Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04779294
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oslo Stan vs Lactate Observational Study
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
The Oslo Stan vs Lactate Observational Study, an Observational Study Were we Compare the Clinical Performance of Two Adjunctive Methods to CTG in Intrapartum Fetal Monitoring
Status:
COMPLETED
Status Verified Date:
2023-12
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:
None
Brief Summary:
The main aim of the study is to compare the clinical performance of two adjunctive methods to CTG in intrapartum fetal monitoring: FBS with measurement of scalp lactate and ST analysis of the fetal ECG.
Detailed Description:
We use Lactate as a standard adjunctive method in our hospital but we have STAN software available ( is demasked) in our CTG monitors. We will include all women in labour with an intern scalp monitoring and analyse the CTG, the lactate samples and the STAN signals in the same patient and
* Study the relationship between the decision-to-delivery interval and neonatal morbidity in deliveries monitored by scalp lactate measurement
* Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia
* Compare the false negative alerts from both methods
* Explore the temporal and quantitative relation between fetal lactate metabolism and ST interval changes of the fetal ECG
* Study the relationship between the decision-to-delivery interval and neonatal morbidity in deliveries monitored by scalp lactate measurement
* Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia
* Compare the false negative alerts from both methods
* Explore the temporal and quantitative relation between fetal lactate metabolism and ST interval changes of the fetal ECG
Study Oversight
Has Oversight DMC:
False
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?: