Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 9:16 PM
Study NCT ID:
NCT04492150
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glucose 5% on Labor Length
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 476}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the duration of labor', 'timeFrame': '24 hours', 'description': 'the duration from the beginning of active labor (cervical exam between 3 and 5 cm with regular uterine contractions) to fetal delivery, reported in minutes.'}], 'secondaryOutcomes': [{'measure': 'Rate of cesarean sections', 'timeFrame': '24 hours', 'description': 'the number of cases delivered by cesarean section'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'Induction of labor, is one of the most common obstetric procedures done routinely in modern obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an induction of labor. However, accurate data about percentage of women undergoing induction of labor in Egypt is not accurately known.\n\nOne of the recent research era in current obstetrics is the optimal intravenous (IV) hydration of the pregnant women in labor.Current evidences available in our hands, suggest that maternal hydration appears to fasten labor progress and enhance the action of oxytocin, if the later is used for augmentation. However, the addition of glucose supplementation to this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is controversial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years) multiparous women\n* Late Term Pregnancy ( gestational Age Between 40-42 weeks)\n* Uncomplicated singleton pregnancy with cephalic presentation.\n* Favorable cervix for induction (Bishop score\\<6) without ruptured membranes.\n\nExclusion Criteria:\n\n* Women with chronic diseases or complicated pregnancy; gestational and pre gestational ( type 1 \\& 2)diabetes, preeclampsia and\\\\or renal and\\\\or maternal heart diseases.\n* Non-cephalic presentations, multiple pregnancies, or cervix unfavorable for induction.\n* Other indications for cesarean delivery'}, 'identificationModule': {'nctId': 'NCT04492150', 'briefTitle': 'Effect of Glucose 5% on Labor Length', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'The Effect of Adding Parenteral Dextrose Solution During Induction of Labor on Total Labor Length Among Multiparous Women in Ismailia, Egypt: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '4018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.', 'interventionNames': ['Drug: Dextrose 5%/Nacl 0.3% Inj_#3', 'Drug: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'women who will receive 250 mL/hour of normal saline for the whole duration of induction', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dextrose 5%/Nacl 0.3% Inj_#3', 'type': 'DRUG', 'description': '250 mL/hour of dextrose 5% intravenous drip', 'armGroupLabels': ['study group']}, {'name': 'Saline', 'type': 'DRUG', 'description': '250 mL/hour of normal saline intravenous drip', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Salwa Hussein, MMBCh', 'role': 'CONTACT'}], 'facility': 'Suez canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'centralContacts': [{'name': 'Salwa H Tammam, M. B. B. Ch', 'role': 'CONTACT', 'email': 'Dr.salwa.hussein.tammam@gmail.com', 'phone': '00201012869258'}], 'overallOfficials': [{'name': 'Zakia M Ibraheim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Gynecology and Obstetrics'}, {'name': 'Mariam L Mohammed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Gynecology and Obstetrics'}, {'name': 'Hanan M Ghoneim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Gynecology and Obstetrics'}, {'name': 'Ahmed M Abbas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Gynecology and Obstetrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Salwa Hussein Ismaeil Tammam', 'investigatorAffiliation': 'Suez Canal University'}}}}