NCT04779294

The Oslo Stan vs Lactate Observational Study

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
• Phase: —
• Study type: Observational
• Enrollment: 694 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Fetal Monitoring

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	STAN ( St wave analysis) and fetal blood sample-lactate	The CTG will be analysed by an expert group additional to the standard procedure that have been done in Labour already. The STAN analysis will be decrypted/ demasked anonymously by the Company producing these machines.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-12-31
• Completion: 2023-10-31
• First posted: 2021-03-03
• Last updated: 2023-12-04

Locations

1 site across 1 country: Norway