Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01110005
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial of Intravenous Fluids During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsl1@psu.edu', 'phone': '717-531-6210', 'title': 'Richard S. Legro, M.D.', 'organization': 'Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "From onset of labor through the mother's hospital stay", 'description': 'Adverse event information was collected via review of medical charts.', 'eventGroups': [{'id': 'EG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 2, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 9, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Postpartum hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Congenital anomalies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'OG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.3', 'estimateComment': 'D5LR vs. LR', 'statisticalMethod': 'Regression, log binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The regression model adjusted for site of recruitment as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare c-section rates between the D5LR and LR treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxytocin Augmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'OG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'D5LR vs. LR', 'statisticalMethod': 'Regression, log binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The regression model adjusted for site of recruitment as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare augmentation rates between the D5LR and LR treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'OG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '18.3'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '18.0'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'This method was used to control for site of recruitment'}], 'paramType': 'MEDIAN', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare time to delivery between the D5LR and LR treatment groups', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'FG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'missing consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'D5 Lactated Ringers Solution (D5LR)', 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'BG001', 'title': 'Lactated Ringers Solution (LR)', 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 318 subjects were randomized for the study but nine were excluded from analysis entirely: 3 were deemed ineligible, 5 did not have adequate documentation of informed consent, and 1 subject withdrew consent.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2010-04-09', 'resultsFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-24', 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-Section', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare c-section rates between the D5LR and LR treatment groups'}], 'secondaryOutcomes': [{'measure': 'Oxytocin Augmentation', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare augmentation rates between the D5LR and LR treatment groups'}, {'measure': 'Time to Delivery', 'timeFrame': 'From onset of labor to delivery', 'description': 'Compare time to delivery between the D5LR and LR treatment groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['D5LR', 'glucose containing IV solution', 'LR', 'non glucose IV solution'], 'conditions': ['Ketosis']}, 'referencesModule': {'references': [{'pmid': '25758624', 'type': 'DERIVED', 'citation': 'Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.', 'detailedDescription': 'This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery.\n\nThe primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.\n2. These women will be in good health and candidates for vaginal delivery.\n\nExclusion Criteria:\n\n1. Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.\n2. Patients presenting for induction of labor or requiring induction upon admission.\n3. Patients presenting for scheduled cesarean section.\n4. Patients with any form of diabetes or glucose dysregulation condition.\n5. Concurrent use of steroids.\n6. Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).\n7. Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).'}, 'identificationModule': {'nctId': 'NCT01110005', 'acronym': 'RARHY', 'briefTitle': 'A Trial of Intravenous Fluids During Labor', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor', 'orgStudyIdInfo': {'id': '32118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "D5 Lactated Ringer's solution (D5LR)", 'description': 'IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.', 'interventionNames': ["Other: D5 Lactated Ringer's Solution (D5LR)"]}, {'type': 'ACTIVE_COMPARATOR', 'label': "Lactated Ringer's solution (LR)", 'description': 'Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.', 'interventionNames': ["Other: Lactated Ringer's Solution (LR)"]}], 'interventions': [{'name': "D5 Lactated Ringer's Solution (D5LR)", 'type': 'OTHER', 'description': 'D5LR IV fluid', 'armGroupLabels': ["D5 Lactated Ringer's solution (D5LR)"]}, {'name': "Lactated Ringer's Solution (LR)", 'type': 'OTHER', 'description': 'LR IV fluid', 'armGroupLabels': ["Lactated Ringer's solution (LR)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '17901', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St. Luke Hospital', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Penn State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19611', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}], 'overallOfficials': [{'name': 'Richard S Legro, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States'}, {'name': 'John Smulian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Valley Hospital, Allentown, Pennsylvania, United States'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lehigh Valley Hospital', 'class': 'OTHER'}, {'name': 'The Reading Hospital and Medical Center', 'class': 'OTHER'}, {'name': "St. Luke's Hospital, Pennsylvania", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Obstetrics and Gynecology and Public Health Sciences', 'investigatorFullName': 'Richard S. Legro, M.D.', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}