Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288126
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-06
Brief Title:
Maternal and Fetal Metabolic Changes
Sponsor:
Azienda Ospedaliero Universitaria Pisana
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Evaluation of Clinical and Ecographic Risk Markers in Pregnancies at High and Low Risk for the Development of Glycemic and Metabolic Complications in Pregnancy
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoMM-FET
Brief Summary:
The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies obtaining an early detection of metabolic changes offering new insights into future prevention and treatment strategies for both mother and offspring
Primary objectives
measurement of maternal blood adipokine levels during the first trimester of pregnancy in two groups of women high and low risk in order to identify early markers which in conjunction with the medical history can identify women at increased risk of developing GDM
ultrasound measurement of adipose tissue deposits at ectopic sites comparing low- and high-risk women and assessing the effect of pregnancy on these deposits
Identification by targeted ultrasound assessment of fetuses at increased risk of macrosomia
Secondary objectives
Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women
Evaluation of neonatal complications in children born to low- and high-risk mothers need for resuscitation hypoglycaemia hypocalcaemia admission to neonatal intensive care unit
The participants will be recruited during first trimester ultrasound after signing the informed consent
Primary objectives
measurement of maternal blood adipokine levels during the first trimester of pregnancy in two groups of women high and low risk in order to identify early markers which in conjunction with the medical history can identify women at increased risk of developing GDM
ultrasound measurement of adipose tissue deposits at ectopic sites comparing low- and high-risk women and assessing the effect of pregnancy on these deposits
Identification by targeted ultrasound assessment of fetuses at increased risk of macrosomia
Secondary objectives
Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women
Evaluation of neonatal complications in children born to low- and high-risk mothers need for resuscitation hypoglycaemia hypocalcaemia admission to neonatal intensive care unit
The participants will be recruited during first trimester ultrasound after signing the informed consent
Detailed Description:
Pregnancy has been defined a stress test for life During pregnancy even if uncomplicated women experience metabolic and cardiovascular changes that predispose to vascular endothelial dysfunction Women who are already predisposed to this phenotype develop gestational hypertension or gestational diabetes GDM which can re-emerge later in life This has been demonstrated by several studies in which the presence of pregnancy diseases GDM maternal preeclampsia and fetal growth disorder correlate with the development of chronic disorders such as chronic hypertension diabetes mellitus and metabolic syndrome suggesting a common pathogenic pathway From this point of view pregnancy constitutes a unique period to evaluate metabolic and cardiovascular markers to better understand the pathogenesis of these disorders and possibly obtain preventive strategies The identification of early biomarkers of metabolic dysfunction would be particularly useful in overweight and obese pregnant women There is a growing prevalence of obesity worldwide in developed Countries 40-50 of the pregnant population is overweight and obese which is according to a recent report from the United Kingdom the main contributing cause of death during gestation
In addition obesity and maternal hyperglycaemia during pregnancy may induce intrauterine overnutrition and fetal hyperinsulinemia resulting in excessive fetal growth Fetal macrosomia is associated with an increased risk of perinatal morbidity and mortality Large babies have increased risk of intrapartum complications such as prolonged labour and shoulder dystocia Moreover the environmental and metabolic characteristics of intrauterine life deeply influence the individual in the long-term as a child and through adulthood with possible adverse metabolic consequences including predisposition to insulin resistance and obesity
The evaluation of fetal tissue distribution and the recently introduced study of the fetal liver volume constitute very interesting markers of fetal adiposity and could be used as early indicators of insulin resistance in newborns
The participants will be recruited during first trimester ultrasound after signing the informed consent At 11-13 weeks
Ultrasound evaluation of fetal biometry and amniotic fluid will be performed Periodic maternal anthropometric evaluation weight gain and body mass index BMI blood pressure Women will be divided in lean overweight and obese
Blood sample for inflammatory cytokines will be taken
Maternal body composition evaluation through bioimpedance andor highly reliable ultrasound-based analysis of ectopic fat This approach is ideal to provide biomarkers of insulin resistance In brief women will be evaluated by a standardized set of US clips for the assessment of liver fat cardiac fat abdominal subcutaneous and visceral fat
At 16-18 weeks standard screening for gestational diabetes for high risk women as for clinical practice
At 24-28 weeks
Standard screening for gestational diabetes to all women
Fetal ultrasound to study fetal liver volume andor subcutaneous fat tissue quantification These constitute innovative techniques to obtain an early identification of macrosomic fetuses
At delivery
Information on mode of delivery and any complications
Within 48 hours of birth anthropometric assessment of the infant according to clinical practice weight abdominal and head circumference
In addition obesity and maternal hyperglycaemia during pregnancy may induce intrauterine overnutrition and fetal hyperinsulinemia resulting in excessive fetal growth Fetal macrosomia is associated with an increased risk of perinatal morbidity and mortality Large babies have increased risk of intrapartum complications such as prolonged labour and shoulder dystocia Moreover the environmental and metabolic characteristics of intrauterine life deeply influence the individual in the long-term as a child and through adulthood with possible adverse metabolic consequences including predisposition to insulin resistance and obesity
The evaluation of fetal tissue distribution and the recently introduced study of the fetal liver volume constitute very interesting markers of fetal adiposity and could be used as early indicators of insulin resistance in newborns
The participants will be recruited during first trimester ultrasound after signing the informed consent At 11-13 weeks
Ultrasound evaluation of fetal biometry and amniotic fluid will be performed Periodic maternal anthropometric evaluation weight gain and body mass index BMI blood pressure Women will be divided in lean overweight and obese
Blood sample for inflammatory cytokines will be taken
Maternal body composition evaluation through bioimpedance andor highly reliable ultrasound-based analysis of ectopic fat This approach is ideal to provide biomarkers of insulin resistance In brief women will be evaluated by a standardized set of US clips for the assessment of liver fat cardiac fat abdominal subcutaneous and visceral fat
At 16-18 weeks standard screening for gestational diabetes for high risk women as for clinical practice
At 24-28 weeks
Standard screening for gestational diabetes to all women
Fetal ultrasound to study fetal liver volume andor subcutaneous fat tissue quantification These constitute innovative techniques to obtain an early identification of macrosomic fetuses
At delivery
Information on mode of delivery and any complications
Within 48 hours of birth anthropometric assessment of the infant according to clinical practice weight abdominal and head circumference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None