The Oslo Stan vs Lactate Observational Study

NCT04779294 | Completed

• 1 other identifier: 2017/1561
• Study Type: observational
• Target: 694
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Monitoring

Keywords

CTG; Fetal blood sampling - Lactate; ST waveform analysis

Outcome Measures

Primary Outcomes (2)

• 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

  1. Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia (i.e.umbilical artery blood pH ≤7.1) 2. 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) 3. 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

Study Arms (2)

Fetus in labour at risk of acedimia

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

Fetus in labour at risk of acedemia with STAN analysis

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

Interventions

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.

Fetus in labour at risk of acedemia with STAN analysis; Fetus in labour at risk of acedimia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only women who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (3)

• Berge MB, Kessler J, Staff AC, Jacobsen AF. The diagnostic accuracy of different fetal blood sample lactate cutoffs in labor, utilizing the StatStrip Xpress(R) lactate-meter: A population-based observational study. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1496-1504. doi: 10.1111/aogs.15140. Epub 2025 Apr 30.

  PMID: 40304212 DERIVED

• Berge MB, Jacobsen AF, Yli BM, Staff AC, Gunnes N, Falk RS, Helgadottir LB, Kessler J. A direct comparison of the diagnostic accuracy of ST segment analysis (STAN) and fetal scalp blood sample lactate: A population-based observational study. Eur J Obstet Gynecol Reprod Biol. 2025 Apr 17;308:147-152. doi: 10.1016/j.ejogrb.2025.03.002. Epub 2025 Mar 3.

  PMID: 40054097 DERIVED

• Berge MB, Kessler J, Yli BM, Staff AC, Gunnes N, Jacobsen AF. Neonatal outcomes associated with time from a high fetal blood lactate concentration to operative delivery. Acta Obstet Gynecol Scand. 2023 Aug;102(8):1106-1114. doi: 10.1111/aogs.14597. Epub 2023 Jun 7.

  PMID: 37287317 DERIVED

Study Officials

• Jacobsen F Anne Flem, MD, PhD

  OUH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, dpt of Obstetrics, Prof II University of Oslo

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: March 3, 2021
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: October 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)