Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT02902068
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Monitoring in Women Throughout Cesarean Sections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2016-06-01', 'studyFirstSubmitQcDate': '2016-09-11', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic changes in cesarean section as measured by NICaS parameters.', 'timeFrame': 'A year', 'description': "This study's primary objective is to evaluate how anesthesia influences cardiac output during cesarean section deliveries"}], 'secondaryOutcomes': [{'measure': 'Hemodynamic changes measured by NICaS parameters and their correlation with pain in women undergoing cesarean sections as measured by VAS.', 'timeFrame': 'A year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemodynamics']}, 'referencesModule': {'references': [{'pmid': '24300387', 'type': 'BACKGROUND', 'citation': 'Dennis AT, Dyer RA. Cardiac output monitoring in obstetric anaesthesia. Int J Obstet Anesth. 2014 Feb;23(1):1-3. doi: 10.1016/j.ijoa.2013.11.001. Epub 2013 Nov 13. No abstract available.'}, {'pmid': '21920211', 'type': 'BACKGROUND', 'citation': 'Bliacheriene F, Carmona MJ, Barretti Cde F, Haddad CM, Mouchalwat ES, Bortolotto MR, Francisco RP, Zugaib M. Use of a minimally invasive uncalibrated cardiac output monitor in patients undergoing cesarean section under spinal anesthesia: report of four cases. Rev Bras Anestesiol. 2011 Sep-Oct;61(5):610-8, 334-8. doi: 10.1016/S0034-7094(11)70072-1. English, Portuguese, Spanish.'}, {'pmid': '18946283', 'type': 'BACKGROUND', 'citation': 'Dyer RA, James MF. Maternal hemodynamic monitoring in obstetric anesthesia. Anesthesiology. 2008 Nov;109(5):765-7. doi: 10.1097/ALN.0b013e31818a3825. No abstract available.'}, {'pmid': '18431110', 'type': 'BACKGROUND', 'citation': 'Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.'}, {'pmid': '25915203', 'type': 'BACKGROUND', 'citation': 'Langesaeter E, Gibbs M, Dyer RA. The role of cardiac output monitoring in obstetric anesthesia. Curr Opin Anaesthesiol. 2015 Jun;28(3):247-53. doi: 10.1097/ACO.0000000000000190.'}, {'pmid': '19741494', 'type': 'BACKGROUND', 'citation': 'Dyer RA, Reed AR, van Dyk D, Arcache MJ, Hodges O, Lombard CJ, Greenwood J, James MF. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009 Oct;111(4):753-65. doi: 10.1097/ALN.0b013e3181b437e0.'}, {'pmid': '18946298', 'type': 'BACKGROUND', 'citation': 'Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.'}, {'pmid': '22104076', 'type': 'BACKGROUND', 'citation': 'Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.'}, {'pmid': '21415724', 'type': 'BACKGROUND', 'citation': 'Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5.'}, {'pmid': '16709208', 'type': 'BACKGROUND', 'citation': 'Tihtonen K, Koobi T, Yli-Hankala A, Huhtala H, Uotila J. Maternal haemodynamics in pre-eclampsia compared with normal pregnancy during caesarean delivery. BJOG. 2006 Jun;113(6):657-63. doi: 10.1111/j.1471-0528.2006.00931.x.'}, {'pmid': '21098311', 'type': 'BACKGROUND', 'citation': 'Melchiorre K, Sutherland GR, Baltabaeva A, Liberati M, Thilaganathan B. Maternal cardiac dysfunction and remodeling in women with preeclampsia at term. Hypertension. 2011 Jan;57(1):85-93. doi: 10.1161/HYPERTENSIONAHA.110.162321. Epub 2010 Nov 22.'}, {'pmid': '19061708', 'type': 'BACKGROUND', 'citation': 'McDonald SD, Malinowski A, Zhou Q, Yusuf S, Devereaux PJ. Cardiovascular sequelae of preeclampsia/eclampsia: a systematic review and meta-analyses. Am Heart J. 2008 Nov;156(5):918-30. doi: 10.1016/j.ahj.2008.06.042. Epub 2008 Oct 2.'}, {'pmid': '18431115', 'type': 'BACKGROUND', 'citation': 'Dyer RA, Piercy JL, Reed AR, Lombard CJ, Schoeman LK, James MF. Hemodynamic changes associated with spinal anesthesia for cesarean delivery in severe preeclampsia. Anesthesiology. 2008 May;108(5):802-11. doi: 10.1097/01.anes.0000311153.84687.c7.'}, {'pmid': '20736431', 'type': 'BACKGROUND', 'citation': 'Critchley LA, Lee A, Ho AM. A critical review of the ability of continuous cardiac output monitors to measure trends in cardiac output. Anesth Analg. 2010 Nov;111(5):1180-92. doi: 10.1213/ANE.0b013e3181f08a5b. Epub 2010 Aug 24.'}, {'pmid': '12578081', 'type': 'BACKGROUND', 'citation': 'Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999 Feb;15(2):85-91. doi: 10.1023/a:1009982611386.'}, {'pmid': '19452431', 'type': 'BACKGROUND', 'citation': 'Chaffin DG, Webb DG. Outcomes of pregnancies at risk for hypertensive complications managed using impedance cardiography. Am J Perinatol. 2009 Nov;26(10):717-21. doi: 10.1055/s-0029-1223283. Epub 2009 May 18.'}]}, 'descriptionModule': {'briefSummary': "In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery.\n\nThis study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)", 'detailedDescription': "This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.\n\nTwo hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.\n\nFollowing obtaining an informed consent maternal cardiac output will be monitored.\n\nThe monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.\n\nMonitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).\n\nPreoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.\n\nRecorded data will include:\n\n* Demographic and obstetric - age, weight, height, current hemoglobin, co-morbidities, regular medication and other obstetric data.\n* Cardiovascular risk factors - a family history of cardiovascular disease, smoking, BMI\n* Obstetric history - obstetric background (history of gestational diabetes, preeclampsia, intrauterine growth restriction (IUGR), stillbirths or placental abruption).\n* Threshold of pain according to VAS It should be emphasized that the conduct of the study will not interfere in with cesarean delivery protocol in any way."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy and hypertensive women above 18 undergoing cesarean section deliveries.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.\n\nExclusion Criteria:\n\n\\- Women under age 18 , and women who don't understand the inform consent form will be excluded from participating."}, 'identificationModule': {'nctId': 'NCT02902068', 'briefTitle': 'Hemodynamic Monitoring in Women Throughout Cesarean Sections', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance', 'orgStudyIdInfo': {'id': '0512-15-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parturients undergoing cesarean section', 'description': 'Healthy parturients, hypertensive parturients and parturients suffering from preeclampsia above 18 undergoing cesarean section deliveries .', 'interventionNames': ['Device: NICaS Bio Impedance']}], 'interventions': [{'name': 'NICaS Bio Impedance', 'type': 'DEVICE', 'description': "Hemodynamic monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.\n\nMonitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the PACU.\n\nPreoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.", 'armGroupLabels': ['Parturients undergoing cesarean section']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petach Tikvah', 'country': 'Israel', 'facility': 'Beilinson hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'In this study the investigators would like to monitor cardiac output by the use of NICaS bioimpedance in women undergoing cesarean section delivery.\n\nThis study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}