The Oslo Stan vs Lactate Observational Study

University of Oslo (UIO)

Status: Completed

Conditions: Fetal Monitoring

Treatments: Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate

Study type: Observational

Funder types: Other

Identifiers

NCT04779294

2017/1561

Details and patient eligibility

About

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.

Full 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

Enrollment: 694 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

694 participants in 2 patient groups

Fetus in labour at risk of acedimia

Description:

The Group of patients studied are fetuses in labour at risk of hypoxia with internal fetal monitoring and scalp lactate bloodsamples ( standard monitoring).

Treatment:

Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate

Fetus in labour at risk of acedemia with STAN analysis

Description:

Same group of fetuses in labour at risk of hypoxia with internal fetal monitoring and STAN analysis(ST waveform analysis of the fetal electrocardiogram, opened after study inclusion finished)

Treatment:

Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate