Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05034861
Status:
RECRUITING
Last Update Posted:
2022-12-15
First Post:
2021-08-13
Brief Title:
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR COSMOS Study
Sponsor:
Institute of Mother and Child Warsaw Poland
Organization:
Institute of Mother and Child Warsaw Poland
Study Overview
Official Title:
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR Study Protocol for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-12
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:
COSMOS
Brief Summary:
Fetal growth restriction is one of the major causes of perinatal morbidity mortality and adverse neurological outcome Growth restricted fetuses do not reach their potential due to multiple factors Although early 32 weeks gestation FGR is associated with the highest risk of adverse outcomes late FGR 32 weeks gestation is more common in daily maternal-fetal medicine care Despite its prevalence optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR COSMOS trial which is a prospective cross-over open-label and randomized trial that compares two different protocols for late-onset FGR observation
All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial Patients will be randomly divided into two groups CTG - a group that will receive electronic device for cCTG home assessment and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria Further management will depend on the arm of the study Pregnancy and neonatal outcomes will be collected and analyzed
All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial Patients will be randomly divided into two groups CTG - a group that will receive electronic device for cCTG home assessment and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria Further management will depend on the arm of the study Pregnancy and neonatal outcomes will be collected and analyzed
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