The Oslo Stan vs Lactate Observational Study

Fetal Monitoring Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779294
• Other study ID #: 2017/1561
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 694
• Est. completion date: October 31, 2023
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy
• Cephalic presentation
• Gestational age =36+0 weeks at delivery
• Presence of antpartum or intrapartum risk factors for fetal hypoxia according to Norwegian guidelines and therefore indication for electronic fetal monitoring with scalp electrode .

Exclusion Criteria:

• Multiple pregnancies
• Breech presentation
• Gestational age < 36+0 weeks
• Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)

Related Conditions & MeSH terms

• Fetal Monitoring

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is fetal hypoxia (defined as arterial umbilical cord pH < 7,1 postpartum) superiorly identified by fetal scalp blood sampling (lactate) or ST analysis of fetal ECG	Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia (i.e.umbilical artery blood pH =7.1); Compare FBS lactate with STAN in order to identify the superior method to avoid cord-blood acidosis at birth (i.e.umbilical artery blood pH >7.1); Compare the true negative alerts from both methods, specificity	2019-2022
Primary	Is cord blood acidosis, measured as pH in the umbilical artery postpartum affected by the "Decision-to-delivery interval" measured in minutes from Lactate warning until delivery.	To assess the effect of increasing time interval from the objective warning of intrapartum fetal hypoxia with fetal scalp lactate = 4.8mmol/l to the end of operative delivery on the percentage of moderate cord-blood acidosis at birth (i.e., umbilical artery blood pH = 7.1)	2019-2022