Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05259202
Status:
UNKNOWN
Last Update Posted:
2022-02-28
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of serious metabolic acidosis', 'timeFrame': 'day 1', 'description': 'the incidence of serious metabolic acidosis (defined as pH \\< 7 and Bdecf \\> 12 mmol/L in the umbilical cord artery).'}], 'secondaryOutcomes': [{'measure': 'Number of the instrumental delivery', 'timeFrame': 'day 1', 'description': 'Apgar score'}, {'measure': 'Number of the neonatal outcome', 'timeFrame': 'day 1', 'description': 'admission to a neonatal ward'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serious metabolic acidosis', 'T segment analysis', 'Blood samples', 'instrumental delivery', 'Apgar score', 'admission to a neonatal ward'], 'conditions': ['Metabolic Acidosis']}, 'descriptionModule': {'briefSummary': "ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event.\n\nSo this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women monitored by STAN in active labour with singleton term fetus in cephalic presentation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* patient with labor monitoring by ST segment analysis (STAN) according to current guidelines\n* patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes\n\nExclusion criteria:\n\n* STAN guidelines not respected before installation and during work\n* misclassification of fetal heart rate\n* obstetrical complications during labor'}, 'identificationModule': {'nctId': 'NCT05259202', 'briefTitle': 'Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event', 'orgStudyIdInfo': {'id': 'RECHMPL22_0070'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'WALTZING Aude, resident', 'role': 'CONTACT', 'email': 'a-waltzingrenault@chu-montpellier.fr', 'phone': '663801641', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'WALTZING Aude, Resident', 'role': 'CONTACT', 'email': 'a-waltzingrenault@chu-montpellier.fr', 'phone': '663801641', 'phoneExt': '33'}, {'name': 'DUPORT-PERCIER Marie, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'WALTZING Aude', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}