Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT00991627
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2009-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Approaches to Maternal Hypotension During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D004809', 'term': 'Ephedrine'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal arterial base excess', 'timeFrame': '<5 min from birth'}], 'secondaryOutcomes': [{'measure': 'Neonatal arterial and venous pH, venous base excess', 'timeFrame': '<5 min from birth'}, {'measure': 'Apgar score', 'timeFrame': '1 and 5 minutes from birth'}, {'measure': 'Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)', 'timeFrame': 'Baseline and up to 12 h postoperatively'}, {'measure': 'Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).', 'timeFrame': 'q5min from anesthesia to end of surgery'}, {'measure': 'Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)', 'timeFrame': 'q5min from anesthesia to end of surgery'}, {'measure': 'Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.', 'timeFrame': 'q5min from anesthesia to end of surgery'}, {'measure': 'Administered atropine', 'timeFrame': 'from anesthesia to end of surgery'}, {'measure': 'Amount of ephedrine administered (mg)', 'timeFrame': 'from anesthesia to end of surgery'}, {'measure': 'Time between induction of anesthesia and skin incision'}, {'measure': 'Time between skin incision and delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ephedrine', 'Adrenergic Agents', 'Central Nervous System Stimulants', 'Sympathomimetics', 'Vasoconstrictor Agents', 'Bupivacaine', 'Anesthetics, Local', 'Atropine', 'Adjuvants, Anesthesia', 'Anti-Arrhythmia Agents', 'Bronchodilator Agents', 'Muscarinic Antagonists', 'Mydriatics', 'Parasympatholytics', 'Morphine', 'Analgesics, Opioid', 'Narcotics', "Ringer's Lactate", 'Isotonic Solutions', 'Hypotension', 'Blood pressure', 'Signs and Symptoms', 'Pregnancy', 'Anesthesia, Obstetrical', 'Inferior Vena Cava'], 'conditions': ['Pregnancy', 'Cesarean Section', 'Anesthesia,Spinal', 'Hypotension']}, 'referencesModule': {'references': [{'pmid': '8164943', 'type': 'BACKGROUND', 'citation': 'Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.'}, {'pmid': '17054153', 'type': 'BACKGROUND', 'citation': 'Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.'}, {'pmid': '15321375', 'type': 'BACKGROUND', 'citation': 'Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.'}, {'pmid': '8678144', 'type': 'BACKGROUND', 'citation': 'Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4. doi: 10.1016/s0002-9378(96)70214-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.', 'detailedDescription': 'The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy.\n\nDifferent strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones.\n\nAccording to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation.\n\nNon-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava.\n\nThe aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing spinal anesthesia for elective Cesarean section\n* Patients in ASA Physical Status Class I or II\n* Informed written consent to participation\n* Positive Supine Stress Test\n\nExclusion Criteria:\n\n* Any known fetal pathology\n* Indication to general anesthesia\n* Known allergy to any of the study drugs'}, 'identificationModule': {'nctId': 'NCT00991627', 'briefTitle': 'Different Approaches to Maternal Hypotension During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'ANEST-OST-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacological', 'description': 'Patients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Morphine', "Drug: Lactated Ringer's solution", 'Drug: Ephedrine, continuous infusion', 'Drug: Ephedrine, bolus', 'Drug: Atropine']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Pharmacological', 'description': 'Patients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Morphine', "Drug: Lactated Ringer's solution", 'Drug: Ephedrine, bolus', 'Drug: Atropine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcain', 'Local Anesthetic'], 'description': '10 mg of a 5 mg/ml hyperbaric solution, intrathecally', 'armGroupLabels': ['Non-Pharmacological', 'Pharmacological']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['Intrathecal morphine'], 'description': '200 µg of a 100 µg/ml solution, intrathecally', 'armGroupLabels': ['Non-Pharmacological', 'Pharmacological']}, {'name': "Lactated Ringer's solution", 'type': 'DRUG', 'description': '25 ml/min intravenously', 'armGroupLabels': ['Non-Pharmacological', 'Pharmacological']}, {'name': 'Ephedrine, continuous infusion', 'type': 'DRUG', 'description': '37.5 mg/h intravenously', 'armGroupLabels': ['Pharmacological']}, {'name': 'Ephedrine, bolus', 'type': 'DRUG', 'description': '6.25 mg IV bolus prn.\n\nHypotension defined according to study protocol for each arm.', 'armGroupLabels': ['Non-Pharmacological', 'Pharmacological']}, {'name': 'Atropine', 'type': 'DRUG', 'description': '0.1 mg/kg iv bolus prn\n\nBradycardia defined as 50% drop in heart rate from baseline values.', 'armGroupLabels': ['Non-Pharmacological', 'Pharmacological']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'state': 'PR', 'country': 'Italy', 'facility': 'University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Guido Fanelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy'}, {'name': 'Andrea Cornini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma'}, {'name': 'Michele Zasa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Guido Fanelli', 'oldOrganization': 'UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma'}}}}