Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 2:11 PM
Study NCT ID:
NCT05427968
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hypotension During Spinal Anaesthesia for C-section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group 1 - Supine Group', 'timeFrame': 'December 2021 to February 2022', 'description': 'Systolic blood pressures decreased significantly in the supine group'}, {'measure': 'Group 2 - Left tilt Group', 'timeFrame': 'December 2021 to February 2022', 'description': 'The decrease in the diastolic blood pressure was marginally significant in the left tilt group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypotension', 'Cesarean Section', 'Aortocaval Compression', 'Left titl'], 'conditions': ['Hypotension', 'Cesarean Section', 'Aortocaval Compression']}, 'descriptionModule': {'briefSummary': 'Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.', 'detailedDescription': 'C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block.\n\nThe aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).', 'genderDescription': 'Only females included undergoing C-section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.\n\nExclusion Criteria:\n\n* Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index \\> 30 kg.m2), intrauterine growth were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05427968', 'briefTitle': 'Comparison of Hypotension During Spinal Anaesthesia for C-section', 'organization': {'class': 'OTHER', 'fullName': 'Rawalpindi Medical College'}, 'officialTitle': 'To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section', 'orgStudyIdInfo': {'id': '2021-4711-17843'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Supine group', 'description': 'Spinal anaesthesia was administered in sitting position and then supine position was maintained.'}, {'label': 'Left tilt group', 'description': 'Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Rawalpindi Medical University', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rawalpindi Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MBBS', 'investigatorFullName': 'Rubaid Azhar Dhillon', 'investigatorAffiliation': 'Rawalpindi Medical College'}}}}