Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421493
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-07
Brief Title:
Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
Status:
RECRUITING
Status Verified Date:
2024-05
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:
MATER
Brief Summary:
Preeclampsia PE is a significant cause of maternal and fetal morbidity and mortality characterized by high blood pressure and proteinuria during pregnancy It has two main phenotypes one linked to placental damage and the other to metabolic factors like obesity Early identification of high-risk groups is crucial though theres ongoing disagreement over its classification Research suggests a potential connection between maternal gut bacteria and PE offering avenues for improved prevention strategies This study aims to investigate the differences in maternal gut microbiota between these two PE phenotypes
Detailed Description:
Preeclampsia PE is one of the leading causes of maternal and fetal morbidity and mortality It is defined as the presence of systolic blood pressure SBP 140 and diastolic blood pressure DBP 90 on two consecutive measurements six hours apart associated with proteinuria 300 mg24 h or 2 detected by urine dipstick or the presence of organ damage or intrauterine growth restriction Preeclampsia complicates 3-8 of pregnancies and is responsible for more than 76000 maternal deaths annually
Scientific evidence suggests the existence of two distinct phenotypes of the disease preeclampsia due to placental damage and preeclampsia on a metabolic basis The former phenotype recognizes altered invasion of the maternal endometrium by the trophoblast as its pathogenesis where defective trophoblast invasion leads to the development of preeclampsia often associated with early presentation in pregnancy intrauterine growth restriction IUGR and the need for delivery at low gestational ages The latter phenotype recognizes a metabolic basis which represents about 4 of hypertensive disorders of pregnancy HDP and is dependent on maternal predisposition in patients with visceral obesity and metabolic syndrome
Evidence suggests that maternal risk factors for metabolic dysfunction may lead to late placental dysfunction in pregnancy Metabolic-based preeclampsia manifests in patients with pre-existing low-grade inflammation related to truncal obesity and metabolic syndrome compounded by pregnancy-related inflammation and insulin resistance
Today starting as early as the first trimester of pregnancy maternal cardiovascular and hemodynamic function can be assessed using a non-invasive and safe method for both the mother and fetus through the USCOM Ultra Sonic Cardiac Output Monitor system This system provides real-time data on numerous central and peripheral hemodynamic parameters
There is still disagreement among scientific societies regarding the classification of preeclampsia and its possible different clinical phenotypes making personalized clinical approaches to this condition challenging However early identification of high-risk groups is becoming increasingly important for diagnostic follow-up and therapeutic strategies based on pathogenesis
Recently a screening method at 11-13 weeks of gestation has been developed to predict 75 of pregnancies that will develop preterm preeclampsia 37 weeks of gestation based on a risk calculation algorithm combining weight and height measurements mean arterial pressure measured with automated devices blood sampling for PLGF measurement and Doppler ultrasound measurement of the mean pulsatility index PI of the uterine arteries
However this screening method can only predict a portion of patients who will develop preeclampsia before 37 weeks and who may benefit from aspirin intake if administered at doses 100mg and before 16 weeks Predicting and effectively preventing preeclampsia that occurs after 37 weeks remains the subject of debate and scientific research
Among emerging etiopathogenetic hypotheses numerous scientific publications suggest that alterations in maternal immunity and immune tolerance are the basis of hypertensive disorders in pregnancy Recent discoveries suggest that changes in maternal intestinal microbiota may underlie these immune alterations Alterations in gut microbiota diversity and composition known as dysbiosis can influence systemic immune responses and metabolic disturbances such as gestational diabetes and preeclampsia posing risks of metabolic alterations in the neonate
Based on these premises this study aims to define the characteristics of maternal intestinal microbiota in the two different clinical phenotypes of preeclampsia placental preeclampsia associated with growth restriction and metabolic-based preeclampsia associated with a fetus of appropriate weight for gestational age
Scientific evidence suggests the existence of two distinct phenotypes of the disease preeclampsia due to placental damage and preeclampsia on a metabolic basis The former phenotype recognizes altered invasion of the maternal endometrium by the trophoblast as its pathogenesis where defective trophoblast invasion leads to the development of preeclampsia often associated with early presentation in pregnancy intrauterine growth restriction IUGR and the need for delivery at low gestational ages The latter phenotype recognizes a metabolic basis which represents about 4 of hypertensive disorders of pregnancy HDP and is dependent on maternal predisposition in patients with visceral obesity and metabolic syndrome
Evidence suggests that maternal risk factors for metabolic dysfunction may lead to late placental dysfunction in pregnancy Metabolic-based preeclampsia manifests in patients with pre-existing low-grade inflammation related to truncal obesity and metabolic syndrome compounded by pregnancy-related inflammation and insulin resistance
Today starting as early as the first trimester of pregnancy maternal cardiovascular and hemodynamic function can be assessed using a non-invasive and safe method for both the mother and fetus through the USCOM Ultra Sonic Cardiac Output Monitor system This system provides real-time data on numerous central and peripheral hemodynamic parameters
There is still disagreement among scientific societies regarding the classification of preeclampsia and its possible different clinical phenotypes making personalized clinical approaches to this condition challenging However early identification of high-risk groups is becoming increasingly important for diagnostic follow-up and therapeutic strategies based on pathogenesis
Recently a screening method at 11-13 weeks of gestation has been developed to predict 75 of pregnancies that will develop preterm preeclampsia 37 weeks of gestation based on a risk calculation algorithm combining weight and height measurements mean arterial pressure measured with automated devices blood sampling for PLGF measurement and Doppler ultrasound measurement of the mean pulsatility index PI of the uterine arteries
However this screening method can only predict a portion of patients who will develop preeclampsia before 37 weeks and who may benefit from aspirin intake if administered at doses 100mg and before 16 weeks Predicting and effectively preventing preeclampsia that occurs after 37 weeks remains the subject of debate and scientific research
Among emerging etiopathogenetic hypotheses numerous scientific publications suggest that alterations in maternal immunity and immune tolerance are the basis of hypertensive disorders in pregnancy Recent discoveries suggest that changes in maternal intestinal microbiota may underlie these immune alterations Alterations in gut microbiota diversity and composition known as dysbiosis can influence systemic immune responses and metabolic disturbances such as gestational diabetes and preeclampsia posing risks of metabolic alterations in the neonate
Based on these premises this study aims to define the characteristics of maternal intestinal microbiota in the two different clinical phenotypes of preeclampsia placental preeclampsia associated with growth restriction and metabolic-based preeclampsia associated with a fetus of appropriate weight for gestational age
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