Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05606497
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2022-10-24
Brief Title:
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction the OPTICORE Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction the OPTICORE Study
Status:
RECRUITING
Status Verified Date:
2022-10
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:
OPTICORE
Brief Summary:
The aim of this observational study is to optimize the timing of antenatal corticosteroids administered to patients with pregnancies complicated by early-onset fetal growth restriction in order to reduce neonatal morbidity and mortality In the Netherlands two main timing strategies of antenatal corticosteroids are commonly practiced In this study the investigators will compare these two timing strategies regarding CCS administration in early-onset FGR on the combined endpoint of perinatal neonatal and in-hospital mortality In addition the investigators aim to develop a dynamic prediction tool a novel technique in prediction research to predict the time-interval in days until delivery within this population With that the investigators aim to reduce neonatal morbidity and mortality for future FGR pregnancies
Detailed Description:
None
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