Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-01-04 @ 8:55 PM
Study NCT ID:
NCT02633995
Status:
UNKNOWN
Last Update Posted:
2015-12-17
First Post:
2015-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anaesthesia and Severe 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': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-12-06', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of hypotension is high during spinal anesthesia for Cesarean section and it may approach values up to 95 %.', 'detailedDescription': 'The parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (A) and a normotensive group (B). All will receive colload (500 ml voluven) as a coload via wide bore (16 Gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. Standard monitoring with electrocardiography, automated non-invasive arterial pressure (NIAP) measurement, and pulse oximetry will be performed. Systolic arterial pressure (SAP), mean arterial pressure (MAP) and diastolic arterial pressure (DAP) will be monitored. Baseline values will be recorded in the supine position. Central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes.\n\nSpinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'two equal groups (n=30), Pregnant females with severe pre-eclampsia : (group A) and normotensive parturients (group B) presenting for full term delivery with caesarean section using spinal anesthesia at Kasr Al Aini hospital in the duration of 3 months from december 2015 to march 2016 will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 - 40 years\n* Severely Pre-eclamptic females, severe pre-eclampsia is defined as hypertension( BP \\> 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(\\<500 ml in 24 hours) with at least one maternal organ dysfunction .\n\nExclusion Criteria:\n\n* Age : \\<18 years\n* Obese patients with BMI \\> 35 Kg/m2\n* Preterm delivery\n* Patients with contraindication to spinal anesthesia.\n* Patients in active labor'}, 'identificationModule': {'nctId': 'NCT02633995', 'briefTitle': 'Spinal Anaesthesia and Severe Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)', 'orgStudyIdInfo': {'id': 'Mina'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preeclampsia', 'description': 'spinal anaesthesia will be given for cesarean section', 'interventionNames': ['Procedure: spinal anaesthesia']}, {'label': 'normotensive', 'description': 'spinal anaesthesia will be given for cesarean section', 'interventionNames': ['Procedure: spinal anaesthesia']}], 'interventions': [{'name': 'spinal anaesthesia', 'type': 'PROCEDURE', 'description': 'regional anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.', 'armGroupLabels': ['normotensive', 'preeclampsia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed ib elsakka, m.d.', 'role': 'CONTACT', 'email': 'ahmedsakka2@hotmail.com', 'phone': '00201002424221'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ahmed ib elsakka, m.d.', 'role': 'CONTACT', 'email': 'ahmedsakka2@hotmail.com', 'phone': '00201002414221'}, {'name': 'mina ad helmy', 'role': 'CONTACT', 'email': 'dr_mina20002010@yahoo.com'}], 'overallOfficials': [{'name': 'maher fawzy, m.d.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'department of anaesthesia faculty of medicine cairo university'}, {'name': 'nisreen refaie, m.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'department of anaesthesia faculty of medicine cairo university'}, {'name': 'ahmed elsakka, m.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'department of anaesthesia faculty of medicine cairo university'}, {'name': 'mina helmy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of anaesthesia faculty of medicine cairo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia faculty of medicine cairo university', 'investigatorFullName': 'ahmed elsakka', 'investigatorAffiliation': 'Cairo University'}}}}