Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT03953066
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2019-04-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colostral Milk and Blood IL-6 Levels in Types of Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The serum IL-6 level', 'timeFrame': '8 weeks', 'description': 'the measurement of serum IL-6 level in blood'}, {'measure': 'Colostral Milk melatonin levels in different types of deliveries', 'timeFrame': '8 weeks', 'description': 'Colostral milk taken from the postpartum midnight breast milk were evaluated for melatonin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin,colostral milk,IL-6, delivery, cesarean section'], 'conditions': ['Indications for Care in Pregnancy; Labor; and Delivery']}, 'descriptionModule': {'briefSummary': 'The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section', 'detailedDescription': 'In this prospective randomized study, the investigators aimed to show the changes in the melatonin levels in colostral milk in spontaneous vaginal delivery,emergency cesarean and elective cesarean section patients and changes in blood IL-6 level before and after the delivery in same patient groups.\n\nthe investigators randomized 30 cases for each group for comparisons.Time range seems short in this study but participating hospital setting is a busy maternity hospital thus it will be performed easily.\n\nThe purpose of this study is to demonstrate the beneficial effect of spontaneous vaginal delivery on the secretion of melatonin which is solely secreted by the mother and the newborn is dependent on maternal milk oriented melatonin until 12 th week after delivery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Pregnant women reached term\n* Patients with spontaneous vaginal delivery\n* Patients preferred cesarean section electively\n* Patient who had emergency cesarean section without additional medical or surgical problems\n\nExclusion Criteria\n\n* Women who had history of intrauterine fetal loss\n* Hypertention during pregnancy\n* Anemia\n* Thyroid diseases\n* Patients with chronic diseases\n* Smokers\n* Drug users'}, 'identificationModule': {'nctId': 'NCT03953066', 'briefTitle': 'Colostral Milk and Blood IL-6 Levels in Types of Labour', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Education and Research Hospital'}, 'officialTitle': 'The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section', 'orgStudyIdInfo': {'id': 'SamsunERH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'women with vaginal delivery', 'description': '30 women with spontaneous vaginal delivery will be included in group 1 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured', 'interventionNames': ['Other: The calculation of blood IL-6 and coloctral milk melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women with emergency cesarean section', 'description': '30 women with emergency cesarean section will be included in group 2 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured', 'interventionNames': ['Other: The calculation of blood IL-6 and coloctral milk melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women with elective cesarean section', 'description': '30 women with elective cesarean section will be included in group 3serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured', 'interventionNames': ['Other: The calculation of blood IL-6 and coloctral milk melatonin']}], 'interventions': [{'name': 'The calculation of blood IL-6 and coloctral milk melatonin', 'type': 'OTHER', 'otherNames': ['No other intervention'], 'description': 'Collected maternal colostral milk will be sampled for melatonin levels.Blood samples driven before and after delivery will be evaluated for IL-6 levels in each group', 'armGroupLabels': ['women with elective cesarean section', 'women with emergency cesarean section', 'women with vaginal delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55080', 'city': 'Samsun', 'state': 'Outside of the US', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun EAH', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Canan Soyer-Caliskan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun EAH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'canan soyer çalışkan', 'investigatorAffiliation': 'Samsun Education and Research Hospital'}}}}