Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 5:40 AM
Study NCT ID:
NCT01308359
Status:
UNKNOWN
Last Update Posted:
2011-03-04
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Glucose and Saline for Fetal Movement Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fetal movements as perceived by the mother', 'timeFrame': 'one hour', 'description': 'Effect of glucose versus saline infusion on the perception of fetal movements. the mother will count fetal movements that she feels one hour following saline/glucose infusion and report to the obstetrician in charge. The research aims to clarify whether glucose increases fetal movements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fetal movement'], 'conditions': ['Fetal Movement Perception']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy parturients with singleton pregnancy during 3rd trimester\n\nExclusion Criteria:\n\n* Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios'}, 'identificationModule': {'nctId': 'NCT01308359', 'briefTitle': 'Use of Glucose and Saline for Fetal Movement Perception', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Impact of Glucose Administration on Perception of Fetal Movements', 'orgStudyIdInfo': {'id': 'TASMC-10-am-0512-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glucose 5%', 'description': 'glucose 5%', 'interventionNames': ['Drug: IV glucose 5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'saline', 'description': 'saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'IV glucose 5%', 'type': 'DRUG', 'description': '500 ml glucose 5% within 30 minutes', 'armGroupLabels': ['glucose 5%']}, {'name': 'saline', 'type': 'DRUG', 'description': 'saline', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ariel Many, MD', 'role': 'CONTACT', 'phone': '97236925633'}, {'name': 'Nadav Mishan, MD', 'role': 'CONTACT', 'phone': '97236925633'}, {'name': 'Ariel Many, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nadav Mishan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lis Maternity Hospital, Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Ariel Many, MD', 'role': 'CONTACT', 'email': 'many@post.tau.ac.il', 'phone': '97236925633'}, {'name': 'NAdav Mishan, MD', 'role': 'CONTACT', 'email': 'nadavmi@gmail.com', 'phone': '97236925633'}], 'overallOfficials': [{'name': 'Ariel Many, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lis Maternity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Ariel Many, MD', 'oldOrganization': 'Dep. of OB&GYN, Tel Aviv Sourasky Medical Center'}}}}