Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 2:26 AM
Study NCT ID:
NCT04367103
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine for Hypotension in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-30', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fetal outcome', 'timeFrame': 'at 1, 5 and 8 minutes', 'description': 'APGAR score'}, {'measure': 'mixed blood gas', 'timeFrame': '1 minute after delivery', 'description': 'Umbilical artery and vein blood gas'}, {'measure': 'Admission to neonatal ICU (NICU)', 'timeFrame': 'first 24 hours after delivery', 'description': 'the need for NICU admission'}], 'primaryOutcomes': [{'measure': 'Incidence of hypotensive episodes.', 'timeFrame': '15-20 minutes', 'description': 'Hypotension is defined as \\<80% of baseline or systolic blood pressure (SBP) \\<100 mmHg.'}], 'secondaryOutcomes': [{'measure': 'Incidence of maternal bradycardia.', 'timeFrame': '15-20 minutes', 'description': 'Bradycardia is defined as heart rate (HR) \\< 50 beats/min'}, {'measure': 'Incidence of reactive hypertension', 'timeFrame': '20 minutes', 'description': 'defined as \\>120% of baseline.'}, {'measure': 'nausea and vomiting', 'timeFrame': '20 minutes', 'description': 'Incidence of nausea and vomiting attacks.'}, {'measure': 'Total dose of vasopressor', 'timeFrame': '20 minutes', 'description': 'Total dose of vasopressor used.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post spinal anesthesia'], 'conditions': ['Hypotension', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.', 'detailedDescription': 'Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.\n\nExclusion Criteria:\n\n* Patient refusal either to study enrollment or to spinal anesthesia.\n\n * Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection.\n * Allergy to any of study drugs.\n * Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding\n * BMI \\> 40 kg/m²\n * Baseline systolic blood pressure \\< 100 mmHg.'}, 'identificationModule': {'nctId': 'NCT04367103', 'briefTitle': 'Norepinephrine for Hypotension in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section', 'orgStudyIdInfo': {'id': 'ShA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NEP group', 'description': 'Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PHE group', 'description': 'Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.', 'interventionNames': ['Drug: Phenylephrine']}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['noradrenaline'], 'description': 'prophylaxis for hypotension', 'armGroupLabels': ['NEP group']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['phenylephrine hydrochloride'], 'description': 'standerd prophylaxis for hypotension', 'armGroupLabels': ['PHE group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed M. Abdellatif, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Shimaa A. Husien, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shimaa Abbas Hassan', 'investigatorAffiliation': 'Assiut University'}}}}