Mediterranean Diet on Pregnancy and Foetus Development

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorNeuromed IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

pregnancy with foetuses with known chromosomal or congenital malformation

history of inflammatory disease

use of immunosuppressant drugs

pre-existing diabetes or hypertension

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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, %).

Time frame
9 months

Secondary outcomes

1

new-born growth and development

Seven measurements will be taken at each visit to measure foetal growth by using fetal ultrasound examination: Biparietal and Occipito-Frontal Diameters (in cm); Head Circumference (in cm); Transverse abdominal diameter (in cm); Anterio-posterior abdominal diameter (in cm); Abdominal Circumference (in cm) and Femur Length (in cm). Intrauterine growth restriction will be defined as Delphi criteria. At birth to evaluate growth and development by trained nurses using standardized protocols: Apgar score, birthweight (in kg), length (in cm), upper arm length (in cm), upper thigh length (in cm), head circumference (in cm), abdominal circumference (in cm). Birthweight (in kg) and gestational age (in weeks) at delivery will be used to categorize each neonate as small-for-gestational age, appropriate-for-gestational age, or large-for-gestational age, using a sex-specific reference. Gestational age (in weeks) will be confirmed through a first-trimester ultrasound examination.

Time frame
9 months

Other outcomes

1

infant physical development

Offspring development will be assessed at 6, 12, 18, 24 months of age for each baby. Mothers will report i) breastfeeding and weaning of the baby by questionnaire; ii) anthropometric assessments at each paediatric periodical check, in particular height (cm) and weight (kg) will be measured; iii) any medical issue of the baby by questionnaire.

Time frame
24 months
2

infant neurocognitive development

Mothers will report i) measures of cognitive development like age (days) at first word, age at object manipulation (days), level of social interactions of the baby and ability to imitate/respond to the language of adults ; ii) sensory-related skills like ability to discriminate familial sounds and recognize familial faces (low/medium/high). To evaluate neuro-cognitive development we will use the Bayley Scales of Infant Development (BSID-II) score, the most widely used test of infant development.

Time frame
24 months

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