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Completed

NCT Number: NCT04779294

The Oslo Stan vs Lactate Observational Study

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.

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Key information

Conditions

Fetal Monitoring

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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
  • Investigate the occurrence of fetal extrasystoles during labor and to assess their association with short-term neonatal outcomes

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. 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

    Time frame: 2019-2022

    • 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

  2. 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.

    Time frame: 2019-2022

    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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
Mar 3, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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