Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04074005
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2019-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2019-05-04', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cesarean delivery after epidural analgesia for labor', 'timeFrame': 'From epidural catheter insertion to delivery', 'description': 'Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain'}], 'secondaryOutcomes': [{'measure': 'Factors affecting rate of cesarean delivery after epidural analgesia for labor', 'timeFrame': 'at the time epidural catheter insertion', 'description': 'cervical dilatation before insertion epidural catheter (cm.)'}, {'measure': 'Efficacy of epidural analgesia for labor', 'timeFrame': 'before and after epidural catheter insertion', 'description': 'pain score (verbal rating scale pain score)'}, {'measure': 'Side effects of epidural analgesia for labor: nausea and vomiting', 'timeFrame': 'From epidural catheter insertion to delivery', 'description': 'nausea and vomiting (rating by patients: 0= no symptom, 1= nausea 2= vomiting)'}, {'measure': 'Side effects of epidural analgesia for labor: pruritus', 'timeFrame': 'From epidural catheter insertion to delivery', 'description': 'pruritus (0=no, 1=yes)'}, {'measure': 'Side effects of epidural analgesia for labor: numbness of legs', 'timeFrame': 'From epidural catheter insertion to delivery', 'description': 'numbness of legs (0=no, 1=yes)'}, {'measure': 'Side effects of epidural analgesia for labor: motor weakness', 'timeFrame': 'From epidural catheter insertion to delivery', 'description': 'Rate motor weakness by Bromage score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural analgesia', 'Labor pain', 'Cesarean section rate'], 'conditions': ['Cesarean Section', 'Epidural; Anesthesia']}, 'referencesModule': {'references': [{'pmid': '40609139', 'type': 'RESULT', 'citation': 'Nivatpumin P, Triyasunant N, Visalyaputra S, Lertbunnaphong T, Saenyasiri N. Incidence and associated factors of cesarean delivery following epidural analgesia for labor: A prospective cohort study at a Thai university hospital. Midwifery. 2025 Sep;148:104501. doi: 10.1016/j.midw.2025.104501. Epub 2025 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.', 'detailedDescription': 'Epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. Many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. Some papers revealed the increasing in the rate of cesarean delivery. The main reason is assume to be a failure to progress labor after epidural analgesia. However, the recent report from Cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. Various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication.\n\nThe rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women whom admitted in labor ward for delivering baby as well as accept to receive epidural analgesia for labor', 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>,= 18 years\n* Accept epidural analgesia for labor\n* ASA classification I-II\n\nExclusion Criteria:\n\n* Unable to communicate Thai'}, 'identificationModule': {'nctId': 'NCT04074005', 'briefTitle': 'Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor', 'orgStudyIdInfo': {'id': '020/2562 (EC4)'}}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}