Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-02 @ 2:15 PM
Study NCT ID:
NCT03178461
Status:
UNKNOWN
Last Update Posted:
2019-03-08
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Warmed Parenteral Fluids During Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization two 2 groups according to temperature of IV fluids. One group will receive room temperature fluids and the other group will receive body temperature fluids.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-07', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-06-04', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of the second stage of labor', 'timeFrame': 'up to 5 hours from complete cervical dilation', 'description': 'How much time did it take from complete cervical dilation to the delivery of the baby.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of perineal tears and episiotomies', 'timeFrame': 'immediately after vaginal birth', 'description': 'The prevalence of perineal tears and episiotomies that occurred during vaginal delivery'}, {'measure': 'Neonatal APGAR score', 'timeFrame': 'up to 5 minutes from delivery', 'description': 'Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.'}, {'measure': 'The rate of prolonged second stage', 'timeFrame': 'immediately after completion of the delivery.', 'description': 'The percentage of patients, in each group, that were defined with a prolonged second stage. The definition is more than 2 hours from complete cervical dilation until delivery of the baby in multipara patients and more than 3 hours from complete cervical dilation until delivery of the baby in nullipara patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caesarean Section', 'Delivery'], 'conditions': ['Delivery, Obstetric']}, 'descriptionModule': {'briefSummary': 'To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.', 'detailedDescription': 'Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Only females are pregnant. The baby can be of either sex', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies\n* term pregnancies\n* receiving parenteral fluids\n\nExclusion Criteria:\n\n* high order pregnancies\n* preterm pregnancies (before 37 weeks of gestation)\n* known fetal major anomaly\n* known fetal significant chromosomal/genetic abnormality'}, 'identificationModule': {'nctId': 'NCT03178461', 'briefTitle': 'The Effect of Warmed Parenteral Fluids During Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section', 'orgStudyIdInfo': {'id': '0049-17-MMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Room temperature parenteral fluids', 'description': 'This group will receive IV room temperature fluids, which is the standard of care.\n\nThe composition of the fluids given will be normal saline with 5% dextrose.'}, {'type': 'EXPERIMENTAL', 'label': 'Body temperature parenteral fluids', 'description': 'This group will receive IV warmed fluids, body temperature, which is the experimental intervention.\n\nThe composition of the fluids given will be normal saline with 5% dextrose.', 'interventionNames': ['Other: Body temperature parenteral fluids']}], 'interventions': [{'name': 'Body temperature parenteral fluids', 'type': 'OTHER', 'description': '2 study groups shall receive the same parenteral fluids but at different temperatures.', 'armGroupLabels': ['Body temperature parenteral fluids']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hanoch Schreiber, MD', 'role': 'CONTACT', 'email': 'hanoch.schreiber@clalit.org.il', 'phone': '972-53-332-3248'}, {'name': 'Yair Daykan, MD', 'role': 'CONTACT', 'email': 'yair.daykan@clalit.org.il', 'phone': '0542198231'}, {'name': 'Hanoch Schreiber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hanoch Schreiber', 'role': 'CONTACT', 'email': 'Hanochsc@gmail.com', 'phone': '0533323248'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Hanoch Schreiber, MD', 'role': 'CONTACT', 'email': 'hanoch.schreiber@clalit.org.il', 'phone': '972-53-332-3248'}, {'name': 'Tal Weissbach, MD', 'role': 'CONTACT', 'email': 'ferbyt@gmail.com', 'phone': '972-546-250-299'}], 'overallOfficials': [{'name': 'Hanoch Schreiber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit Health Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All primary and secondary outcome measures will be made available within 6 months of syudy completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'hanoch schreiber', 'investigatorAffiliation': 'Meir Medical Center'}}}}