Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-23 @ 3:31 PM
Study NCT ID:
NCT04657692
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2020-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D020816', 'term': 'Amino Acid Motifs'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000072416', 'term': 'Protein Structural Elements'}, {'id': 'D011487', 'term': 'Protein Conformation'}, {'id': 'D008968', 'term': 'Molecular Conformation'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D017433', 'term': 'Protein Structure, Secondary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': 'intraoperative period to 24 hours postoperative', 'description': 'Incidence of maternal complications associated with anesthesia'}], 'secondaryOutcomes': [{'measure': 'Incidence of obstetric-related complications', 'timeFrame': 'intraoperative period to 24 hours postoperative', 'description': 'Incidence of maternal complicaitions associated with obstetrics eg. amount of hemorrhage, rate of hysterectomy, rate of blood transfusion'}, {'measure': 'Neonatal outcomes', 'timeFrame': 'Neonate apgar score at 1-min and 5 min', 'description': 'Neonate apgar score (ranging 0-10)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthetic complications', 'maternal outcomes', 'neonatal outcomes', 'cesarean section', 'obesity'], 'conditions': ['Cesarean Section Complications', 'Anesthesia Complication', 'Obesity, Morbid']}, 'referencesModule': {'references': [{'pmid': '36947155', 'type': 'RESULT', 'citation': 'Nivatpumin P, Lertbunnaphong T, Maneewan S, Vittayaprechapon N. Comparison of perioperative outcomes and anesthetic-related complications of morbidly obese and super-obese parturients delivering by cesarean section. Ann Med. 2023 Dec;55(1):1037-1046. doi: 10.1080/07853890.2023.2187877.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.\n\nObesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.\n\nThe aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND.', 'detailedDescription': 'The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.\n\nObesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.\n\nWHO categorised obesity into 3 classification; grade 1: BMI 30-34.9 kg/m2, grade 2: BMI 35-39.9 kg/m2, grade 3: BMI \\> 40 kg/m2. This study emphasised in grade 3 obese pregnant women (BMI\\>40 kg/m2) undergoing cesarean delivery that were at risk of increasing in anesthetic complications such as airway complications as well as complications derived from regional anesthesia eg. high spinal block, failed spinal block etc.\n\nTherefore, the primary objective of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND. The secondary objectives rate of postpartum haemorrhage, rate of hysterectomy and neonatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese pregnant women whose body mass index (BMI\\>,= 40 kg/m2) underwent cesarean delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women BMI\\>,= 40 kg/m2 underwent cesarean delivery\n\nExclusion Criteria:\n\n* Patients with gestational age \\<,= 24 weeks\n* Patients with death fetus in Utero\n* Multiple gestation\n* Patients with intrapelvic cavity pathology eg. myoma uteri\n* Patients with abnormal placentation\n* Patients with polyhydramnios'}, 'identificationModule': {'nctId': 'NCT04657692', 'briefTitle': 'Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery- a Retrospective Review', 'orgStudyIdInfo': {'id': '873/2562 (EC2)'}, 'secondaryIdInfos': [{'id': 'Si 125/2020', 'type': 'OTHER', 'domain': 'Siriraj Institutional Review Board'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Anesthesia; general or regional', 'type': 'PROCEDURE', 'description': 'General anesthesia: general anesthesia with endotracheal tube Regional anesthesia: spinal anesthesia, epidural anesthesia, combined spinal epidural anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Patchareya Nivatpumin', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}