Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-05 @ 2:22 AM
Study NCT ID:
NCT04406051
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2020-05-24', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypotension', 'timeFrame': 'intraoperative', 'description': 'any occurence of hypotension (systolic blood pressure\\<80% of baseline) throughout the operation will be recorded'}], 'secondaryOutcomes': [{'measure': 'need for vasoconstrictor', 'timeFrame': 'intraoperative', 'description': 'any need for vasoconstrictor during the operation will be recorded'}, {'measure': 'type of vasoconstrictor administered', 'timeFrame': 'intraoperative', 'description': 'phenylephrine versus ephedrine'}, {'measure': 'total dose of vasoconstrictor administered', 'timeFrame': 'intraoperative', 'description': 'total dose in mg for ephedrine or μg for phenylephrine administered'}, {'measure': 'incidence of hypertension', 'timeFrame': 'intraoperative', 'description': 'any incidence of systolic blood pressure\\>120% of baseline will be recorded'}, {'measure': 'incidence of bradycardia', 'timeFrame': 'intraoperative', 'description': 'any incidence of maternal bradycardia (heart rate\\<60/min) will be recorded'}, {'measure': 'need for atropine', 'timeFrame': 'intraoperative', 'description': 'any need for atropine during the operation because of bradycardia will be recorded'}, {'measure': 'modification or cessation of the infusion', 'timeFrame': 'intraoperative', 'description': 'any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded'}, {'measure': 'incidence of nausea/vomiting', 'timeFrame': 'intraoperative', 'description': 'any occurence of nausea and/or vomiting during the operation will be recorded'}, {'measure': 'Neonatal Apgar score at 1 min', 'timeFrame': '1 min post delivery', 'description': 'Neonatal Apgar score will be recorded at 1 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.'}, {'measure': 'Neonatal Apgar score at 5 min', 'timeFrame': '5 min post delivery', 'description': 'Neonatal Apgar score will be recorded at 5 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.'}, {'measure': 'neonatal blood gases', 'timeFrame': '1 min post delivery', 'description': 'fetal cord blood analysis will be performed immediately post-delivery'}, {'measure': 'glucose in neonatal blood', 'timeFrame': '1 min post delivery', 'description': 'glucose will be measured in the cord blood gas sample taken immediately post-delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension', 'Obstetric Anesthesia Problems', 'Cesarean Section Complications', 'Hypotensive', 'Vasoconstriction']}, 'referencesModule': {'references': [{'pmid': '23076903', 'type': 'BACKGROUND', 'citation': 'Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.'}, {'pmid': '20455872', 'type': 'BACKGROUND', 'citation': 'Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.'}, {'pmid': '20173633', 'type': 'BACKGROUND', 'citation': 'Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.'}, {'pmid': '29090733', 'type': 'BACKGROUND', 'citation': 'Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.'}, {'pmid': '19859776', 'type': 'BACKGROUND', 'citation': 'Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.'}, {'pmid': '21948275', 'type': 'BACKGROUND', 'citation': 'Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.'}, {'pmid': '23379937', 'type': 'BACKGROUND', 'citation': 'Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section', 'detailedDescription': 'Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.\n\nThe aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult parturients, American Society of Anesthesiologists (ASA) I-II,\n* singleton gestation\\>37 weeks\n* elective cesarean section\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\>40 kg/m2\n* Body weight \\<50 kg\n* Body weight\\>100 kg\n* height\\<150 cm\n* height\\>180 cm\n* multiple gestation\n* fetal abnormality\n* fetal distress\n* active labor\n* cardiac disease\n* pregnancy-induced hypertension\n* thrombocytopenia\n* coagulation abnormalities\n* use of antihypertensive medication during pregnancy\n* communication or language barriers\n* lack of informed consent\n* contraindication for regional anesthesia'}, 'identificationModule': {'nctId': 'NCT04406051', 'acronym': 'annie-manos', 'briefTitle': 'Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?', 'orgStudyIdInfo': {'id': 'nor-cryst vs. nor-coll'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'norepinephrine infusion and colloid preloading (NOR-COL)', 'description': 'in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)', 'interventionNames': ['Procedure: norepinephrine infusion and colloid preloading (NOR-COL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'norepinephrine infusion and crystalloid co-loading (NOR-CRYS)', 'description': 'in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)', 'interventionNames': ['Procedure: norepinephrine infusion and crystalloid co-loading (NOR-CRYST)']}], 'interventions': [{'name': 'norepinephrine infusion and colloid preloading (NOR-COL)', 'type': 'PROCEDURE', 'description': 'in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia', 'armGroupLabels': ['norepinephrine infusion and colloid preloading (NOR-COL)']}, {'name': 'norepinephrine infusion and crystalloid co-loading (NOR-CRYST)', 'type': 'PROCEDURE', 'description': 'in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia', 'armGroupLabels': ['norepinephrine infusion and crystalloid co-loading (NOR-CRYS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115 28', 'city': 'Athens', 'country': 'Greece', 'facility': 'Aretaieion University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Alexandra General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital'}, {'name': 'Emmanouil Stamatakis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandra General Hospital of Athens'}, {'name': 'Sofia Hadzilia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandra General Hospital of Athens'}, {'name': 'Dimitrios Valsamidis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandra General Hospital of Athens'}, {'name': 'Konstantina Kalopita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandra General Hospital of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandra Hospital, Athens, Greece', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}