Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06010238
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-07-21
Brief Title:
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
SAVEFGR
Brief Summary:
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe early-onset fetal growth restriction the use of STV analysis in fetal monitoring improves the chances of perinatal survival compared with visual evaluation of the cardiotocography
Detailed Description:
Severe early-onset fetal growth restriction FGR 32 weeks gestation is a condition in which the fetus does not reach its growth potential due to placental insufficiency This condition affects about 03 of pregnancies accounting for an estimated 15000 babies in Europe being born premature below 32 weeks gestation The main clinical dilemma of FGR lies in the timing of birth given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity death or survival with severe neurodevelopmental impairment The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency fetal size and growth Doppler ultrasound serum biomarkers and the early detection of progressive fetal hypoxia with cardiotocography CTG The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG A delicate balance exists between having the fetus born too early and facing the risks of extreme prematurity combined with a very low birthweight and between delivering the fetus too late when the fetus has the disadvantage of hypoxia at birth The decision when to deliver the fetus is made mostly based on the CTG The inter- and intra-observer variability could be overcome by software analysis according to the original DawesRedman algorithm The software calculates the short-term variation STV of the inter-beat interval expressed in milliseconds and a range of secondary calculations In contrast with repeated decelerations when fetal hypoxia is considered evident the place of the software analysis of the fetal heart rate variability is less clear Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes fetal death and long-term infant outcome
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe early-onset FGR
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe early-onset FGR
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