- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403632
Mediterranean Diet on Pregnancy and Foetus Development
Influence of Mediterranean Dietary Habits on Pregnancy and Foetus Development: the Role of Epigenetics and Inflammation
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Licia Iacoviello, MD
- Phone Number: +39 3485108779
- Email: licia.iacoviello@moli-sani.org
Study Contact Backup
- Name: Simona Esposito, msc
- Phone Number: +39 3389683142
- Email: simona.esposito@moli-sani.org
Study Locations
-
-
SA
-
Agropoli, SA, Italy, 84043
- Recruiting
- Istituto Clinico Mediterranea
-
Contact:
- Paola De Domenico, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
obstetric and perinatal complications
Time Frame: 9 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
new-born growth and development
Time Frame: 9 months
|
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.
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
infant physical development
Time Frame: 24 months
|
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.
|
24 months
|
infant neurocognitive development
Time Frame: 24 months
|
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. |
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Licia Iacoviello, MD, IRCCS Neuromed
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEP_012022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Infant Development
-
Société des Produits Nestlé (SPN)RecruitingInfant Development | Growth and Development | Infant Health | Infant Formula | Infant Nutritional Physiological PhenomenaSaudi Arabia
-
University of ArizonaMead Johnson NutritionRecruiting
-
Hugo W. Moser Research Institute at Kennedy Krieger...Johns Hopkins UniversityEnrolling by invitationChild Development | Developmental Delay | Infant Development | Language DevelopmentUnited States
-
Children's Hospital Los AngelesBrigham and Women's Hospital, Boston USA; Wuqu' Kawoq - Maya Health Alliance...RecruitingInfant DevelopmentGuatemala
-
Northwestern UniversityStanford UniversityActive, not recruiting
-
University Hospital, MontpellierCompletedInfant DevelopmentFrance
-
Bellamy's Organic Pty LtdActive, not recruitingInfant DevelopmentChina
-
Columbia UniversityCompleted
-
Centre Hospitalier Intercommunal CreteilCompleted
-
University of WashingtonNational Institute of Neurological Disorders and Stroke (NINDS)TerminatedInfant DevelopmentUnited States