Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 9:22 PM
Study NCT ID:
NCT04556357
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}, {'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall stability of heart rate control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Evaluated by performance error (PE)'}, {'measure': 'The incidence of postspinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 80% of the baseline'}, {'measure': 'The incidence of severe post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 60% of the baseline'}, {'measure': 'The incidence of nausea and vomiting.', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Presence of nausea and vomiting in patients after spinal anesthesia'}, {'measure': 'The incidence of hypertension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\>120% of the baseline.'}, {'measure': 'pH', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases.'}, {'measure': 'Partial pressure of oxygen', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases.'}, {'measure': 'Base excess', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases.'}, {'measure': 'APGAR score', 'timeFrame': '1 min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}, {'measure': 'APGAR score', 'timeFrame': '5 min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}], 'primaryOutcomes': [{'measure': 'The incidence of bradycardia', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Heart rate \\< 60 beats/min'}], 'secondaryOutcomes': [{'measure': 'Overall stability of systolic blood pressure control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Evaluated by performance error (PE)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Norepinephrine', 'Postspinal anesthesia hypotension', 'Preeclampsia', 'Cesarean section'], 'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.', 'detailedDescription': 'Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria: Inclusion Criteria:\n\n* 18-45 years\n* Primipara or multipara\n* Singleton pregnancy ≥32 weeks\n* American Society of Anesthesiologists physical status classification II to III\n* Scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Baseline blood pressure ≥180 mmHg\n* Body height \\< 150 cm\n* Body weight \\> 100 kg or body mass index (BMI) ≥ 40 kg/m2\n* Eclampsia or chronic hypertension\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT04556357', 'briefTitle': 'Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'Yi Chen-2020-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Phenylephrine infusion simultaneous with subarachnoid block', 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Norepinephrine group', 'description': 'Norepinephrine infusion simultaneous with subarachnoid block', 'interventionNames': ['Drug: Norepinephrine']}], 'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['Vasopressors'], 'description': 'A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block', 'armGroupLabels': ['Control group']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Vasopressors'], 'description': 'A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block', 'armGroupLabels': ['Norepinephrine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}], 'overallOfficials': [{'name': 'Xinli Ni, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}