Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 12:34 PM
Study NCT ID:
NCT01242293
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2010-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapartum Hydration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-20', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of time from enrollment until delivery', 'timeFrame': 'within the first 48 hours after delivery'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'within the first 48 hours after delivery'}, {'measure': 'Neonatal outcome', 'timeFrame': 'within the first 48 hours after delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Labor Stage, First', 'Labor Stage, Second']}, 'referencesModule': {'references': [{'pmid': '28470550', 'type': 'DERIVED', 'citation': 'Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.', 'detailedDescription': 'During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women\n* Gestational age 37-41 weeks\n* Cervical dilatation 1-3 cm\n* Vertex presentation\n* Singleton\n\nExclusion Criteria:\n\n* Diabetes\n* Preeclampsia\n* Intra uterine fetal growth restriction\n* Duration of labor less than an hour\n* Maternal chronic disease\n* Maternal fever upon admission.'}, 'identificationModule': {'nctId': 'NCT01242293', 'briefTitle': 'Intrapartum Hydration', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'orgStudyIdInfo': {'id': '0062-10-EMC'}, 'secondaryIdInfos': [{'id': 'IH-1', 'type': 'OTHER', 'domain': '0062-10-EMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.9% Saline with glucose 5%', 'description': 'rate of infusion is 125cc/h', 'interventionNames': ['Other: 0.9% Saline with glucose 5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer lactate', 'description': 'rate of infusion is 250cc/h', 'interventionNames': ['Other: Ringer lactate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer lactate - Controls', 'description': 'rate of infusion is 125cc/h', 'interventionNames': ['Other: Ringer lactate - Controls']}], 'interventions': [{'name': '0.9% Saline with glucose 5%', 'type': 'OTHER', 'description': 'intravenous hydration at a rate of 125 ml per hour during labor', 'armGroupLabels': ['0.9% Saline with glucose 5%']}, {'name': 'Ringer lactate', 'type': 'OTHER', 'description': 'intravenous hydration at a rate of 250 ml per hour during labor', 'armGroupLabels': ['Ringer lactate']}, {'name': 'Ringer lactate - Controls', 'type': 'OTHER', 'description': 'intravenous hydration at a rate of 125 ml per hour during labor', 'armGroupLabels': ['Ringer lactate - Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Dep OB/GYN, HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Raed Salim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. OB/GYN, HaEmek Medical Center, Afula, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Raed Salim', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}