Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
694 participants
OBSERVATIONAL
2018-09-01
2023-10-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
STAN ( St wave analysis) and fetal blood sample-lactate
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
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)
STAN ( St wave analysis) and fetal blood sample-lactate
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.
Interventions
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STAN ( St wave analysis) and fetal blood sample-lactate
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Breech presentation
* Gestational age \< 36+0 weeks
* Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)
18 Years
60 Years
FEMALE
Yes
Sponsors
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Haukeland University Hospital
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Anne Flem Jacobsen
Senior Consultant, dpt of Obstetrics, Prof II University of Oslo
Principal Investigators
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Jacobsen F Anne Flem, MD, PhD
Role: STUDY_DIRECTOR
OUH
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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2017/1561
Identifier Type: -
Identifier Source: org_study_id