Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465634
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2007-04-24
Brief Title:
Doppler and Biological Second Trimester Placental Insufficiency Screening
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids
Status:
COMPLETED
Status Verified Date:
2013-08
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:
ARTULEP
Brief Summary:
To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age SGA fetuses at 20-24 weeks of gestation
Detailed Description:
Pre-eclampsia PE and intrauterine growth restriction IUGR are known as major factors in perinatal morbidity and mortality Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention
Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased risk has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy Studies have reported detection rate of 50-70 for a 5 false positive rate in women developing early pre-eclampsia
A variety of proteins and hormones have been studied as potential markers for pre-eclampsia Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia However screening performance of leptin detection in early pregnancy has never been assessed
Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency
Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased risk has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy Studies have reported detection rate of 50-70 for a 5 false positive rate in women developing early pre-eclampsia
A variety of proteins and hormones have been studied as potential markers for pre-eclampsia Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia However screening performance of leptin detection in early pregnancy has never been assessed
Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency
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