Clinical trial NCT04779294: The Oslo Stan vs Lactate Observational Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Monitoring
Keywords: CTG
Fetal blood sampling - Lactate
ST waveform analysis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2021-03-03
Enrollment: 694
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women in labour who are monitored with CTG and FBS scalp lactate. CTG monitoring is achieved by an internal scalp electrode combined with a pressure-sensitive external contraction transducer. FBS is performed at the decision of the obstetrician. Capillary blood is obtained from the fetal head and analyzed with a bed-side test (Lactate Pro). The monitoring procedures described above are identical with the current clinical routine at the department.

The department utilizes S31 fetal monitors (Neoventa Medical AB©, Sweden), which are equipped with the hard and software tool for ST analysis. Once the scalp electrode is attached, ST analysis will be performed and recorded continuously. ST information is blinded in labor, i.e. clinical management will only be based on CTG and FBS if indicated.

Brief 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

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 2019-2022
measure: 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.
timeFrame: 2019-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: OUH
name: Jacobsen F Anne Flem, MD, PhD
role: STUDY_DIRECTOR
References: