Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-28 @ 9:33 AM
Study NCT ID:
NCT02999594
Status:
UNKNOWN
Last Update Posted:
2016-12-23
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-24', 'releaseDate': '2018-03-23'}], 'estimatedResultsFirstSubmitDate': '2018-03-23'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-17', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': 'at 2nd hour of administration', 'description': 'visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'at the end of labor( within 12 hours)', 'description': 'scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied'}, {'measure': 'fetal distress', 'timeFrame': 'during labor', 'description': 'fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)'}, {'measure': 'duration of 1st and 2nd stage of labor', 'timeFrame': '1st and 2nd stage'}, {'measure': 'women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness', 'timeFrame': 'till the end of labor', 'description': 'increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol'}, {'measure': 'neonatal safety in terms of apgar score and nicu admission', 'timeFrame': 'apgar score at 0 and 5 min'}, {'measure': 'need for caesarean section or instrumental delivery', 'timeFrame': 'during labor', 'description': 'emergency caesarean section or need for forceps or vacuum application'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tramadol for Labor Analgesia']}, 'descriptionModule': {'briefSummary': 'Tramadol for labor analgesia: a low risk placebo controlled randomised control trial', 'detailedDescription': 'Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* delivering for first time(nulliparous)\n* well established labor ( 3 or more contractions in a span of ten minutes\n* cervical dilation of 4 cm or more\n* \\>= 80% effacement of cervix\n\nExclusion Criteria:\n\n* any medical disorder- diabetes,hypertension\n* obstetric high risk factors'}, 'identificationModule': {'nctId': 'NCT02999594', 'briefTitle': 'Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maulana Azad Medical College'}, 'officialTitle': 'Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial', 'orgStudyIdInfo': {'id': 'mamc123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tramadol', 'description': '50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic', 'interventionNames': ['Drug: Tramadol Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'distilled water', 'description': '2ml distilled water intramuscularly will be used as a placebo.', 'interventionNames': ['Drug: Distilled Water']}], 'interventions': [{'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'description': '50mg intramuscularly', 'armGroupLabels': ['tramadol']}, {'name': 'Distilled Water', 'type': 'DRUG', 'description': '2ml intramuscularly', 'armGroupLabels': ['distilled water']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'dr aastha raheja', 'role': 'CONTACT', 'email': 'aastha_raheja2000@yahoo.com', 'phone': '8586032882'}, {'name': 'dr krishna agarwal', 'role': 'CONTACT', 'email': 'drkrishna.agarwal@gmail.com', 'phone': '9871214208'}], 'overallOfficials': [{'name': 'dr aastha raheja', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maulana Azad Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maulana Azad Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'post graduate 1st year student obstetrics and gynecology department', 'investigatorFullName': 'dr aastha raheja', 'investigatorAffiliation': 'Maulana Azad Medical College'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-23', 'type': 'RELEASE'}, {'date': '2018-10-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'dr aastha raheja, post graduate 1st year student obstetrics and gynecology department, Maulana Azad Medical College'}}}}