternal adhesion to MeD may affect pregnancy and new-born development, hence representing a notable burden from a public health and social perspective. Main objective of this project is to build up a birth cohort suitable to investigate the role of maternal dietary habits on maternal and new-born health, with special focus on MeD and its possible mechanism of action through epigenetic and inflammation changes. To establish a mother/new-born cohort, collect detailed information on maternal dietary habits and set-up a biobank of biological samples to evaluate the association between dietary habits and pregnancy outcomes. The investigators will recruit 2000 pairs (mother, new-born) in different obstetrics departments. To investigate the association between maternal dietary habits, foetal growth and offspring development and possible mediation by the inflammation profile of the mother. To understand whether maternal dietary habits are associated with epigenetic changes in the offspring and if this process is driven by the inflammation profile of the mother. Venous blood samples will be obtained at the baseline and at each gestational period for ultrasound at 11-13 gestational weeks, 20-22 weeks and 30-32 weeks. Women will be followed-up with standard clinical and 2D ultrasound examinations at gestational weeks 11-13, 20-22 and 30-32 to evaluate the fetal growth. Offspring development will be assessed at 6, 12, 18, 24 months of age. After delivery, the investigators will collect umbilical cord blood and saliva samples from new-born using standard procedures. To understand if new-born epigenetics is associated with infant physical and neurocognitive development in the following 2 years.

Conditions

Pregnancy Outcomes; Fetal Development; Infant Development

Outcome Measures

Primary Outcomes (1)

• obstetric and perinatal complications

  Pregnancy and delivery complications will be obtained from the mother's medical records. The presence of the following obstetric and perinatal complications will be recorded: excessive weight gain (kg), gestational diabetes (n,%), hypertension (n, %) , eclampsia (n, %), spontaneous early and late abortion (n, %), spontaneous and iatrogenic preterm delivery or preterm premature rupture of membranes (n, %).

  9 months

Secondary Outcomes (1)

• new-born growth and development

  9 months

Other Outcomes (2)

• infant physical development

  24 months

• infant neurocognitive development

  24 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pregnant women attending the Units of Obstetrics and Gynecology at Neuromed Clinical Research Network (Casa di Cura Villa del Sole, Salerno, Istituto Clinico mediterraneo, Agropoli (SA), Casa di Cura Villa dei Platani, Avellino e Clinica Mediterranea, Napoli). Inclusion into the study takes place during the first prenatal visit and within the first trimester of pregnancy, and involves women who express the willing to deliver at the aforementioned operating units. All recruited women will sign an informed consent to participate in the study and an informed consent for genetic studies. Each woman, as well as the father of the child, will sign the written consent to processing of personal and genetic data of their new-born.

You may qualify if:

• pregnant women attending the Units of Obstetrics and Gynecology at Neuromed Clinical Research Network
• women within the first trimester of pregnancy
• women who express the willing to deliver at the aforementioned operating units

You may not qualify if:

• pregnancy with foetuses with known chromosomal or congenital malformation
• history of inflammatory disease
• use of immunosuppressant drugs
• pre-existing diabetes or hypertension
• conception by heterologous artificial insemination
• malabsorptive bariatric surgery
• eating disorders

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Istituto Clinico Mediterranea

Agropoli, SA, 84043, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples, umbilical cord blood, saliva samples

Study Officials

• Licia Iacoviello, MD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Licia Iacoviello, MD

CONTACT

+39 3485108779; licia.iacoviello@moli-sani.org

Simona Esposito, msc

CONTACT

+39 3389683142; simona.esposito@moli-sani.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: June 3, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

IT (1)