Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-24 @ 1:07 PM
Study NCT ID:
NCT04756661
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2021-02-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterotonics for Severe Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C020731', 'term': 'carbetocin'}, {'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D016595', 'term': 'Misoprostol'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of postpartum hemorrhage more than 1000 ml', 'timeFrame': '30 minutes', 'description': 'the amount of bleeding during and after CS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia Severe']}, 'descriptionModule': {'briefSummary': 'The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women which diagnosed with severe pre-eclampsia.\n* Singleton pregnancy.\n* Termination of pregnancy by Cesarean section after 28 weeks of gestation.\n\nExclusion Criteria:\n\n* Suspected or proven placental abruption.\n* Known placenta Previa or acreata.\n* Multiple pregnancies.\n* Obesity (BMI \\>35).\n* Anemia (\\<9 g/dl).\n* Retained placental tissues.\n* Big baby (\\> 4 kg).\n* Presence of coagulopathy.\n* Polyhydramnios.\n* Presence of Uterine fibroids.\n* Medical diseases as; cardiac, liver, renal or endocrine diseases.\n* General anesthesia.'}, 'identificationModule': {'nctId': 'NCT04756661', 'briefTitle': 'Uterotonics for Severe Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia', 'orgStudyIdInfo': {'id': 'CARBOXMISO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbetocin', 'description': 'Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.', 'interventionNames': ['Drug: Carbetocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin plus misoprostol', 'description': 'Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.', 'interventionNames': ['Drug: Oxytocin', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Carbetocin', 'type': 'DRUG', 'description': '100 mcg of Carbetocin intravenous injection', 'armGroupLabels': ['Carbetocin']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': '10 IU oxytocin IV drip', 'armGroupLabels': ['Oxytocin plus misoprostol']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': '400 mcg rectal', 'armGroupLabels': ['Oxytocin plus misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}