Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02379494
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2014-02-20
Brief Title:
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction
Sponsor:
Fetal Medicine Foundation
Organization:
Fetal Medicine Foundation
Study Overview
Official Title:
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction Using Uterine Artery Doppler Maternal Blood Pressure Maternal Characteristics Placental Volume and Maternal Serum Factors
Status:
COMPLETED
Status Verified Date:
2016-02
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:
None
Brief Summary:
To evaluate the feasibility of screening for preeclampsia and fetal growth restriction between 11-136 weeks gestation utilizing the combination of uterine artery doppler maternal blood pressure maternal characteristics placental volume and maternal serum factors including PAPPA-A PLGF AFP and free Beta HCG This is a non interventional study
Detailed Description:
Preeclampsia PE is a condition which affects approximately 2 of all pregnancies and can be a major cause of maternal and perinatal morbiditymortality 2 The suspected underlying mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral arteries leading to impaired placental perfusion placental ischemia and subsequent development of endothelial dysfunction 3 There is evidence that PE which is commonly associated with fetal growth restriction can be predicted effectively at 11-13 weeks gestational age by combined screening algorithms combining uterine artery pulsatility index PI maternal mean arterial pressure MAP and maternal serum concentrations of placental products including but not limited to plasma protein A PAPP-A and placental growth factor PLGF 4-6
Aim of StudyHypothesis
The aim of this study is to develop an algorithm based on the combination of maternal factors uterine artery pulsatility index mean arterial pressure placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population
Aim of StudyHypothesis
The aim of this study is to develop an algorithm based on the combination of maternal factors uterine artery pulsatility index mean arterial pressure placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population
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