Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT07203651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-06-22', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': '6 months', 'description': 'relief of labour associated bachache using visual analogue pain scale. Scale is from 0 to 10 score. Score 0 means no pain and Score 10 keans worst possible pain.\n\n1-2 Score: Mild pain 3-4 score: moderate pain 5-6 score: severe pain 7-8 score: very severe 9-10: worst pain possible Having lower scores means better outcome in terms of pain relief'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labour Analgesia']}, 'descriptionModule': {'briefSummary': 'Comparison of Intradermal sterile water injection with diclofenac for relief of labour associated bachache'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'pregnant females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females in active stage of labour\n\nExclusion Criteria:\n\n* females asking for epidural'}, 'identificationModule': {'nctId': 'NCT07203651', 'briefTitle': 'Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pakistan Institute of Medical Sciences'}, 'officialTitle': 'Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache', 'orgStudyIdInfo': {'id': 'Pakistan Institute of Medical'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group receiving intradermal sterile water injection', 'interventionNames': ['Drug: Sterile Water Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Group receiving diclofenac injection', 'interventionNames': ['Drug: Diclofenac']}], 'interventions': [{'name': 'Sterile Water Injection', 'type': 'DRUG', 'description': 'WE will compare effectiveness of intradermal sterile water injection with intramuscular diclofenal', 'armGroupLabels': ['group receiving intradermal sterile water injection']}, {'name': 'Diclofenac', 'type': 'DRUG', 'description': 'comparing effectiveness of diclofenac with intradermal sterile water injection', 'armGroupLabels': ['Group receiving diclofenac injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46604', 'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Pakistan Institute of Medical Sciences', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate resident', 'investigatorFullName': 'Sidra Rauf', 'investigatorAffiliation': 'Pakistan Institute of Medical Sciences'}}}}