Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00330512
Status:
TERMINATED
Last Update Posted:
2009-06-30
First Post:
2006-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-28', 'studyFirstSubmitDate': '2006-05-25', 'studyFirstSubmitQcDate': '2006-05-25', 'lastUpdatePostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['regional anestesia', 'cesarean section', 'hypotention', 'newborn'], 'conditions': ['Elective Cesarean Section', 'Maternal Hypotention']}, 'descriptionModule': {'briefSummary': 'About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.\n\nNo studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.', 'detailedDescription': 'A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.\n\nData will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).\n\nInfant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fullterm infants, born by elective cesarean section using regional anasthesia.\n\nExclusion Criteria:\n\n* preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.'}, 'identificationModule': {'nctId': 'NCT00330512', 'briefTitle': 'Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.', 'orgStudyIdInfo': {'id': 'SHEBA-06-4117-AM-CTIL'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ayala Maayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ayala Maayan', 'oldOrganization': 'Sehba Medical Center'}}}}