Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-07 @ 1:52 AM
Study NCT ID:
NCT03344302
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin Administration During Cesarean Section
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2017-11-13', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of blood loss', 'timeFrame': '4 hours', 'description': 'collection of the blood in the drape below the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravida or multigravida\n* Term (37 - 42 weeks),\n* Singleton pregnancies\n* Booked for elective caesarean section.\n* Accepting to participate in the study.\n\nExclusion Criteria:\n\n* • Medical disorders involving the heart, liver, kidney or brain.\n\n * Diabetes mellitus and hypertension.\n * Blood disorders (e.g. coagulopathies, thrombocytopenia)\n * Patients requiring blood transfusion due to anemia.\n * Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.\n * Previous 2 or more cesarean section\n * Placenta previa or placental abruption\n * Previous major obstetric haemorrhage (\\>1000 ml) in previous deliveries.\n * Known fibroid or adenomyosis.\n * Women who received anticoagulant therapy.\n * Severe preeclampsis.\n * Uterine anomalies.'}, 'identificationModule': {'nctId': 'NCT03344302', 'briefTitle': 'Oxytocin Administration During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': '100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride', 'armGroupLabels': ['Control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}