Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00634855
Status:
TERMINATED
Last Update Posted:
2018-06-15
First Post:
2008-02-19
Brief Title:
Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR
Status:
TERMINATED
Status Verified Date:
2018-06
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:
None
Brief Summary:
The objective of this study is to determine whether there are alterations in the population of endothelial progenitor cells in umbilical cord blood samples of infants born in the setting of maternal preeclampsia or fetal growth restriction
Detailed Description:
Preeclampsia remains a significant cause of neonatal and maternal morbidity and mortality This disorder is found in 5-7 of pregnancies and its incidence is increased in gravid patients with multiple gestations chronic hypertension renal disease autoimmune disease and at extremes of maternal age It is responsible for 15 of preterm births which is accompanied by a resultant increase in neonatal morbidity and mortality In developing countries it is responsible for approximately 50000 maternal deaths each year No widespread intervention to prevent this disease has been found effective and the only effective treatment remains delivery of the fetus
To date the cause of preeclampsia is not known although many agree that preeclampsia is a two-stage disease as described by Roberts et al with the placenta of central importance The first stage involves poor placental perfusion usually a result of impaired vascular remodeling in early pregnancy or from maternal disease This leads to the second stage which is the maternal syndrome of preeclampsia and involves both endothelial and leukocyte activation
Preeclampsia is associated with an increased maternal cardiovascular risk later in life Women with a history of preeclampsia demonstrate altered expression of angiogenesis-related proteins and increased insulin resistance as measured by the homeostasis model of insulin resistance Additionally preeclampsia is associated with an increase in future cardiovascular risk in the fetus
Endothelial dysfunction and abnormal regulation of vascular tone that is present in preeclampsia suggests abnormal development of vascular cells such as endothelial progenitor cells The increased cardiovascular risk of neonates born in the setting of IUGR and preeclampsia also suggests the possibility of abnormal development of endothelial progenitor cells in the fetal compartment in these disease states The purpose of this pilot project is to determine the effects of preeclampsiaIUGR on endothelial progenitor cells derived from fresh umbilical cord blood
To date the cause of preeclampsia is not known although many agree that preeclampsia is a two-stage disease as described by Roberts et al with the placenta of central importance The first stage involves poor placental perfusion usually a result of impaired vascular remodeling in early pregnancy or from maternal disease This leads to the second stage which is the maternal syndrome of preeclampsia and involves both endothelial and leukocyte activation
Preeclampsia is associated with an increased maternal cardiovascular risk later in life Women with a history of preeclampsia demonstrate altered expression of angiogenesis-related proteins and increased insulin resistance as measured by the homeostasis model of insulin resistance Additionally preeclampsia is associated with an increase in future cardiovascular risk in the fetus
Endothelial dysfunction and abnormal regulation of vascular tone that is present in preeclampsia suggests abnormal development of vascular cells such as endothelial progenitor cells The increased cardiovascular risk of neonates born in the setting of IUGR and preeclampsia also suggests the possibility of abnormal development of endothelial progenitor cells in the fetal compartment in these disease states The purpose of this pilot project is to determine the effects of preeclampsiaIUGR on endothelial progenitor cells derived from fresh umbilical cord blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None