Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04779294
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oslo Stan vs Lactate Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 694}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '1. Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia (i.e.umbilical artery blood pH ≤7.1)\n2. 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)\n3. Compare the true negative alerts from both methods, specificity'}, {'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', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTG', 'Fetal blood sampling - Lactate', 'ST waveform analysis'], 'conditions': ['Fetal Monitoring']}, 'referencesModule': {'references': [{'pmid': '40304212', 'type': 'DERIVED', 'citation': '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': '40054097', 'type': 'DERIVED', 'citation': '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': '37287317', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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\n\n* Study the relationship between the decision-to-delivery interval and neonatal morbidity in deliveries monitored by scalp lactate measurement\n* Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia\n* Compare the false negative alerts from both methods\n* Explore the temporal and quantitative relation between fetal lactate metabolism and ST interval changes of the fetal ECG'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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.', 'genderDescription': 'Only women who are pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy\n* Cephalic presentation\n* Gestational age ≥36+0 weeks at delivery\n* Presence of antpartum or intrapartum risk factors for fetal hypoxia according to Norwegian guidelines and therefore indication for electronic fetal monitoring with scalp electrode .\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Breech presentation\n* Gestational age \\< 36+0 weeks\n* Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)'}, 'identificationModule': {'nctId': 'NCT04779294', 'briefTitle': 'The Oslo Stan vs Lactate Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2017/1561'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetus in labour at risk of acedimia', 'description': 'The Group of patients studied are fetuses in labour at risk of hypoxia with internal fetal monitoring and scalp lactate bloodsamples ( standard monitoring).', 'interventionNames': ['Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate']}, {'label': 'Fetus in labour at risk of acedemia with STAN analysis', 'description': '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)', 'interventionNames': ['Diagnostic Test: STAN ( St wave analysis) and fetal blood sample-lactate']}], 'interventions': [{'name': 'STAN ( St wave analysis) and fetal blood sample-lactate', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Fetus in labour at risk of acedemia with STAN analysis', 'Fetus in labour at risk of acedimia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jacobsen F Anne Flem, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant, dpt of Obstetrics, Prof II University of Oslo', 'investigatorFullName': 'Anne Flem Jacobsen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}