Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03067298
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2017-01-18
Brief Title:
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Sponsor:
Emmanuel Bujold
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Status:
COMPLETED
Status Verified Date:
2022-03
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:
PREDICTION2
Brief Summary:
Preterm birth PTB preeclampsia PE fetal growth restriction FGR and intra-uterine fetal death IUFD constitutes the main causes of perinatal morbidity and mortality and are called Great Obstetrical Syndromes Algorithms to predict those outcomes have been developed by combining maternal characteristics history age BMI blood pressure biochemical sFlt-1 β-hCG PlGF AFP and sonographic uterine artery Doppler 3D of placenta cervical length nasal bone measurement nuchal translucency markers Another prospective observational study PREDICTION study NCT 02189148 is also ongoing which aims to validate those algorithms at the first trimester of pregnancy
Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates allowing closer monitoring of high-risk patients and potential therapeutics under investigation The current study PREDICTION2 is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes
Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates allowing closer monitoring of high-risk patients and potential therapeutics under investigation The current study PREDICTION2 is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes
Detailed Description:
The objective of this study is to validate the predictive values of biophysical maternal blood pressure biochemical sFlt-1 β-hCG PlGF and AFP and ultrasonographic cervical length Doppler 3D evaluation of the placenta 3D nasal bone biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth preeclampsia fetal growth restriction and intra-uterine fetal death
These biomarkers will be evaluated at 14-16 weeks 20-24 weeks and 30-34 weeks Those specific gestational ages have been selected because they correspond to the typical clinicalhospital visits for prenatal blood andor ultrasound screening
These biomarkers will be evaluated at 14-16 weeks 20-24 weeks and 30-34 weeks Those specific gestational ages have been selected because they correspond to the typical clinicalhospital visits for prenatal blood andor ultrasound screening
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