The Oslo Stan vs Lactate Observational Study

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Fetal Monitoring

Intervention / Treatment
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* Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fetus in labour at risk of acedimia<br>The Group of patients studied are fetuses in labour at risk of hypoxia with internal fetal monitoring and scalp lactate bloodsamples ( standard monitoring). | Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate<br>* 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.<br>|
| Fetus in labour at risk of acedemia with STAN analysis<br>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) | Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTG, Fetal blood sampling - Lactate, ST waveform analysis