Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-27 @ 7:42 PM
Study NCT ID:
NCT02578251
Status:
UNKNOWN
Last Update Posted:
2015-10-16
First Post:
2015-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol for Intrapartum Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D008614', 'term': 'Meperidine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-15', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.', 'timeFrame': '4 hours', 'description': 'Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 \\[no pain\\] to 10 \\[worst possible pain\\].'}]}, 'conditionsModule': {'conditions': ['Analgesia, Obstetrical']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparity\n* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)\n* Maternal age between 20-30 years\n* Singleton term pregnancy (37-42 weeks of gestation)\n* Vertex-presenting fetus\n\nExclusion Criteria:\n\n* Clinical evidence of cephalopelvic disproportion\n* Scarred uterus; previous cesarean section, hysterotomy or myomectomy\n* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment\n* Fetal distress\n* Receiving any regional or parenteral analgesia before recruitment in the study\n* Known hypersensitivity to the drug family'}, 'identificationModule': {'nctId': 'NCT02578251', 'briefTitle': 'Paracetamol for Intrapartum Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IP-PCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracetamol', 'description': 'Patients will receive paracetamol intravenously (1 g in 100 mL) over 15 minutes (single dose), as an analgesic during the first stage of labor, given by a member of the study team.', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pethidine', 'description': 'Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.', 'interventionNames': ['Drug: Pethidine']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'armGroupLabels': ['Paracetamol']}, {'name': 'Pethidine', 'type': 'DRUG', 'armGroupLabels': ['Pethidine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'TA', 'investigatorFullName': 'Hamdy Bakry Mohye Soliman El Kinawy', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}