Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 7:11 PM
Study NCT ID:
NCT01708668
Status:
UNKNOWN
Last Update Posted:
2015-01-15
First Post:
2012-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2012-10-07', 'studyFirstSubmitQcDate': '2012-10-15', 'lastUpdatePostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal oral and tympanic temperature', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)'}], 'secondaryOutcomes': [{'measure': 'Maternal serum Interleukin-1β', 'timeFrame': 'At time of placental delivery and 3, 6 and 12 hours later'}, {'measure': 'Cord serum Interleukin-1β', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Maternal serum Interleukin-6', 'timeFrame': 'At time of placental delivery and 3, 6 and 12 hours later'}, {'measure': 'Cord serum Interleukin-6', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Maternal serum Interleukin-10', 'timeFrame': 'At time of placental delivery and 3, 6 and 12 hours later'}, {'measure': 'Cord serum Interleukin-10', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Maternal serum tumor necrosis factor-α', 'timeFrame': 'At time of placental delivery and 3, 6 and 12 hours later'}, {'measure': 'Cord serum tumor necrosis factor-α', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Regression and correlation analyses between maternal and cord serum cytokines', 'timeFrame': 'At twelve hours postpartum'}, {'measure': 'Placental routine pathologic examination', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Maternal and cord blood gase analysis', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Maternal modified Bromage scale and visual analogue scale', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)'}, {'measure': 'Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture', 'timeFrame': 'At two hours postpartum'}, {'measure': 'Rates of cesarean delivery and instrument-assisted delivery', 'timeFrame': 'At time of placental delivery'}, {'measure': 'Indications of cesarean delivery', 'timeFrame': 'Initiation of analgesia to placental delivery (approximately 8 hours)'}, {'measure': 'Duration of analgesia', 'timeFrame': 'Initiation of analgesia to 2 h postpartum (approximately 10 hours)'}, {'measure': 'Durations of labor stages', 'timeFrame': 'From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)'}, {'measure': 'Maternal satisfaction with analgesia', 'timeFrame': 'At two hours postpartum'}, {'measure': 'Use of oxytocin after analgesia', 'timeFrame': 'At twenty-four hours postpartum'}, {'measure': 'Low back pain at 3 months after vaginal delivery', 'timeFrame': 'At the third month after vaginal delivery'}, {'measure': 'Breastfeeding success at 6 weeks after vaginal delivery', 'timeFrame': 'At the sixth week after successful delivery'}, {'measure': 'Neonatal Apgar scale', 'timeFrame': 'At the first and fifth minutes after baby was born'}, {'measure': 'Incidence of maternal side effects', 'timeFrame': 'Initiation of analgesia to 2 hour postpartum (approximately 10 hours)'}, {'measure': 'Neonatal Neurologic and Adaptive Capacity Score', 'timeFrame': 'At 30 min, 2 h, and 24 h after baby was born'}, {'measure': 'Maximal oxytocin dose', 'timeFrame': 'At twenty-four hours postpartum'}, {'measure': 'Neonatal sepsis evaluation', 'timeFrame': 'At 30 min after baby was born'}, {'measure': 'Neonatal antibiotic treatment', 'timeFrame': 'One week after baby was born'}, {'measure': 'Maternal heart rate, respiratory rate, and blood pressure', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)'}, {'measure': 'Highest thoracic sensory level to alcohol', 'timeFrame': 'At three hours after initiation of analgesia'}, {'measure': 'Uterine contraction', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)'}, {'measure': 'Neonatal rectal temperature', 'timeFrame': 'At delivery, 30 min after delivery, and 1 h after delivery'}, {'measure': 'Fetal heart rate', 'timeFrame': 'From initiation of analgesia to delivery (approximately 8 hours)'}, {'measure': 'Maternal group B streptococcus (GBS) colonization', 'timeFrame': 'At time of initiation of analgesia'}, {'measure': 'Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured', 'timeFrame': 'From initiation of analgesia to delivery (approximately 8 hours)'}, {'measure': 'Neonatal weight', 'timeFrame': 