Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02733835
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2015-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects: pruritus', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Pruritus'}, {'measure': 'Side effects: nausea vomiting', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Nausea/vomiting'}, {'measure': 'Side effects: sedation', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Sedation'}, {'measure': 'Maternal outcomes: duration of labour', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Duration of labour (minutes)'}, {'measure': 'Maternal outcomes: duration of second stage', 'timeFrame': 'At delivery, an expected average of 1 hour', 'description': 'Duration of second stage (minutes)'}, {'measure': 'Maternal outcomes: pain score', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Maternal pain score (out of 10)'}, {'measure': 'Maternal outcomes: satisfaction score', 'timeFrame': 'Duration of labour, an expected average of 24 hours', 'description': 'Maternal satisfaction score (%)'}, {'measure': 'Neonatal outcomes: birth weight', 'timeFrame': 'Immediately after birth', 'description': 'Birth weight in grams'}, {'measure': 'Neonatal outcomes: APGAR', 'timeFrame': 'Immediately after birth', 'description': 'APGAR scores'}, {'measure': 'Neonatal outcomes: cord blood pH', 'timeFrame': 'Immediately after birth', 'description': 'Umbilical cord blood pH'}], 'primaryOutcomes': [{'measure': 'Maternal desaturation', 'timeFrame': 'Duration of labour'}], 'secondaryOutcomes': [{'measure': 'Maternal bradycardia', 'timeFrame': 'Duration of labour, an expected average of 24 hours'}, {'measure': 'Apnoea/hypopnoea', 'timeFrame': 'Duration of labour, an expected average of 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia', 'detailedDescription': "This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates 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 pump and step down doses accordingly when predefined critical values are reached."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', '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 or with contraindication to epidural analgesia (eg. thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)\n* Gestational age of \\>= 36 weeks\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 analogue\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': 'NCT02733835', 'briefTitle': 'VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CIRB/2015/2352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remifentanil', 'description': 'Remifentanil Patient Controlled Analgesia', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Vital signs-controlled, patient assisted intravenous analgesia using remifentanil', 'armGroupLabels': ['Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Wan Ling Leong, MBBS FANZCA', 'role': 'CONTACT', 'email': 'leong.wan.ling@singhealth.com.sg', 'phone': '+6563941081'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Wan Ling Leong, MBBS FANZCA', 'role': 'CONTACT', 'email': 'leong.wan.ling@singhealth.com.sg', 'phone': '+6563941081'}, {'name': 'Ban Leong Sng, MBBS FANZCA', 'role': 'CONTACT', 'email': 'sng.ban.leong@singhealth.com.sg', 'phone': '+6563941081'}], 'overallOfficials': [{'name': 'Wan Ling Leong, MBBS FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}