Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-08 @ 11:44 PM
Study NCT ID:
NCT02524002
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2014-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced vs. Routine Clear Liquid Intake in Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004420', 'term': 'Dystocia'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2014-08-15', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from admission to delivery', 'timeFrame': 'Participants will be followed during labor until delivery, an expected range of 1-48 hours', 'description': 'Up to 3 days from time of admission'}], 'secondaryOutcomes': [{'measure': 'Duration of second stage of labor', 'timeFrame': 'Participants will be followed during labor until delivery, an expected range of 1-48 hours', 'description': 'Time of complete cervical dilation to delivery of infant'}, {'measure': 'delivery in <24 hours', 'timeFrame': 'Participants will be followed during labor until delivery, an expected range of 1-48 hours'}, {'measure': 'cesarean delivery', 'timeFrame': 'Participants will be followed during labor until delivery, an expected range of 1-48 hours'}, {'measure': 'rate of composite adverse GI outcome (vomiting or diarrhea)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Any vomiting or diarrhea'}, {'measure': 'patient satisfaction with diet', 'timeFrame': 'Participants will be followed during labor until delivery, an expected range of 1-48 hours'}, {'measure': 'Urine Ketones', 'timeFrame': 'Participants will be followed during labor until full dilation, an expected range of 1-48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abnormal Labor', 'Prolonged Induction', 'Ketosis', 'Diet'], 'conditions': ['Abnormal Labor', 'Failed Induction of Labor', 'Ketosis']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.', 'detailedDescription': 'Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Nulliparity (first baby)\n* Admission with the intent to deliver vaginally\n* Gestational age \\>36 weeks\n* Age ≥ 18\n\nExclusion criteria:\n\n* Planned cesarean delivery\n* Renal Disease\n* Preeclampsia\n* Diabetes (Pre-gestational or Gestational)\n* Allergy to any component of sports drink\n* NPO diet by physician'}, 'identificationModule': {'nctId': 'NCT02524002', 'briefTitle': 'Enhanced vs. Routine Clear Liquid Intake in Labor', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance', 'orgStudyIdInfo': {'id': '22375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Clear Diet', 'description': 'This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.', 'interventionNames': ['Dietary Supplement: Usual clear diet']}, {'type': 'EXPERIMENTAL', 'label': 'Accel Gel', 'description': 'This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used).\n\nhttp://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html', 'interventionNames': ['Dietary Supplement: Accel Gel']}], 'interventions': [{'name': 'Accel Gel', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Accel Gel by PacificHealth Labs in Matawan, NJ.', 'armGroupLabels': ['Accel Gel']}, {'name': 'Usual clear diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Usual clear liquids', 'armGroupLabels': ['Usual Clear Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Laura Goetzl, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}