Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-04-19 @ 4:54 PM
Study NCT ID:
NCT02376192
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2014-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Microcirculation & SDF Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Vessel Density (TVD)', 'timeFrame': 'Immediately prior to, and within 10 minutes of induction of spinal anesthesia'}, {'measure': 'Perfused Vessel Density (PVD)', 'timeFrame': 'Immediately prior to, and within 10 minutes of induction of spinal anesthesia'}, {'measure': 'Proportion of perfused vessels (PPV)', 'timeFrame': 'Immediately prior to, and within 10 minutes of induction of spinal anesthesia'}], 'primaryOutcomes': [{'measure': 'Microvascular Flow Index (MFI)', 'timeFrame': 'Immediately prior to, and within 10 minutes of induction of spinal anesthesia', 'description': 'The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia'}], 'secondaryOutcomes': [{'measure': 'Microvascular Flow Index (MFI)', 'timeFrame': 'Immediately prior to, and within 10 minutes of induction of spinal anesthesia', 'description': 'The difference between the MFI measured within 10 minutes following the induction of spinal anesthesia in participants who receive phenylephrine via a continuous infusion for the prevention of spinal anesthesia-induced hypotension compared to those who may receive phenylephrine boluses for treatment of spinal anesthesia-induced hypotension.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Microcirculation', 'Sidestream Dark Field (SDF) Imaging', 'Spinal Anesthesia', 'Phenylephrine'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '24934438', 'type': 'BACKGROUND', 'citation': 'George RB, DesRoches J, Abdo I, Lehmann C. Maternal microcirculation and sidestream dark field imaging: a prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women. Clin Hemorheol Microcirc. 2015;60(4):389-95. doi: 10.3233/CH-141851.'}, {'pmid': '24702490', 'type': 'BACKGROUND', 'citation': 'Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. doi: 10.33549/physiolres.932511. Epub 2014 Apr 3.'}, {'pmid': '24342223', 'type': 'BACKGROUND', 'citation': 'George RB, Munro A, Abdo I, McKeen DM, Lehmann C. An observational assessment of the sublingual microcirculation of pregnant and non-pregnant women. Int J Obstet Anesth. 2014 Feb;23(1):23-8. doi: 10.1016/j.ijoa.2013.08.013. Epub 2013 Sep 8.'}, {'pmid': '24448730', 'type': 'BACKGROUND', 'citation': 'Lehmann Ch, Abdo I, Kern H, Maddison L, Pavlovic D, Sharawi N, Starkopf J, Hall R, Johnson P, Williams L, Cerny V; MiDAS (Microcirculation Diagnostics and Applied Studies) group. Clinical evaluation of the intestinal microcirculation using sidestream dark field imaging--recommendations of a round table meeting. Clin Hemorheol Microcirc. 2014;57(2):137-46. doi: 10.3233/CH-141810.'}]}, 'descriptionModule': {'briefSummary': "This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)\n* Singleton pregnancies\n* 36-42 weeks gestation\n* Non-labouring\n* Scheduled cesarean delivery\n* English speaking\n* Age 18-45 years\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Hypertensive disease of pregnancy (i.e. mild \\& severe preeclampsia)\n* Allergy to phenylephrine, or any other standardized medication\n* Obesity (BMI \\> 35 kg/m2)\n* Diabetes Mellitus type 1\n* Smoker\n* Coffee/Caffeine intake within 6 hours of SDF measurement'}, 'identificationModule': {'nctId': 'NCT02376192', 'briefTitle': 'Maternal Microcirculation & SDF Imaging', 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.', 'orgStudyIdInfo': {'id': 'IWK1010276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Bolus Phenylephrine/Ephedrine Treatment'", 'description': 'Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants who experience hypotension will receive bolus phenylephrine and/or ephedrine treatment as needed.', 'interventionNames': ['Device: Initial MicroScan® (Microvision Medical) SDF Measurement', 'Drug: Spinal Anesthesia- Bupivacaine', 'Device: Comparative MicroScan® (Microvision Medical) SDF Measurement', 'Drug: Bolus Phenylephrine/Ephedrine Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Phenylephrine Infusion Group', 'description': 'Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.', 'interventionNames': ['Device: Initial MicroScan® (Microvision Medical) SDF Measurement', 'Drug: Spinal Anesthesia- Bupivacaine', 'Device: Comparative MicroScan® (Microvision Medical) SDF Measurement', 'Drug: Phenylephrine Infusion']}], 'interventions': [{'name': 'Initial MicroScan® (Microvision Medical) SDF Measurement', 'type': 'DEVICE', 'description': 'Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.', 'armGroupLabels': ["Bolus Phenylephrine/Ephedrine Treatment'", 'Phenylephrine Infusion Group']}, {'name': 'Spinal Anesthesia- Bupivacaine', 'type': 'DRUG', 'description': 'The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.', 'armGroupLabels': ["Bolus Phenylephrine/Ephedrine Treatment'", 'Phenylephrine Infusion Group']}, {'name': 'Comparative MicroScan® (Microvision Medical) SDF Measurement', 'type': 'DEVICE', 'description': 'A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.', 'armGroupLabels': ["Bolus Phenylephrine/Ephedrine Treatment'", 'Phenylephrine Infusion Group']}, {'name': 'Bolus Phenylephrine/Ephedrine Treatment', 'type': 'DRUG', 'description': 'Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.', 'armGroupLabels': ["Bolus Phenylephrine/Ephedrine Treatment'"]}, {'name': 'Phenylephrine Infusion', 'type': 'DRUG', 'description': 'Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.', 'armGroupLabels': ['Phenylephrine Infusion Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Ronald B George, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre, Dalhousie University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IWK Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Medical Research', 'investigatorFullName': 'Ronald George', 'investigatorAffiliation': 'IWK Health Centre'}}}}