Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-04 @ 4:10 AM
Study NCT ID:
NCT02786992
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2016-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol+Oxytocin vs. Carbetocin in CS
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': 'D016595', 'term': 'Misoprostol'}, {'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'C020731', 'term': 'carbetocin'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-05-31', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of post-partum hemorrhage', 'timeFrame': '24 hours'}, {'measure': 'amount of blood loss', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)', 'timeFrame': '24 hours', 'description': 'An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.'}, {'measure': 'Number of participants needing hemostatic surgical interventions', 'timeFrame': 'intra-operative'}, {'measure': 'Hemoglobin deficit in gm/dl', 'timeFrame': '24 hours', 'description': 'difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl'}, {'measure': 'APGAR score at 1 minute and 5 minutes', 'timeFrame': '1 minute and 5 minutes'}, {'measure': 'Number of participants with NICU admission', 'timeFrame': '24 hours'}, {'measure': 'Drug side effects', 'timeFrame': '24 hours'}, {'measure': 'Time till resuming bowel habits', 'timeFrame': '24 hours', 'description': 'Time of passing gas will be recorded how many hours post-operative'}, {'measure': 'hematocrit deficit in %', 'timeFrame': '24 hours', 'description': 'difference between pre-operative and 24 hours post-operative hematocrit in %'}]}, 'conditionsModule': {'keywords': ['Misoprostol', 'Oxytocin', 'Carbetocin', 'Prevention', 'Post-partum hemorrhage'], 'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).\n\nExclusion Criteria:\n\n* hypersensitivity to oxytocin, carbetocin or prostaglandins\n* contraindication to prostaglandins (e.g. glaucoma)\n* history of significant heart disease\n* severe asthma\n* epilepsy\n* history or evidence of liver\n* renal or vascular disease\n* history of coagulopathy\n* thrombocytopenia or anticoagulant therapy\n* women with HELLP syndrome\n* eclampsia\n* women presenting by placental abruption\n* contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.'}, 'identificationModule': {'nctId': 'NCT02786992', 'acronym': 'CS', 'briefTitle': 'Misoprostol+Oxytocin vs. Carbetocin in CS', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section', 'orgStudyIdInfo': {'id': 'AS1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol + Oxytocin', 'description': '400 ug sublingual misoprostol + 10 IU Oxytocin IVI', 'interventionNames': ['Drug: Misoprostol', 'Drug: Oxytocin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbetocin', 'description': '100 ug Carbetocin IV', 'interventionNames': ['Drug: Carbetocin', 'Drug: Placebo']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Mesotec', 'Mesotac'], 'armGroupLabels': ['Misoprostol + Oxytocin']}, {'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon'], 'armGroupLabels': ['Misoprostol + Oxytocin']}, {'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Pabal'], 'armGroupLabels': ['Carbetocin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Carbetocin', 'Misoprostol + Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed S Sweed, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}