Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-03 @ 7:35 AM
Study NCT ID:
NCT02080104
Status:
UNKNOWN
Last Update Posted:
2014-03-06
First Post:
2014-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2014-03-01', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early postpartum hemorrhage', 'timeFrame': 'postpartum 24 hours', 'description': 'Blood loss during the birth and postpartum hemorrhage asset (within 24 hours\\> 500 cc blood loss)'}], 'secondaryOutcomes': [{'measure': 'Blood transfusion requirement', 'timeFrame': 'postpartum 24 hours', 'description': '* Blood transfusion requirement\n* duration of phase 3 (\\> 30 min)\n* necessity of additional treatments for postpartum hemorrhage\n* the necessity of manual removal of placenta\n* side effects of the'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postpartum hemorrhage', 'oxytocin', 'vaginal delivery', 'prophylactic'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '33169839', 'type': 'DERIVED', 'citation': 'Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial', 'detailedDescription': 'Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. In this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.In some countries, intravenous access can not be provided easily . Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . For this reason, less educated , which can be applied by those offering health services .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Research volunteers, the undersigned, pregnant women\n2. Only with vaginal delivery (episiotomy and perineal tears can)\n3. \\> 34 weeks or more will be\n4. Cephalic presentation will be\n5. At low risk of postpartum hemorrhage\n\nExclusion Criteria:\n\n1. \\<18 years\n2. Multiple pregnancies\n3. The presence of uterine myoma\n4. Having postpartum hemorrhage in previous pregnancies\n5. Placenta previa, polyhydramnios\n6. More than four parity\n7. Fetal macrosomia\n8. Hb \\<9mg/dl\n9. preeclampsia\n10. Uterine anomalies\n11. Receiving anticoagulant therapy, suspected coagulopathy\n12. \\> 42 weeks of pregnancy\n13. Oxytocin allergy -'}, 'identificationModule': {'nctId': 'NCT02080104', 'acronym': 'oxytocin', 'briefTitle': 'Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '27-01.14-02-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous 10 ıu oxytocin', 'description': 'group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery', 'interventionNames': ['Drug: intarvenous and intramusculer 10 IU oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'intramusculer 10 ıu oxytocin', 'description': 'group which oxytocin administered intramusculary after vaginal delivery', 'interventionNames': ['Drug: intarvenous and intramusculer 10 IU oxytocin']}], 'interventions': [{'name': 'intarvenous and intramusculer 10 IU oxytocin', 'type': 'DRUG', 'description': 'intarvenous and intramusculer 10 IU oxytocin', 'armGroupLabels': ['intramusculer 10 ıu oxytocin', 'intravenous 10 ıu oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34140', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'hediye dağdeviren, md', 'role': 'CONTACT', 'email': 'hediyedagdeviren@gmail.com', 'phone': '2124147171', 'phoneExt': '7372'}, {'name': 'hüseyin cengiz, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bakırkoy Dr Sadi Konuk Teaching and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'nurten kayacan aydemir', 'role': 'CONTACT', 'email': 'nurten.aydemir@beah.gov.tr', 'phone': '2124147171', 'phoneExt': '7372'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hediye Dagdeviren', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'md', 'investigatorFullName': 'Hediye Dagdeviren', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}