Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-01 @ 6:40 PM
Study NCT ID:
NCT05097950
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2021-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labor Induction and Pain Relief With Paracetamol Versus Placebo
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2021-09-12', 'studyFirstSubmitQcDate': '2021-10-17', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN assessment during catheter balloon insertion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10'}, {'measure': 'maternal satisfaction', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'maternal satisfaction will be evaluated using a questionnaire'}], 'secondaryOutcomes': [{'measure': 'need for additional analgesic agent', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'need for additional analgesic agent than paracetamol after catheter balloon insertion'}, {'measure': 'maternal mobility', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'women were asked through a questionnaire about whether they were immoblile after the catheter insetion using a score from 0 to 10'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.', 'detailedDescription': 'Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.\n\nassessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.\n\nAn assessment of pain management will also be conducted using various assessment tools:\n\n1. Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.\n2. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.\n3. Patient Experience Questionnaire - upon transfer to delivery room.\n4. Socio-demographic Questionnaire\n\nAdditionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity\n\nExclusion Criteria:\n\n1. Sensitivity to paracetamol.\n2. Past Cesarean section\n3. Multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT05097950', 'briefTitle': 'Labor Induction and Pain Relief With Paracetamol Versus Placebo', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter', 'orgStudyIdInfo': {'id': '0065-21-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'Administration of 1 gr paracetamol I.V', 'interventionNames': ['Drug: Administration of 1 gr paracetamol I.V']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Administration of 100 ml. sodium chloride 0.9% IV', 'interventionNames': ['Drug: Administration of 1 gr paracetamol I.V']}], 'interventions': [{'name': 'Administration of 1 gr paracetamol I.V', 'type': 'DRUG', 'description': 'Administration of 1 gr paracetamol I.V', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2210001', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Inshirah Sgayer', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'inshirah sgayer', 'investigatorFullName': 'Inshirah Sgayer', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}