Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-12 @ 8:01 AM
Study NCT ID:
NCT02122705
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case Series of VPIA Using Remifentanil for Labour and Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neonatal outcomes', 'timeFrame': 'Duration of labour and one day post delivery', 'description': 'Birth weight APGAR scores at 1 and 5 minutes umbilical cord blood pH'}], 'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Duration of labour', 'description': 'Hourly maternal pain scores'}], 'secondaryOutcomes': [{'measure': 'Remifentanil drug consumption', 'timeFrame': 'Duration of labour', 'description': 'Total and hourly remifentanil drug consumption.'}, {'measure': 'Maternal side effects', 'timeFrame': 'Duration of labour and 1st day post delivery', 'description': 'Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting'}, {'measure': 'Maternal outcomes', 'timeFrame': 'Duration of labour and one day post delivery', 'description': 'Mode of delivery Duration of second stage Overall satisfaction with labour analgesia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Remifentanil', 'Labour analgesia'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.', 'detailedDescription': "This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.\n\nThe system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term parturients presenting to the hospital delivery suite in labour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who choose to use parenteral opioid for pain relief with informed consent\n* Patients who refuse labour epidural analgesia\n* Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)\n\nExclusion Criteria:\n\n* Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses\n* Patients with difficulty in communication due to language differences\n* Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogs\n* Patients with severe respiratory disease\n* Patients with history of drug dependence of recreational drug abuse\n* Patients with unmanaged foetal bradycardia'}, 'identificationModule': {'nctId': 'NCT02122705', 'acronym': 'VPIA', 'briefTitle': 'A Case Series of VPIA Using Remifentanil for Labour and Delivery', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery', 'orgStudyIdInfo': {'id': 'CIRB/2012/264/D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VPIA remifentanil', 'description': 'VPIA remifentanil labour analgesia', 'interventionNames': ['Device: VPIA remifentanil']}], 'interventions': [{'name': 'VPIA remifentanil', 'type': 'DEVICE', 'description': 'Vital signs controlled patient assisted intravenous analgesia using remifentanil', 'armGroupLabels': ['VPIA remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's & Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Wan Ling Leong, MBBS FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's & Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}