Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-01 @ 7:18 PM
Study NCT ID:
NCT03590951
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2018-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 771}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstetric complications', 'timeFrame': 'From beginning to end of cesarean section (2 hours)', 'description': 'Perioperative bleeding'}], 'secondaryOutcomes': [{'measure': 'Anesthetic complications', 'timeFrame': 'From beginning to end of cesarean section (2 hours)', 'description': 'Failed epidural'}, {'measure': 'Neonatal complications', 'timeFrame': '1 and 5 minutes after delivery', 'description': 'Apgar scores'}, {'measure': 'Other anesthetic complications', 'timeFrame': 'From beginning to end of cesarean section (2 hours)', 'description': 'Intraoperative hypotension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbid Obesity', 'Cesarean Section Complications', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in morbidly obese pregnant patients who underwent cesarean delivery at Augusta University Medical Center, during a 2-year period (2015-2016).', 'detailedDescription': 'This study compared non-obese, obese and morbidly obese patients with respect to maternal, perinatal and anesthetic outcomes. Obstetric aspects included emergent procedure, estimated blood loss, obstetric complications, maternal disposition, length of stay and in-hospital mortality. Neonatal aspects included Apgar scores. Anesthetic aspects included anesthetic technique, intraoperative hemodynamic instability, failed regional anesthesia and anesthetic complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients who underwent cesarean section at Augusta University Medical Center.\n* Patients older than 18 years.\n\nExclusion Criteria:\n\n* Gestational age \\<37 weeks.\n* Patients with chronic pain conditions'}, 'identificationModule': {'nctId': 'NCT03590951', 'briefTitle': 'Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience', 'orgStudyIdInfo': {'id': '1053583'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrospective chart review', 'type': 'OTHER', 'description': 'A retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Efrain Riveros Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Georgia. Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Department of Anesthesiology and Perioperative Medicine', 'investigatorFullName': 'Efrain Riveros Perez, MD', 'investigatorAffiliation': 'Augusta University'}}}}