'At delivery'}, {'measure': 'Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)'}, {'measure': 'Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)'}, {'measure': 'Maternal postpartum depression', 'timeFrame': 'At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fever', 'Patient controlled epidural analgesia', 'Labor analgesia', 'Epidural analgesia', 'Combined spinal-epidural analgesia'], 'conditions': ['Labor Pain', 'Pain', 'Neurologic Manifestations', 'Signs and Symptoms', 'Pathological Conditions, Signs and Symptoms']}, 'descriptionModule': {'briefSummary': 'Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. However, the optimal combination of bolus volume and administrating interval has not yet been compared. The purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women\n* Required labor analgesia\n* Chinese\n* Spontaneous labor\n\nExclusion Criteria:\n\n* Contraindications for epidural analgesia\n* Allergic to opioids and/or local anesthetics\n* Failed to performing epidural catheterization\n* Organic dysfunction\n* Those who were not willing to or could not finish the whole study at any time\n* Using or used in the past 14 days of the monoamine oxidase inhibitors\n* Alcohol addictive or narcotic dependent patients\n* Subjects with a nonvertex presentation or scheduled induction of labor\n* Twin gestation and breech presentation'}, 'identificationModule': {'nctId': 'NCT01708668', 'acronym': 'EIEBFLA', 'briefTitle': 'The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women', 'orgStudyIdInfo': {'id': 'NJMCHH-2012-A010'}, 'secondaryIdInfos': [{'id': '08NMUM063', 'type': 'OTHER_GRANT', 'domain': 'Nanjing Medical University'}, {'id': 'YKK08119', 'type': 'OTHER_GRANT', 'domain': 'Nanjing Department of Health'}, {'id': 'YKK11058', 'type': 'OTHER_GRANT', 'domain': 'Nanjing Department of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Epidural analgesia (EA) with continuous epidural infusion(CEI)', 'interventionNames': ['Procedure: Epidural analgesia', 'Procedure: Continuous epidural infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)', 'interventionNames': ['Procedure: Combined spinal-epidural analgesia', 'Procedure: Continuous epidural infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)', 'interventionNames': ['Procedure: Epidural analgesia', 'Procedure: Intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)', 'interventionNames': ['Procedure: Epidural analgesia', 'Procedure: Intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)', 'interventionNames': ['Procedure: Epidural analgesia', 'Procedure: Intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': 'Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)', 'interventionNames': ['Procedure: Combined spinal-epidural analgesia', 'Procedure: Intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7', 'description': 'Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)', 'interventionNames': ['Procedure: Combined spinal-epidural analgesia', 'Procedure: Intermittent epidural bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '8', 'description': 'Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)', 'interventionNames': ['Procedure: Combined spinal-epidural analgesia', 'Procedure: Intermittent epidural bolus']}], 'interventions': [{'name': 'Epidural analgesia', 'type': 'PROCEDURE', 'armGroupLabels': ['1', '3', '4', '5']}, {'name': 'Combined spinal-epidural analgesia', 'type': 'PROCEDURE', 'armGroupLabels': ['2', '6', '7', '8']}, {'name': 'Continuous epidural infusion', 'type': 'PROCEDURE', 'armGroupLabels': ['1', '2']}, {'name': 'Intermittent epidural bolus', 'type': 'PROCEDURE', 'armGroupLabels': ['3', '4', '5', '6', '7', '8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanwu Feng, M.D.', 'role': 'CONTACT', 'email': 'shanwufeng@163.com', 'phone': '+86 25 52226112'}, {'name': 'Shanwu Feng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Shanwu Feng, M.D.', 'role': 'CONTACT', 'email': 'shanwufeng@163.com', 'phone': '+86 25 52226112'}], 'overallOfficials': [{'name': 'Shanwu Feng, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShanWu Feng, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004', 'investigatorFullName': 'ShanWu Feng, M.D.', 'investigatorAffiliation': 'Nanjing Medical University'}}}}